ACT with CF: A randomized trial of acceptance and commitment therapy vs supportive psychotherapy for adults with cystic fibrosis.

Purpose: Psychological distress, including anxiety and depression, is common among adults with CF, associating with poor quality of life, lung function, and healthcare utilization. This 3-year, multi-site, telehealth-delivered randomized trial sought to determine whether Acceptance and Commitment Therapy (ACT with CF) is superior to supportive psychotherapy (SP), in improving psychological functioning for adults with CF.

Methods: One hundred twenty-four adults with CF and elevated anxiety and/or depressive symptoms were recruited coincident with the first COVID lockdown, from Thomas Jefferson University Hospitals, University of Virginia, Augusta University, Duke University Medical Center, and social media. Participants were randomized to 6 weeks of either ACT with CF or SP, delivered via Zoom. They completed measures of psychological functioning: depression (BDI-II), anxiety (BAI), cognitive fusion (CFQ-13), acceptance and committed action (AAQ-II); and barriers to adherence at baseline, post-treatment, and at 3-months follow-up. Biobehavioral outcomes, including CF severity and treatment burden, were gathered using EMR data.

Results: Participants were young adults (mean age 25 years [SD = 12]), female (75 %), on CFTR modulators (67 %), psychotropic medication(s) (60 %), with previous psychotherapy engagement (72 %). Treatment effects were evaluated using analysis of covariance, controlling for baseline levels of respective outcomes, age, biological sex, and FEV. ACT demonstrated greater improvements in psychological functioning at 6-weeks (mean score = 57.3 [51.6, 63.0]) relative to SP (mean score = 67.8 [62.2, 73.5], Cohen's d = 0.59, P = .017), with largest improvements in cognitive fusion (CFQ-13) and acceptance and committed action (AAQ-II). Treatment improvements in psychological functioning persisted at 3-months (ACT: 59.7 (53.5, 65.9) vs. SP: 69.0 [62.6, 75.4], Cohen's d = 0.40, P = .041), with ACT demonstrating continued improvements in the CFQ-13 and AAQ-II. Negative affect scores were not consistently improved on our mean-rank composite outcome variable (Cohen's d = 0.22, P = .170), despite post hoc reductions in BDI-II scores (ACT: -7.4 [-9.4, -5.4] vs. SP: -4.5 [-6.4, -2.6], P = .040). Improvements in psychological flexibility (CFQ-13 and AAQ-II) were also robustly associated with reductions in negative affect (B = -0.45, P < .001). Individuals in ACT with greater baseline barriers to medication adherence reported greater reductions in barriers after treatment (P = .026). Individuals with lower baseline FEV/FVC ratios (e.g. ≤ 65 %) demonstrating greater improvements in ACT compared with SP (ACT: 7.3 [1.7, 12.8] vs. SP: 1.3 [-3.2, 5.8], P = .036 for interaction).

Conclusions: ACT with CF was superior to SP in improving psychological functioning among adults with CF and elevated psychological distress, with additional benefits in secondary biobehavioral outcomes in a subset of individuals with greater medical burden. Improvements in psychological flexibility strongly associated with reductions in negative affect.

Clinicaltrials: gov ID #NCT04114227 Supported by the Boomer Esiason Foundation.