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Pilot RCT of a telehealth intervention to reduce symptoms of depression and anxiety in adults with cystic fibrosis

Published:August 05, 2021DOI:https://doi.org/10.1016/j.jcf.2021.07.012

      Highlights

      • Coping and Learning to Manage Stress (CALM) is a 6-session telehealth intervention.
      • Adults with CF (awCF) were randomized to CALM or treatment-as-usual (TAU).
      • After CALM, awCF had reduced symptoms of depression and anxiety compared to TAU.
      • After CALM, awCF improved coping and health-related quality of life compared to TAU.
      • CALM is a feasible, acceptable, and satisfactory therapeutic intervention.

      Abstract

      Background

      Adults with cystic fibrosis (awCF) have higher levels of depression and anxiety than community samples. The Coping and Learning to Manage Stress with CF (CALM) intervention was developed for awCF reporting elevated symptoms of depression or anxiety.

      Methods

      In this pilot study, awCF were randomly assigned to either six telehealth sessions (CALM; n = 15) or treatment-as-usual (TAU; n = 16). Primary outcomes were depression and anxiety. Secondary outcomes were coping self-efficacy and health-related quality of life (HrQOL). Tertiary outcomes were feasibility, acceptability, and satisfaction. Assessments were completed at baseline, post-intervention, and 3-month follow-up. Group differences were examined via independent samples t-tests. Effect size (ES) was calculated via Cohen's d to provide a measure of the magnitude of the treatment effect.

      Results

      At post-intervention, the CALM group had a lower mean score than the TAU group for depression (medium ES) and anxiety (large ES). The CALM group had higher (i.e., better) mean scores than the TAU group for coping (large ES) and HrQOL domains of Social Functioning (large ES) and Vitality (large ES). Most treatment gains were not sustained at 3-month follow-up. CALM was feasible, requiring <12 min. for setup and scheduling, and allowed seamless participation when hospitalized. Mean scores for acceptability and satisfaction indicated that most participants either agreed or strongly agreed that CALM was acceptable and satisfactory.

      Conclusions

      CALM shows promise as an intervention to reduce symptoms of depression and anxiety and improve coping and HrQOL. Next steps are to add a booster session and examine CALM via a multi-site RCT.

      Keywords

      Abbreviations:

      AwCF (adults with cystic fibrosis), CALM (coping and learning to manage stress with cystic fibrosis), CBSM (cognitive behavioral stress management), CBT (cognitive behavioral therapy), CSE (coping self-efficacy scale), ES (effect size), GAD-7 (generalized anxiety disorder 7-item scale), HrQOL (health-related quality of Life), MID (minimal important difference), PHQ-9 (patient health questionnaire 9-item scale), RCT (randomized controlled trial), TAU (treatment-as-usual)
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