MukoHelp: A self-help manual for patients with cystic fibrosis-Results from a randomized controlled trial

There is a high prevalence of anxiety and depression in patients with cystic fibrosis (CF) but only a few interventions tailored to their needs. To date, no effective CF-specific self-help interventions exist, even though such interventions have the potential to overcome treatment barriers. This randomized controlled trial evaluated the acceptance and efficacy of MukoHelp, the first unguided self-help intervention in patients with self-reported CF.

Participants (N = 82) were randomized to either the MukoHelp group (n = 41) or a waitlist control group (n = 41). Patients were assessed before (baseline), after the six-week intervention period (post), and three months after post (follow-up). Assessments included acceptability (Client Satisfaction Questionnaire; CSQ), efficacy (e.g., anxiety; Generalized Anxiety Disorder-7 Scale; GAD-7), and adherence.

MukoHelp received mixed acceptability with a high acceptance according to the CSQ (75.7%), but adherence was low, indicating low acceptability. The intervention did not lead to significant improvements in symptoms of anxiety compared to waitlist controls (p = .645, η_p² = 0.005). Exploratory analyses suggest that low adherence impacted efficacy as the item "I apply what I have learned in the MukoHelp chapters in my everyday life" was negatively correlated at a moderate effect size with the GAD-7 baseline-post difference score (r = -0.500, p = .035).

While some participants reported satisfaction, overall engagement and adherence were low, and no symptom improvements were observed. This suggests that future versions of MukoHelp should focus on increasing sustained usage-potentially through added guidance or supportive elements-to enhance feasibility and therapeutic impact.