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ENROLLING BY INVITATION
NCT06645782
NA

Group Cognitive Behavioural Therapy for Adults With Cystic Fibrosis

Sponsor: University of Regina

View on ClinicalTrials.gov

Summary

The overall goal of this clinical trial is to: a) explore the feasibility, acceptability, and participant experiences with the group version of CF-CBT; b) examine the effectiveness of the virtual delivery of a group version of CF-CBT in reducing depression and anxiety symptoms, perceived stress, coping skills, and health related quality of life among adults with CF. The primary research questions is: • How feasible and acceptable (i.e., drop out, adherence, and satisfaction) is virtual, group CF-CBT? The secondary research questions is: • How will virtual, group CF-CBT affect depression and anxiety? The tertiary/other research questions are: * How will virtual, group CF-CBT affect perceived stress, coping skills, and health related quality of life? * What is the association between group cohesion and depression, anxiety, perceived stress, coping skills, and health related quality of life? Participants will: * Complete short demographic questionnaire regarding their personal and health information. * Complete questionnaires about symptoms of depression, anxiety, perceived stress, coping skills, and health related quality of life at pre- and post-program. An additional measure of treatment expectancy will be completed at pre-program only. At post-program only, measures of group cohesion and treatment satisfaction will be completed. * Complete the CF-CBT online mental health program over eight weeks. * Be invited to complete an interview about their experiences with the program. Primary outcomes will be compared to benchmark study of individual CF-CBT. Secondary outcomes (i.e., depression, anxiety) will be compared against themselves (i.e., pre- and post-group). Tertiary/other outcomes (i.e., perceived stress, coping skills, health related quality of life) will be compared against themselves (i.e., pre- and post-group). The associations between self-reported outcome measures and group cohesion will be analyzed by computing Pearson correlation coefficients.

Official title: Virtual, Group Adaptation of a Cystic Fibrosis (CF) Specific Cognitive Behavioural Therapy for Adults With CF: An Exploration of Effectiveness, Feasibility, and Participant Experiences.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

27

Start Date

2024-10-01

Completion Date

2025-08

Last Updated

2025-04-04

Healthy Volunteers

No

Interventions

BEHAVIORAL

Virtual, Group CF-CBT

Virtual, group CF-CBT is an online, tailored CBT program for adults diagnosed with CF. Participants will attend eight weekly sessions (90 minutes each) delivered online. The sessions include: Introduction to CBT; Relaxation Skills; Depression in CF: What Helps?; Adaptive Thinking Skills, Part 1; Adaptive Thinking Skills, Part 2; Taking Charge of My Health; Anxiety in CF: What Helps?; and Maintaining Positive Changes.

Locations (2)

St. Paul Hospital

Vancouver, British Columbia, Canada

Royal Jubilee Hospital

Victoria, British Columbia, Canada