JMIR Publications

ABSTRACT

Background:

Fibromyalgia syndrome (FMS) is a chronic condition of widespread pain, fatigue, sleep disturbance and cognitive difficulty, for which guideline-recommended care centres on non-pharmacological, self-management approaches such as cognitive behavioural therapy (CBT), acceptance and commitment therapy (ACT) and physical activity. Access to these therapies is limited, and digital therapeutics (DTx) may help bridge this gap. dovalin is a 90-day DTx for adults with FMS, developed in accordance with the requirements for German digital health applications (DiGA) and combining CBT, ACT and lifestyle interventions with guided self-monitoring.

Objective:

To evaluate the acceptability and usability of dovalin in its intended population, prior to confirmatory efficacy testing, and to identify concrete directions for product refinement.

Methods:

We conducted a mixed-methods patient experience study. Adults with an FMS diagnosis were recruited online via targeted advertising, completed a baseline survey, used dovalin over an 8-week observation window, and completed a structured post-use feedback survey combining closed usability and acceptability ratings with extensive open-ended questions. Engagement was captured from usage logs. Closed items were summarised descriptively; free-text responses were analysed using a reflexive thematic analysis.

Results:

Thirty-five adults were enrolled (mean age 54 years; 34/35 women). Two withdrew and three were lost to follow-up; of the returned post-use surveys, 29 provided adequate data and formed the analysis sample. Engagement was substantial, with registered users (n=33) completing a mean (SD) of 5.8/9 (3.0) conversations. Closed-item ratings were favourable, with 83% (24/29) of patients rating dovalin as helpful and 75% (21/28) indicating that they would recommend the programme. Reflexive thematic analysis yielded eight themes. Participants valued feeling understood and less alone, reported concrete behaviour change (sleep, movement, relaxation), and praised the relaxation/audio exercises, movement content and psychoeducation. Feedback suggested that some patients with long disease experiences perceived the content as being pitched primarily at the newly diagnosed, that some of the pre-set response options did not always fit individual preferences, and that some patients would have liked the option of going back in the simulated conversations at the core of the programme.

Conclusions:

Participants engaged substantially with dovalin, rated the programme favourably, expressed a strong willingness to recommend it, and described relevant self-management benefits. Their feedback identified targeted opportunities for refinement, particularly clearer signposting of existing flexible options, reduced navigation and access friction, and stronger tailoring to users’ prior experiences and pre-existing knowledge. These findings support further optimisation of dovalin and progression to a randomised controlled trial.