Pilot Testing in the Wild: Feasibility, Acceptability, Usage Patterns, and Efficacy of an Integrated Web and...

Bipolar II disorder (BD-II) is associated with significant burden, disability, and mortality; however, there continues to be a dearth of evidence-based psychological interventions for this condition. Technology-mediated interventions incorporating self-management have untapped potential to help meet this need as an adjunct to usual clinical care.

The objective of this pilot study is to assess the feasibility, acceptability, and clinical utility of a novel intervention for BD-II (Tailored Recovery-oriented Intervention for Bipolar II Experiences; TRIBE), in which mindfulness-based psychological content is delivered via an integrated web and smartphone platform. The focus of the study is evaluation of the dynamic use patterns emerging from ecological momentary assessment and intervention to assist the real-world application of mindfulness skills learned from web-delivered modules.

An open trial design using pretest and posttest assessments with nested qualitative evaluation was used. Individuals (aged 18-65 years) with a diagnosis of BD-II were recruited worldwide and invited to use a prototype of the TRIBE intervention over a 3-week period. Data were collected via web-based questionnaires and phone interviews at baseline and 3-week follow-up.

A total of 25 participants completed baseline and follow-up assessments. Adherence rates (daily app use) were 65.6% across the 3-week study, with up to 88% (22/25) of participants using the app synergistically alongside the web-based program. Despite technical challenges with the prototype intervention (from user, hardware, and software standpoints), acceptability was adequate, and most participants rated the intervention positively in terms of concept (companion app with website: 19/25, 76%), content (19/25, 76%), and credibility and utility in supporting their management of bipolar disorder (17/25, 68%). Evaluation using behavioral archetypes identified important use pathways and a provisional model to inform platform refinement. As hypothesized, depression scores significantly decreased after the intervention (Montgomery-Asberg Depression Rating Scale baseline mean 8.60, SD 6.86, vs follow-up mean 6.16, SD 5.11; t₂₄=2.63; P=.01; Cohen d=0.53, 95% CI 0.52-4.36).

Our findings suggest that TRIBE is feasible and represents an appropriate and acceptable self-management program for patients with BD-II. Preliminary efficacy results are promising and support full development of TRIBE informed by the present behavioral archetype analysis. Modifications suggested by the pilot study include increasing the duration of the intervention and increasing technical support.