JMIR Publications

ABSTRACT

Background:

Primary headaches, including migraine and tension-type headaches (TTH), are widespread and have a social, physical, mental, and economic impact. They occur mainly during productive years (ie, between ages of 25 and 55). One of the key components of treatment are behavior interventions such as lifestyle modification. Scalable conversational agents (CAs) offer the potential to deliver behavior interventions at low threshold. To our knowledge, there is no evidence on behavioral interventions delivered by CAs for the treatment of headaches.

Objective:

This study aimed (1) to develop and test a smartphone-based coaching intervention (BalanceUP) for people suffering from frequent headaches, delivered by a conversational agent (CA), and designed to improve mental well-being by various behavior change techniques, and (2) to evaluate the effectiveness by comparing the intervention and control group, and to assess the engagement and acceptance of participants using BalanceUP.

Methods:

In a randomized controlled trial, adults with frequent headaches were recruited from a non-clinical setting and allocated to either a CA intervention (BalanceUP) or control condition. The effect of the treatment on changes on primary outcome mental well-being (PHQ ADS), and secondary outcomes (psychosomatic symptoms, stress, headache-related self-efficacy, intention to change behavior, presentism and absenteeism, pain coping) were assessed using Linear Mixed Models and Cohen d. Primary and secondary outcomes were assessed pre- and post-intervention, engagement during and acceptance post-intervention.

Results:

A total of 198 participants (mean age 38.7, SD 12.14; 86.9% women) were recruited online and in collaboration with experts and allocated to the intervention (n=110), and control group (n=88). Post-intervention, the intention to threat (ITT) analysis revealed very strong evidence for improved well-being (treatment: est/beta –3.28, 95% CI –5.07 to –1.48) with moderate between-group effects (Cohen d=–0.66, 95% CI –0.99 to –0.33) in favor of the intervention group. We also found strong evidence for reduced somatic symptoms, perceived stress, absenteeism/presentism, as well as improved headache management self-efficacy, application of behavior change techniques, and pain coping skills, with effects ranging from medium to large (d=0.43 to d=1.05). 65% of participants used the coaching as intended by engaging throughout the coaching and completing the outro.

Conclusions:

BalanceUP was well accepted, results suggest that a coaching delivered by a CA can be effective in reducing headache sufferers’ burden by improving their well-being. Clinical Trial: German Clinical Trials Register DRKS00017422; https://trialsearch.who.int/Trial2.aspx?TrialID=DRKS00017422, Swiss Ethics BASEC-Nr. Req-2021-01365