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

BACKGROUND

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.

METHODS

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.

RESULTS

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, ηp2 = 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).

CONCLUSIONS

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.