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ongoing trials trial from www.clinicaltrials.gov

Preventing Depression and Anxiety: A Cystic Fibrosis-Specific Cognitive Behavioral Therapy Intervention - Recruiting

  • Year: 2019
  • Date: July 22, 2019
  • Author: Massachusetts General Hospital|Cystic Fibrosis Foundation|DeltaQuest Foundation, Inc.|University at Buffalo|University of Kansas Medical Center|Stanford University|Nicklaus Children's Hospital f/k/a Miami Children's Hospital
Source

https://ClinicalTrials.gov/show/NCT03992027

Study design (if review, criteria of inclusion for studies)

Interventional - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Prevention

Participants

Depression|Anxiety - 18 Years and older   (Adult, Older Adult)

Interventions

Behavioral: CF-CBT: A Cognitive-Behavioral Skills-Based Program to Promote Emotional Well-Being for Adults wtih Cystic Fibrosis|Behavioral: Waitlist Control

Outcome measures

Change from baseline in Depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9)|Change from baseline in Anxiety symptoms measured by the Generalized Anxiety Disorder-7 item scale (GAD-7)|Treatment acceptability as measured by item and total score summation on the Client Satisfaction Questionnaire (CSQ-8) with additional study-specific items|Change from baseline in Perceived Stress measured by the Perceived Stress Scale (PSS)|Change from baseline in Cystic Fibrosis Health-Related Quality of Life measured by the adult/teen version of the Cystic Fibrosis Questionnaire-Revised (CFQ-R).|Change from baseline in Coping Self-Efficacy measured by the CF Coping Self-Efficacy Measure developed for this study|Feasibility of the intervention will be indicated by Rate of Attrition, or rate of drop-out or non-completion of the CF-CBT program once enrolled|Feasibility of the intervention will also be indicated by Treatment Fidelity, measured as percent adherence to general and CF-CBT session-specific objectives.

Keywords: Adult; Caregivers; Child; non pharmacological intervention - psyco-soc-edu-org; Psychoeducation; training; Depression; Systemic interventions; Mental Disease-Psychiatric Conditions; Behavioural interventions;