A Technology-Assisted Telephone Intervention for Work-Related Stress Management: Pilot Randomized Controlled Trial

Background Stress management interventions combining technology with human involvement have the potential to improve the cost-effectiveness of solely human-delivered interventions, but few randomized controlled trials exist for assessing the cost-effectiveness of technology-assisted human interventions. Objective The aim of this study was to investigate whether a technology-assisted telephone intervention for stress management is feasible for increasing mental well-being or decreasing the time use of coaches (as an approximation of intervention cost) while maintaining participants’ adherence and satisfaction compared with traditional telephone coaching. Methods A 2-arm, pilot randomized controlled trial of 9 months for stress management (4-month intensive and 5-month maintenance phases) was conducted. Participants were recruited on the web through a regional occupational health care provider and randomized equally to a research (technology-assisted telephone intervention) and a control (traditional telephone intervention) group. The coaching methodology was based on habit formation, motivational interviewing, and the transtheoretical model. For the research group, technology supported both coaches and participants in identifying behavior change targets, setting the initial coaching plan, monitoring progress, and communication. The pilot outcome was intervention feasibility, measured primarily by self-assessed mental well-being (WorkOptimum index) and self-reported time use of coaches and secondarily by participants’ adherence and satisfaction. Results A total of 49 eligible participants were randomized to the research (n=24) and control (n=25) groups. Most participants were middle-aged (mean 46.26, SD 9.74 years) and female (47/49, 96%). Mental well-being improved significantly in both groups (WorkOptimum from “at risk” to “good” Â>0.85; P<.001), and no between-group differences were observed in the end (Â=0.56, 95% CI 0.37-0.74; P=.56). The total time use of coaches did not differ significantly between the groups (366.0 vs 343.0 minutes, Â=0.60, 95% CI 0.33-0.85; P=.48). Regarding adherence, the dropout rate was 13% (3/24) and 24% (6/25), and the mean adherence rate to coaching calls was 92% and 86% for the research and control groups, respectively; the frequency of performing coaching tasks was similar for both groups after both phases; and the diligence in performing the tasks during the intensive phase was better for the research group (5.0 vs 4.0, Â=0.58, 95% CI 0.51-0.65; P=.03), but no difference was observed during the maintenance phase. Satisfaction was higher in the research group during the intensive phase (5.0 vs 4.0, Â=0.66, 95% CI 0.58-0.73; P<.001) but not during the maintenance phase. Conclusions The technology-assisted telephone intervention is feasible with some modifications, as it had similar preliminary effectiveness as the traditional telephone intervention, and the participants had better satisfaction with and similar or better adherence to the intervention, but it did not reduce the time use of coaches. The technology should be improved to provide more digested information for action planning and templates for messaging. Trial Registration ClinicalTrials.gov NCT02445950; https://www.clinicaltrials.gov/ct2/show/study/NCT02445950


Adherence, satisfaction with coaching
Recommended "Dose" * What do the instructions for users say on how often the app should be used?
• Approximately Daily • Approximately Weekly • Approximately Monthly • Approximately Yearly • "as needed" • Muu: Approx. Percentage of Users (starters) still using the app as recommended after 3 months * • unknown / not evaluated Overall, was the app/intervention effective? * • yes: all primary outcomes were significantly better in intervention group vs control • partly: SOME primary outcomes were significantly better in intervention group vs control • no statistically significant difference between control and intervention • potentially harmful: control was significantly better than intervention in one or more outcomes • inconclusive: more research is needed • Muu: Article Preparation Status/Stage * At which stage in your article preparation are you currently (at the time you fill in this form) • not submitted yet -in early draft status • not submitted yet -in late draft status, just before submission • submitted to a journal but not reviewed yet • submitted to a journal and after receiving initial reviewer comments • submitted to a journal and accepted, but not published yet • published • Muu:

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1a-i) Identify the mode of delivery in the title
Identify the mode of delivery. Preferably use "web-based" and/or "mobile" and/or "electronic game" in the title. Avoid ambiguous terms like "online", "virtual", "interactive". Use "Internetbased" only if Intervention includes non-web-based Internet components (e.g. email), use "computer-based" or "electronic" only if offline products are used. Use "virtual" only in the context of "virtual reality" (3-D worlds). Use "online" only in the context of "online support groups". Complement or substitute product names with broader terms for the class of products (such as "mobile" or "smart phone" instead of "iphone"), especially if the application runs on different platforms. subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 1a-i? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes. "Technology-assisted telephone Intervention". Intervention main delivery was through telephone coaching, which was complemented e.g. by profiling to support the coach and messaging via web-based coaching platform.

1a-ii) Non-web-based components or important co-interventions in title
Mention non-web-based components or important co-interventions in title, if any (e.g., "with telephone support"). subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 1a-ii? Yes. "Technology-assisted telephone Intervention" 1a-iii) Primary condition or target group in the title Mention primary condition or target group in the title, if any (e.g., "for children with Type I Diabetes") Example: A Web-based and Mobile Intervention with Telephone Support for Children with Type I Diabetes: Randomized Controlled Trial subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 1a-iii? * Yes. " Work-Related Stress " 1b) ABSTRACT: Structured summary of trial design, methods, results, and conclusions NPT extension: Description of experimental treatment, comparator, care providers, centers, and blinding status.

1b-i) Key features/functionalities/components of the intervention and comparator in the METHODS section of the ABSTRACT
Mention key features/functionalities/components of the intervention and comparator in the abstract. If possible, also mention theories and principles used for designing the site. Keep in mind the needs of systematic reviewers and indexers by including important synonyms. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 1b-i? * Yes. " The coaching methodology was based on habit formation, motivational interviewing and the transtheoretical model. For the research group, technology supported both the coaches and participants in identifying behaviour change targets, setting the initial coaching plan, progress monitoring, and communication."

1b-ii) Level of human involvement in the METHODS section of the ABSTRACT
Clarify the level of human involvement in the abstract, e.g., use phrases like "fully automated" vs. "therapist/nurse/care provider/physician-assisted" (mention number and expertise of providers involved, if any). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 1b-ii? Yes. "For the research group, technology supported both the coaches and participants in identifying behaviour change targets, setting the initial coaching plan, progress monitoring, and communication. " 1b-iii) Open vs. closed, web-based (self-assessment) vs. face-to-face assessments in the METHODS section of the ABSTRACT Mention how participants were recruited (online vs. offline), e.g., from an open access website or from a clinic or a closed online user group (closed usergroup trial), and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment). Clearly say if outcomes were self-assessed through questionnaires (as common in web-based trials). Note: In traditional offline trials, an open trial (open-label trial) is a type of clinical trial in which both the researchers and participants know which treatment is being administered. To avoid confusion, use "blinded" or "unblinded" to indicated the level of blinding instead of "open", as "open" in web-based trials usually refers to "open access" (i.e. participants can self-enrol). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 1b-iii? Yes. "Participants were recruited online through a regional occupational health care provider, and randomized equally to a research (technology-assisted telephone intervention) and a control (traditional telephone intervention) group. " ..." Pilot outcome was intervention feasibility measured primarily by the self-assessed mental well-being (WorkOptimum index) and the self-reported time use of coaches, and secondarily by participants' adherence and satisfaction" 1b-iv) RESULTS section in abstract must contain use data Report number of participants enrolled/assessed in each group, the use/uptake of the intervention (e.g., attrition/adherence metrics, use over time, number of logins etc.), in addition to primary/secondary outcomes. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 1b-iv? Yes. "Regarding adherence, the dropout rate was 12.50% (3/24) and 24.00% (6/25), and the mean adherence rate to coaching calls was 91.67% and 85.50% for the research and control groups, respectively "

1b-v) CONCLUSIONS/DISCUSSION in abstract for negative trials
Conclusions/Discussions in abstract for negative trials: Discuss the primary outcome -if the trial is negative (primary outcome not changed), and the intervention was not used, discuss whether negative results are attributable to lack of uptake and discuss reasons. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) subitem not at all important 1 2 3 4 5 essential

2a-i) Problem and the type of system/solution
Describe the problem and the type of system/solution that is object of the study: intended as standalone intervention vs. incorporated in broader health care program? Intended for a particular patient population? Goals of the intervention, e.g., being more cost-effective to other interventions, replace or complement other solutions? (Note: Details about the intervention are provided in "Methods" under 5) subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 2a-i? * Yes. "Work-related stress and its indirect consequences for physical, mental and social well-being are serious threats to public health."... "The previous research suggests that blended interventions have the potential to be effective, but cost-effectiveness studies are lacking for the stress management with technology-assisted human interventions (C2). Furthermore, adherence and satisfaction are important for evaluating the feasibility of interventions in more detail, and helping to refine their implementation for future large-scale RCT."..."The primary objective of this study was to investigate whether a technology-assisted telephone intervention (C2) for stress management is feasible for increasing participants' well-being or decreasing the time use of coaches, while maintaining participants' adherence and satisfaction compared to a traditional telephone intervention (C1) in an occupational health care setting"

2a-ii) Scientific background, rationale:
What is known about the (type of) system Scientific background, rationale: What is known about the (type of) system that is the object of the study (be sure to discuss the use of similar systems for other conditions/diagnoses, if appropiate), motivation for the study, i.e. what are the reasons for and what is the context for this specific study, from which stakeholder viewpoint is the study performed, potential impact of findings [2]. Briefly justify the choice of the comparator. subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 2a-ii? * Yes. " interventions are often supported with technology or they can be even fully digital. The use of technology can decrease human involvement and thus costs, which enables scaling up the intervention for a larger population and, therefore, holds a promise of a healthier population."…"This suggests that the optimal solution could be a blended intervention (C2-C4),maximizing the scalability and effectiveness."... "The previous research suggests that blended interventions have the potential to be effective, but cost-effectiveness studies are lacking for the stress management with technology-assisted human interventions (C2)."

2b) In INTRODUCTION: Specific objectives or hypotheses
Does your paper address CONSORT subitem 2b? * Yes. "The primary objective of this study was to investigate whether a technology-assisted telephone intervention (C2) for stress management is feasible for increasing participants' well-being or decreasing te time use of coaches, while maintaining participants' adherence and satisfaction compared to a traditional telephone intervention (C1) in an occupational health care setting." METHODS 3a) Description of trial design (such as parallel, factorial) including allocation ratio Does your paper address CONSORT subitem 3a? * Yes. "A non-blinded, parallel-group, two-arm pilot RCT of nine months was conducted in Oulu, Finland, to explore whether a technology-assisted telephone intervention for stress management is feasible for increasing mental well-being or decreasing time use of coaches, while maintaining adherence and satisfaction." ..."The eligible participants were randomly allocated either to a research (technology-assisted telephone intervention) or control (traditional telephone intervention) group in a 1:1 ratio, using stratified block randomization." 3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons Does your paper address CONSORT subitem 3b? * No. There was no important changes to methods.

3b-i) Bug fixes, Downtimes, Content Changes
Bug fixes, Downtimes, Content Changes: ehealth systems are often dynamic systems. A description of changes to methods therefore also includes important changes made on the intervention or comparator during the trial (e.g., major bug fixes or changes in the functionality or content) (5-iii) and other "unexpected events" that may have influenced study design such as staff changes, system failures/downtimes, etc.

Does your paper address subitem 3b-i?
No. In our study there was no remarkable bug fixes, down times or content changes during the study.

4a) Eligibility criteria for participants
Does your paper address CONSORT subitem 4a? * Yes. ". The eligibility criteria are presented in Table 1."

4a-i) Computer / Internet literacy
Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clarified. subitem not at all important 1 2 3 4 5 essential

Does your paper address subitem 4a-i?
No. Computer literacy was not inquired from the participants.

4a-ii) Open vs. closed, web-based vs. face-to-face assessments:
Open vs. closed, web-based vs. face-to-face assessments: Mention how participants were recruited (online vs. offline), e.g., from an open access website or from a clinic, and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment), i.e., to what degree got the study team to know the participant. In online-only trials, clarify if participants were quasi-anonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email confirmation, phone calls) were used to detect/prevent these. subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 4a-ii? * Yes. "The recruitment announcement was published on the intranet…, and in the magazines… occupational healthcare provider also recruited participants personally and via email. The registration to the study was conducted online via a link ... The registered employees received informed consent by regular mail... The signed consents were collected by a research partner, who provided the coaching service for the intervention. An electronic eligibility survey was sent to the employees who returned the signed consents, and they were informed of the inclusion or exclusion via email."… "There were two interventions: technology assisted telephone intervention and traditional telephone intervention."

4a-iii) Information giving during recruitment
Information given during recruitment. Specify how participants were briefed for recruitment and in the informed consent procedures (e.g., publish the informed consent documentation as appendix, see also item X26), as this information may have an effect on user self-selection, user expectation and may also bias results. subitem not at all important 1 2 3 4 5 essential

Does your paper address subitem 4a-iii?
Yes. "The registered employees received informed consent by regular mail, where information was provided regarding the two study groups, intervention, data collection, data processing, data privacy, research partners and contact details." 4b) Settings and locations where the data were collected Does your paper address CONSORT subitem 4b? * Yes. "employees of the City of Oulu"

4b-i) Report if outcomes were (self-)assessed through online questionnaires
Clearly report if outcomes were (self-)assessed through online questionnaires (as common in webbased trials) or otherwise. subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 4b-i? * Yes. "The pilot outcome was intervention feasibility measured primarily by the participants' selfassessed mental well-being and the total time use of the coaches for the complete coaching period and secondarily by participants' adherence to and satisfaction with coaching. "…" For each coaching call, the coaches were asked to manually record the duration of the call and the time spent preparing for them (in minutes)."… "During the intensive phase, the coaches evaluated the task performance adherence (frequency and diligence)"…" During the maintenance phase, the participants self-assessed their task performance adherence for each coaching task via three electronic questionnaires administered at months 5, 7, and 9 (after calls #6-8 for the control group) (APPENDIX B)."… "Participants' satisfaction with coaching was assessed with one question at different phases of the trial. For the research group, during the intensive phase the statement was: "I was satisfied with the coaching call" and during the maintenance phase "I was satisfied with the coaching received via Movendos messages." For the control group the statement remained the same through the intervention, "I was satisfied with the coaching call."

4b-ii) Report how institutional affiliations are displayed
Report how institutional affiliations are displayed to potential participants [on ehealth media], as affiliations with prestigious hospitals or universities may affect volunteer rates, use, and reactions with regards to an intervention.(Not a required itemdescribe only if this may bias results) subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 4b-ii?
5) The interventions for each group with sufficient details to allow replication, including how and when they were actually administered 5-i) Mention names, credential, affiliations of the developers, sponsors, and owners Mention names, credential, affiliations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a "Conflict of interest" section or mentioned elsewhere in the manuscript). subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-i? Yes. "At the beginning of the intensive phase, the research group received Firstbeat heart rate variability (HRV) sensors and wore them for three days (Firstbeat Technologies Ltd., see more details below)"..."a Fitbit activity bracelet (Fitbit Inc.) was provided."... "Oiva stress management web service based on acceptance and commitment therapy (Oiva) was offered. "..."During the project, a web-tool, HRS, was developed to analyze participants' behavior change need areas and to provide a personalized recommendation of suitable behaviour change actions, i.e., coaching tasks, based on the identified needs. "... "The research group used the Movendos coaching web service (v1.27) (Movendos Ltd.)" … "Ulla-Maija Junno works at Luona Hoiva Ltd. (previously Mawell Care Ltd.), which provided the coaching for the intervention, and Hannu Nieminen works at Movendos Ltd., which provided the web coaching platform for the intervention."

5-ii) Describe the history/development process
Describe the history/development process of the application and previous formative evaluations (e.g., focus groups, usability testing), as these will have an impact on adoption/use rates and help with interpreting results. subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-ii?

5-iii) Revisions and updating
Revisions and updating. Clearly mention the date and/or version number of the application/intervention (and comparator, if applicable) evaluated, or describe whether the intervention underwent major changes during the evaluation process, or whether the development and/or content was "frozen" during the trial. Describe dynamic components such as news feeds or changing content which may have an impact on the replicability of the intervention (for unexpected events see item 3b). subitem not at all important 1 2 3 4 5 essential

5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable. subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-iv?
No. Experienced health coaches were responsible for delivering the intervention in practice. Apart from the Profiler, all the utilized technology components were in commercial use, and thus of high maturity level. Unit tests were used to verify that the Profiler worked as specified.

5-v)
Ensure replicability by publishing the source code, and/or providing screenshots/screencapture video, and/or providing flowcharts of the algorithms used Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scientific reporting. subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-v? No.

5-vi) Digital preservation
Digital preservation: Provide the URL of the application, but as the intervention is likely to change or disappear over the course of the years; also make sure the intervention is archived (Internet Archive, webcitation.org, and/or publishing the source code or screenshots/videos alongside the article). As pages behind login screens cannot be archived, consider creating demo pages which are accessible without login. subitem not at all important 1 2 3 4 5 essential

Does your paper address subitem 5-vi?
No. The webcitation tool was not in use anymore.

5-vii) Access
Access: Describe how participants accessed the application, in what setting/context, if they had to pay (or were paid) or not, whether they had to be a member of specific group. If known, describe how participants obtained "access to the platform and Internet" [1]. To ensure access for editors/reviewers/readers, consider to provide a "backdoor" login account or demo mode for reviewers/readers to explore the application (also important for archiving purposes, see vi). subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-vii? * Yes. "The used technology was free for the participants and they used them in their everyday lives." Movendos and Oiva were used via internet and coaching via telephone. Fitbit required mobile app. subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-viii? * Yes. "The coaching was based on the habit formation theory"... "The tasks were related to different topics, namely sleep, physical activity, eating, alcohol consumption, smoking, recovery from stress, anxiety, personal values, workload management, quality of relationship, self-esteem, and weight management."… "The behavioral strategies were based on motivational interviewing (MI) and the transtheoretical model (TTM) of Prochaska [66,67]"" The main difference between the interventions was the number of telephone calls and the use of technology in coaching. The research group had five coaching calls during the intensive phase and one at the end."..." Web tools and wearables were used to support the identification of the participants' behaviour change targets, the creation of the initial intervention plan, progress monitoring, and communication."..."During the maintenance phase, the research group received coaching only via the Movendos messages."... "control group received eight coaching calls" 5-ix) Describe use parameters Describe use parameters (e.g., intended "doses" and optimal timing for use). Clarify what instructions or recommendations were given to the user, e.g., regarding timing, frequency, heaviness of use, if any, or was the intervention used ad libitum. subitem not at all important 1 2 3 4 5 essential

Does your paper address subitem 5-ix?
Yes. "The research group had five coaching calls during the intensive phase and one at the end. Control group had five coaching calls in the intensive phase and three in the maintenance phase." "The coaches were expected to send group messages to the research group once a month and personal coaching messages every two weeks, in addition to replying to any messages from the participants on a weekly basis. " "The control group received eight coaching calls in total: five in the intensive phase and three in the maintenance phase." The use of Movendos from participant side was when needed.

5-x) Clarify the level of human involvement
Clarify the level of human involvement (care providers or health professionals, also technical assistance) in the e-intervention or as co-intervention (detail number and expertise of professionals involved, if any, as well as "type of assistance offered, the timing and frequency of the support, how it is initiated, and the medium by which the assistance is delivered". It may be necessary to distinguish between the level of human involvement required for the trial, and the level of human involvement required for a routine application outside of a RCT setting (discuss under item 21generalizability). subitem not at all important 1 2 3 4 5 essential

Does your paper address subitem 5-x?
Yes. "Coaching was performed by three coaches of the research partner, Mawell Care Ltd., "..."During the maintenance phase, the research group received coaching only via the Movendos messages. The coaches were expected to send group messages to the research group once a month and personal coaching messages every two weeks, in addition to replying to any messages from the participants on a weekly basis. Before sending messages, the coaches checked the participants' progress on Movendos. The coaching messages then focused on motivating them on tasks that were not progressing." [589] 5-xi) Report any prompts/reminders used Report any prompts/reminders used: Clarify if there were prompts (letters, emails, phone calls, SMS) to use the application, what triggered them, frequency etc. It may be necessary to distinguish between the level of prompts/reminders required for the trial, and the level of prompts/reminders for a routine application outside of a RCT setting (discuss under item 21generalizability). subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-xi? * Yes. "The research group used the Movendos coaching service for 1) communicating with the coach via messages (e.g., feedback), 2) progress monitoring, and 3) receiving reminders from the coach and setting reminders themselves if they so wished."

5-xii) Describe any co-interventions (incl. training/support)
Describe any co-interventions (incl. training/support): Clearly state any interventions that are provided in addition to the targeted eHealth intervention, as ehealth intervention may not be designed as stand-alone intervention. This includes training sessions and support [1]. It may be necessary to distinguish between the level of training required for the trial, and the level of training for a routine application outside of a RCT setting (discuss under item 21generalizability. subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-xii? * Yes. Movendos was the main supplementing intervention for the telephone coaching. Additionally: "Oiva stress management web service based on acceptance and commitment therapy"..."Oiva contains short few-minute exercises" " Firstbeat well-being analysis (Firstbeat Technologies Ltd.) [69] provided an analysis of the balance between activity and rest based on heartrate variability (HRV)"…"a Fitbit activity bracelet (Fitbit Inc.) was provided." 6a) Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed Does your paper address CONSORT subitem 6a? * Yes. " Mental well-being was assessed with the WorkOptimum® index, which is a measure of occupational health, aiming at detecting work-related cognitive decline and decrease in mental wellbeing before developing mental health problems (APPENDIX A) [56,57]"…" . The electronic questionnaire was administered to the participants at the baseline (month 0), and at the end of the intensive (month 4) and maintenance (month 9) phases." …" The total time use of coaches was tracked during the entire intervention regarding 1) preparation time for the coaching calls, 2) duration of the coaching calls (i.e., six calls for the research group and eight calls for the control group), and 3) the time spent on writing personal coaching messages to the research group. For each coaching call, the coaches were asked to manually record the duration of the call and the time spent preparing for them (in minutes). "… "Adherence was assessed by the dropout attrition, describing how many quit the intervention, and by the usage adherence (inversely non-usage attrition). The usage adherence comprised 1) the proportion of the realized coaching calls, 2) the frequency of performing the selected coaching tasks, and 3) diligence in performing the tasks. During the intensive phase, the coaches evaluated the task performance adherence (frequency and diligence) three times for the research group (during coaching calls #3-5) and four times for the control group (during calls #2-5) via a structured interview (APPENDIX B). For each coaching task, the following three items were assessed: "The client performed the task less frequently than agreed," "The client performed the task more frequently than agreed," and "The client performed the task with diligence," with a five-point Likert scale (1 = "Strongly disagree," 5 = "Strongly agree") also having the option "I don't know.""…" During the maintenance phase, the participants self-assessed their task performance adherence for each coaching task via three electronic questionnaires administered at months 5, 7, and 9 (after calls #6-8 for the control group) (APPENDIX B)."…" Participants' satisfaction with coaching was assessed with one question at different phases of the trial. For the research group, during the intensive phase the statement was: "I was satisfied with the coaching call" and during the maintenance phase "I was satisfied with the coaching received via Movendos messages." For the control group the statement remained the same through the intervention, "I was satisfied with the coaching call." "The satisfaction was asked at four timepoints (after calls #2-5 for the research group and after calls #3-5 for the control group) during the intensive phase and three times in the maintenance phase (after the calls #6-8 of the control group)." 6a-i) Online questionnaires: describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed If outcomes were obtained through online questionnaires, describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed [9]. subitem not at all important 1 2 3 4 5 essential

Does your paper address subitem 6a-i?
No, online questionnaires were not validated with CHERRIES.

6a-ii) Describe whether and how "use" (including intensity of use/dosage) was defined/measured/monitored
Describe whether and how "use" (including intensity of use/dosage) was defined/measured/monitored (logins, logfile analysis, etc.). Use/adoption metrics are important process outcomes that should be reported in any ehealth trial. subitem not at all important 1 2 3 4 5 essential

Does your paper address subitem 6a-ii?
Yes. "use" and adherence for following the overall intervention program. The Movendos use itself was not monitored. " The usage adherence comprised 1) the proportion of the realized coaching calls, 2) the frequency of performing the selected coaching tasks, and 3) diligence in performing the tasks "... " During the intensive phase, the coaches evaluated the task performance adherence (frequency and diligence) three times for the research group (during coaching calls #3-5) and four times for the control group (during calls #2-5) via a structured interview (APPENDIX B). "…" During the maintenance phase, the participants self-assessed their task performance adherence for each coaching task via three electronic questionnaires administered at months 5, 7, and 9 (after calls #6-8 for the control group) (APPENDIX B)."

6a-iii) Describe whether, how, and when qualitative feedback from participants was obtained
Describe whether, how, and when qualitative feedback from participants was obtained (e.g., through emails, feedback forms, interviews, focus groups). subitem not at all important 1 2 3 4 5 essential

Does your paper address subitem 6a-iii?
No. Qualitative feedback was collected with electronic questionnaires and naturally the coaches heard something. The qualitative data is not included in the analyses.
6b) Any changes to trial outcomes after the trial commenced, with reasons Does your paper address CONSORT subitem 6b? * No. There were changes made to the outcomes after the trial commenced.

7a) How sample size was determined
NPT: When applicable, details of whether and how the clustering by care provides or centers was addressed 7a-i) Describe whether and how expected attrition was taken into account when calculating the sample size Describe whether and how expected attrition was taken into account when calculating the sample size.
subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 7a-i? Yes. "The available coaching resources defined how many participants could be enrolled to the study. At the time of the study, the participating coaching service provider employed three coaches, who could use on average 20% of their time for the study participants. Therefore, the objective was to have 40 active participants in the study. Since a drop-out rate of 20% is common in telephone interventions, the aim was to recruit 50 participants."

7b) When applicable, explanation of any interim analyses and stopping guidelines
Does your paper address CONSORT subitem 7b? * No interim analyses were made.
8a) Method used to generate the random allocation sequence NPT: When applicable, how care providers were allocated to each trial group Does your paper address CONSORT subitem 8a? * Yes "The eligible participants were randomly allocated either to a research (technology-assisted telephone intervention) or control (traditional telephone intervention) group in a 1:1 ratio, using stratified block randomization. Group allocation was stratified by socio-economic status and having minors as family members, since these factors were anticipated to influence the mental well-being and adherence outcomes of the study due to challenges in meeting the demands of work and family responsibilities " 8b) Type of randomisation; details of any restriction (such as blocking and block size) Does your paper address CONSORT subitem 8b? * Yes. "The eligible participants were randomly allocated either to a research (technology-assisted telephone intervention) or control (traditional telephone intervention) group in a 1:1 ratio, using stratified block randomization." 9) Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned Does your paper address CONSORT subitem 9? * Yes. "The participants were randomized simultaneously to the two groups via Microsoft Excel (2010) using its random number generator." 10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions Does your paper address CONSORT subitem 10? * Yes. " The randomization was conducted by a researcher, who was not involved in the study as an investigator." 11a) If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how NPT: Whether or not administering co-interventions were blinded to group assignment 11a-i) Specify who was blinded, and who wasn't Specify who was blinded, and who wasn't. Usually, in web-based trials it is not possible to blind the participants [1, 3] (this should be clearly acknowledged), but it may be possible to blind outcome assessors, those doing data analysis or those administering co-interventions (if any). subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 11a-i? * No. It was not possible to blind the participants and coaches were not blinded. Also, the researchers performing the data analyses were not blinded.
11a-ii) Discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator" Informed consent procedures (4a-ii) can create biases and certain expectations -discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator". subitem not at all important 1 2 3 4 5 essential

Does your paper address subitem 11a-ii?
Yes. Information of the two interventions and the research intervention of interest were provided in the informed consent. "Registered employees received informed consents by regular mail, where information was provided regarding the two study groups, intervention, data collection, data processing, data privacy, research partners and contact details."

11b) If relevant, description of the similarity of interventions
(this item is usually not relevant for ehealth trials as it refers to similarity of a placebo or sham intervention to a active medication/intervention) Does your paper address CONSORT subitem 11b? * Yes. "The main difference between the interventions was the number of telephone calls and the use of technology in the coaching. The research group had five coaching calls during the intensive phase and one in the end. The control group had five coaching calls in the intensive phase and tree in the maintenance phase." 12a) Statistical methods used to compare groups for primary and secondary outcomes NPT: When applicable, details of whether and how the clustering by care providers or centers was addressed Does your paper address CONSORT subitem 12a? * Yes. "For the primary trial outcome, mental well-being (WorkOptimum index), Mann-Whitney U tests were conducted … to determine the statistical significance of the between-group differences"… "Similar between-group analyses were performed for the time use of coaches, participants' adherence (frequency and diligence) to and satisfaction with coaching. " …" In addition, the statistical significance of the within-group changes in mental well-being from baseline (month 0) to the end of the intensive (month 4) and the maintenance phases (month 9) were determined with the Sign test."… "The Vargha-Delaney A measure of stochastic superiority is reported as an indicator for the effect size. For the between-group analyses, also the 95% confidence intervals (CI) of the effect sizes are reported. ."

12a-i) Imputation techniques to deal with attrition / missing values
Imputation techniques to deal with attrition / missing values: Not all participants will use the intervention/comparator as intended and attrition is typically high in ehealth trials. Specify how participants who did not use the application or dropped out from the trial were treated in the statistical analysis (a complete case analysis is strongly discouraged, and simple imputation techniques such as LOCF may also be problematic [4]). subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 12a-i? * Yes. " For the different outcomes, all the participants with relevant data available were included in the analyses (available-cases analysis). "

12b) Methods for additional analyses, such as subgroup analyses and adjusted analyses
Does your paper address CONSORT subitem 12b? * No, there were no subgroup analyses performed.

X26) REB/IRB Approval and Ethical Considerations [recommended as subheading under "Methods"] (not a CONSORT item)
X26-i) Comment on ethics committee approval subitem not at all important 1 2 3 4 5 essential Does your paper address subitem X26-i? Yes. "The study was evaluated and approved by the Ethics Committee of Human Sciences at the University of Oulu."

x26-ii) Outline informed consent procedures
Outline informed consent procedures e.g., if consent was obtained offline or online (how? Checkbox, etc.?), and what information was provided (see 4a-ii). See [6] for some items to be included in informed consent documents. subitem not at all important 1 2 3 4 5 essential Does your paper address subitem X26-ii? Yes. "Informed consent was obtained from the interested individuals by regular mail before administering the electronic eligibility survey via e-mail."

X26-iii) Safety and security procedures
Safety and security procedures, incl. privacy considerations, and any steps taken to reduce the likelihood or detection of harm (e.g., education and training, availability of a hotline) subitem not at all important 1 2 3 4 5 essential

RESULTS
13a) For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome NPT: The number of care providers or centers performing the intervention in each group and the number of patients treated by each care provider in each center Does your paper address CONSORT subitem 13a? * Yes. "In total, 131 volunteers registered for the study, of which 56 met the inclusion criteria and were randomized equally to research and control groups."… "50 participants were chosen to be enrolled in the study based on the order of registration."… "At the beginning of the coaching program, one participant in the research group was no longer eligible for the study due toa change in their employment status and thus was omitted from the statistical analyses. " in Figure 3, primary analyses are marked for the research group n=21, control, n=19.
13b) For each group, losses and exclusions after randomisation, together with reasons Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT flow diagram) * Yes. "At the beginning of the coaching program, one participant in the research group was no longer eligible for the study due to a change in their employment status and thus was omitted from the statistical analyses."

13b-i) Attrition diagram
Strongly recommended: An attrition diagram (e.g., proportion of participants still logging in or using the intervention/comparator in each group plotted over time, similar to a survival curve) or other figures or tables demonstrating usage/dose/engagement. subitem not at all important 1 2 3 4 5 essential 14a-i) Indicate if critical "secular events" fell into the study period Indicate if critical "secular events" fell into the study period, e.g., significant changes in Internet resources available or "changes in computer hardware or Internet delivery resources" subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 14a-i? No. No significant changes took place.
14b) Why the trial ended or was stopped (early) Does your paper address CONSORT subitem 14b? * No, not applicable since the trial rolled out as planned.

15) A table showing baseline demographic and clinical characteristics for each group
NPT: When applicable, a description of care providers (case volume, qualification, expertise, etc.) and centers (volume) in each group Does your paper address CONSORT subitem 15? * Yes. "The baseline characteristics of the participants are presented in Table 4."

15-i) Report demographics associated with digital divide issues
In ehealth trials it is particularly important to report demographics associated with digital divide issues, such as age, education, gender, social-economic status, computer/Internet/ehealth literacy of the participants, if known. subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 15-i? * Yes. "The baseline characteristics of the participants are presented in Table 4. Most of the participants (95.92%, 47/49) were female, and the two males were allocated to the control group. More than half (57.14%, 28/49) of the participants were aged 46 to 60 years (mean age 46.26 years, SD 9.74). Most had at least the bachelor's degree (83.67%, 41/49)." 16) For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups 16-i) Report multiple "denominators" and provide definitions Report multiple "denominators" and provide definitions: Report N's (and effect sizes) "across a range of study participation [and use] thresholds" [1], e.g., N exposed, N consented, N used more than x times, N used more than y weeks, N participants "used" the intervention/comparator at specific pre-defined time points of interest (in absolute and relative numbers per group). Always clearly define "use" of the intervention. subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 16-i? * Yes, numbers of analyzed persons, statistical significance, Effect sizes etc. have been reported in Table 4 and 5.

16-ii) Primary analysis should be intent-to-treat
Primary analysis should be intent-to-treat, secondary analyses could include comparing only "users", with the appropriate caveats that this is no longer a randomized sample (see 18-i). subitem not at all important 1 2 3 4 5 essential

Does your paper address subitem 16-ii?
Yes. " Figure 3 summarizes the participant flow from registration to available-case analysis for mental well-being as the primary outcome, and the attrition numbers for the intensive and the maintenance phases together with reasons for withdrawal." 17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) Does your paper address CONSORT subitem 17a? * Yes. In Table 5 and 6, these are presented.

17a-i) Presentation of process outcomes such as metrics of use and intensity of use
In addition to primary/secondary (clinical) outcomes, the presentation of process outcomes such as metrics of use and intensity of use (dose, exposure) and their operational definitions is critical. This does not only refer to metrics of attrition (13-b) (often a binary variable), but also to more continuous exposure metrics such as "average session length". These must be accompanied by a technical description how a metric like a "session" is defined (e.g., timeout after idle time) [1] (report under item 6a). subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 17a-i? Yes. "The total time use of coaches … was not statistically significantly different between the two groups (366.0min vs 343.0min, Â=.60, 95% CI .33-.85, P =.48) (Table 5). However, the mean preparation time per coaching call was considerably higher for the research group (Â = .90, 95% CI .75-1.0, P=.001). The mean duration per call did not differ between the groups (Â=.59, 95% CI .37-.80, P=.40). Regarding the personal coaching messages, the coaches sent altogether 60 and 102 personal coaching messages to the research group participants during the intensive and the maintenance phases, respectively."