Effectiveness of a Web-Based Cognitive-Behavioral Tool to Improve Mental Well-Being in the General Population: Randomized Controlled Trial

Background Interventions to promote mental well-being can bring benefits to the individual and to society. The Internet can facilitate the large-scale and low-cost delivery of individually targeted health promoting interventions. Objective To evaluate the effectiveness of a self-directed Internet-delivered cognitive-behavioral skills training tool in improving mental well-being in a population sample. Methods This was a randomized trial with a waiting-list control. Using advertisements on a national health portal and through its mailing list, we recruited 3070 participants aged 18 or over, resident in England, and willing to give their email address and access a fully automated Web-based intervention. The intervention (MoodGYM) consisted of 5 interactive modules that teach cognitive-behavioral principles. Participants in the intervention arm received weekly email reminders to access the intervention. The control group received access to the intervention after the trial was completed and received no specific intervention or email reminders. Outcomes were assessed by using self-completion questionnaires. The primary outcome was mental well-being measured with the Warwick-Edinburgh Mental Well-being Scale (WEMWBS). Secondary outcomes were Center for Epidemiologic Studies Depression scale (CES-D) depression scores, Generalized Anxiety Disorder 7-item scale (GAD-7) anxiety scores, EuroQol Group 5-Dimension Self-Report Questionnaire (EQ-5D) quality of life scores, physical activity, and health service use. All outcomes were measured at baseline, and at 6- and 12-week follow-ups. Results A total of 1529 (49.80%) participants completed final follow-up at 12 weeks. Retention was 73.11% (1123/1536) in the control arm and 26.47% (406/1534) in the intervention arm. No relationship between baseline measures and withdrawal could be established. The analysis of WEMWBS mental well-being scores using a linear mixed model for repeated measures showed no difference between intervention and control group at baseline (difference –0.124 points, 95% CI –0.814 to 0.566), and significant improvements for the intervention group at 6 weeks (2.542 points, 95% CI 1.693-3.390) and at 12 weeks (2.876 points, 95% CI 1.933-3.819). The model showed a highly significant (P<.001) intervention by time interaction effect. There were also significant improvements in self-rated scores of depression and anxiety. Given the high level of attrition, a sensitivity analysis with imputed missing values was undertaken that also showed a significant positive effect of the intervention. Conclusions Participants allocated to the intervention arm had an average increase of approximately 3 points on the WEMWBS scale compared to no increase for participants in the control group. Three points on this scale is approximately one-third of a standard deviation. In a low-cost automated intervention designed to shift the population distribution of mental well-being, a small difference per individual could yield a major benefit in population terms. In common with other Web-based interventions, there were high rates of attrition. Further work is needed to improve acceptability, to evaluate against placebo effect, and to disaggregate the effect on mental well-being from the effect on depression and anxiety. Trial Registration International Standard Randomised Controlled Trial Number Register ISRCTN 48134476; http://www.controlled-trials.com/ISRCTN48134476 (Archived by WebCite® at http://www.webcitation.org/6DFgW2p3Q)

If you might be interested in taking part then please read the information on this page. Once you have read it please use the buttons at the foot of the page to tell us whether or not you want to volunteer.

Information about the research:
We have provided answers to the following frequently asked questions: • What is the purpose of the study? • Do I need to have a mental health problem? • Do I have to take part? • What will happen to me if I volunteer?
• What do I have to do if I take part in the research?
• What is the website that is being tested?
• What are the alternatives for treatment?
• What are the side effects of any treatment received when taking part?
• What are the possible disadvantages and risks of taking part?
• What are the possible benefits of taking part?
• What happens when the research trial stops?
• What if there is a problem?
• Will my taking part in this trial be kept confidential?
• What will happen if I don't want to carry on with the study?
• What will happen to the results of the study? • Who is organising and funding the research?
• Who has reviewed the study? What is the purpose of the study?
The purpose of the study is to find out whether a website training programme can improve a person's mental (psychological) wellbeing. The website training programme offers the opportunity for people to learn new skills in how to think and how to behave. It aims to help people to identify unhelpful patterns of thinking or behaviour, and then helps them learn how to change these.

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Do I need to have a mental health problem?
No. This study is testing whether an internet programme can help everybody improve their mental wellbeing.
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Do I have to take part?
No. It is up to you whether you want to take part or not. You can say no now, or you can withdraw at a later date if you change your mind. If you decide not to take part, or if you change your mind later it will have no effect on any care you receive from the NHS.
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What will happen to me if I volunteer?
We will ask you for some details about your age and where you live to see whether you are eligible to take part. We only want volunteers who are aged 18 or over and who live in England. If you are eligible then we will ask you to give us your email address so we can contact you again in two days time. The reason for the two day delay is so that you have time to think about whether or not you really do want to take part in this research.
When we email you we will ask you to visit a website where you will be asked to confirm whether or not you still want to take part. If you do we will then ask you to fill in a questionnaire which asks questions about yourself and how you are feeling. These questions will take between 5 and 10 minutes to answer. Once this has been done you will be randomly selected to go into one of two groups. One group will be given access to the website training tool, while the other group (the "waiting list" group) will be told that they will have to wait for 12 weeks before they can have access. Volunteers in both groups will be asked to answer some more questions in 6 weeks time and in 12 weeks time. Again, the questions will take between 5 and 10 minutes to answer. The only contact we will have with you is by email.
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What do I have to do if I take part in the research?
We would like you to work through the training programme by logging in to the website. It has 5 modules and we recommend people make time to do one module a week. Each module takes 20--30 minutes to complete. After 6 weeks we will ask you to fill in some more questionnaires, and again after 12 weeks. To fill in the questionnaires will take about 10 minutes. That is all you have to dothe research just involves using a website and filling in online questionnaires. You do not have to travel anywhere or speak to anyone. If you are in the "waiting list" group then you will need to wait for 12 weeks before you have access to the website.

What is the website that is being tested?
The website is a self--directed training programme which teaches the principles of cognitive behavioural therapy. This means that people can learn useful ways of thinking and behaving to cope with stressful situations.
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What are the alternatives for treatment?
This online training programme is not being tested as a treatment. We are seeing whether it can help improve mental wellbeing as an addition to your usual lifestyle. The alternative is to do what you normally do.

What are the side effects of any treatment received when taking part?
This is a training programme on a website. There are no side effects although it will take up some of your time to do the training.
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What are the possible disadvantages and risks of taking part?
This is a website training programme. If it doesn't work for you, or you to decide not to continue with it, then it will have used up the time you have spent on the site.

What are the possible benefits of taking part?
If the training programme works then in the short term you may experience an increase in your psychological wellbeing and in the longer term you may have learned more healthy ways of thinking and behaving.

What happens when the research trial stops?
We will send you an email to thank you for taking part. We will also send you a summary of what the research found. We will also send you a link to a website where you can carry on using the training programme free if you want to.

What if there is a problem?
If there is a technical problem with using the site then please contact our email support line on psywellsupport@anu.edu.au. If you have any other kinds of problem then please contact the research team at the University of Warwick (details below).

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Will my part in this trial be kept confidential?
Yes. In order to use the website and fill in our questionnaires we need to know your email address but we do not need to know your full name or address. All the information we have on you will be kept confidential and will not be used for any purpose other than this research. When the research has finished we will delete all personal information (i.e. your email address).
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What will happen if I don't want to carry on with the study?
You are free to leave the study at any time without giving a reason. If you do decide to leave the study we will send you an email to confirm that you have withdrawn and we will ask for any feedback that you would like to give us (but you do not have to give any).

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What will happen to the results of the study?
We will write a report for the Department of Health in England and we will publish the results in scientific journals. No reports will contain any personal information from participants.

Who is organising and funding the research?
The research is being organised by a team at the University of Warwick, and is supported by NHS Choices and the Department of Health.