A randomized controlled trial of self-help cognitive behavioural therapy for depression in adults with pulmonary hypertension.

OBJECTIVES

Pulmonary hypertension (PH) is a progressive, life-reducing group of conditions associated with an elevated risk of depression. To meet this clinical need, we developed an unguided self-help intervention targeting depression in PH based on cognitive behavioural therapy (CBT) and tested its acceptability, feasibility, and effectiveness.

DESIGN

A randomized controlled trial (RCT) design was utilized with a wait-list control group. Acceptability was assessed using content analysis.

METHODS

Adults self-reporting difficulties with depression were recruited from global Pulmonary Hypertension Associations. Participants were randomly assigned to the intervention (n = 33) or the wait-list control group (n = 35). Depression was the primary outcome; secondary outcomes included anxiety, health-related quality of life, pain self-efficacy, fatigue, and cognitions and behaviours associated with mood difficulties. Change from baseline to post-intervention (4 weeks) and follow-up (1 month later) was measured.

RESULTS

We found a significant reduction in depression and HRQoL in the intervention group compared with the control group, with medium effect sizes. No significant changes were observed in other outcomes (p > .05). Overall, 72% of individuals in the treatment arm scored above the clinical level of depression, compared with 28% at post-intervention and 36% at follow-up. The intervention was judged to be acceptable and feasible, with the main benefits including tools to support, increased motivation, and understanding of depression. No adverse events were reported. Change in cognitions and behaviours did not mediate the relationship between the intervention group and change in depression (p > .05).

CONCLUSIONS

Results support the use of CBT for depression in PH and provide evidence for the delivery of self-help at scale via PHA-UK, the UK's leading charity for PH.