JMIR Publications

ABSTRACT

Background:

Primary headaches, including migraine and tension-type headaches (TTH), are widespread, and have a social, physical, mental, and economic impact. Among 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 has three aims. First, 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. Second, to evaluate its effectiveness by comparing the intervention and wait-list control groups. Third, to assess the engagement and acceptance of participants using BalanceUP.

Methods:

In a unblinded randomized controlled trial, adults with frequent headaches were were recruited online and in collaboration with experts and allocated to either a CA intervention (BalanceUP) or control condition. The effect of the treatment on changes in 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 analyzed using Linear Mixed Models and Cohen d. Primary and secondary outcomes were self-assessed pre- and post-intervention, and acceptance post-intervention. Engagement was measured during the intervention by self-report and via usage data.

Results:

A total of 198 participants (mean age 38.7, SD 12.14; 86.9% women) participated in the study (intervention n=110, wait-list control group n=88). Post-intervention, the intention to threat (ITT) analysis revealed 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 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). In all, 65% of participants used the coaching as intended by engaging throughout the coaching and completing the outro.

Conclusions:

BalanceUP was well accepted, and 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