Group Cognitive Behavioural Therapy for Adults With Cystic Fibrosis

NCT06645782 | Completed

• 1 other identifier: 2024-644
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Cystic Fibrosis (CF)

Keywords

Cystic Fibrosis; Cognitive Behavioural Therapy; Group Therapy; Mental Health; Internet

Outcome Measures

Primary Outcomes (3)

• Acceptability of virtual group CF-CBT.

  Determined by rates of program completion and program satisfaction.

  From recruitment to completion of treatment (8 weeks).

• Feasibility of virtual, group CF-CBT.

  Determined by rates of participants recruitment (i.e., how many are interested, enroll) and rates of attendance.

  From recruitment to completion of treatment (8 weeks).

• Participant scores on the Client Satisfaction Questionnaire (CSQ) at the end of 8 week treatment.

  The CSQ measures satisfaction with a received service on an 8-item scale with items reflecting how satisfied the individual was with the service they completed. Total scores can range from a minimum score of 8 to a maximum score of 32.

  Post-intervention (8 weeks)

Secondary Outcomes (2)

• Change from baseline in the Patient Health Questionnaire-9 (PHQ-9) at the end of 8 week treatment.

  Baseline and post-intervention (8 weeks)

• Change from baseline in the Generalized Anxiety Disorder-7 (GAD-7) at the end of 8 week treatment.

  Baseline and post-intervention (8 weeks)

Other Outcomes (4)

• Change from baseline in the Perceived Stress Scale (PSS) at the end of 8 week treatment.

  Baseline and post-intervention (8 weeks)

• Change from baseline in the CF coping self-efficacy scale (CF-CSE) at the end of 8 week treatment.

  Baseline and post-intervention (8 weeks)

• Change from baseline in the Cystic Fibrosis Questionnaire - Revised (CFQ-R) at the end of 8 week treatment.

  Baseline and post-intervention (8 weeks)

Study Arms (1)

Virtual, group CF-CBT

EXPERIMENTAL

Behavioral: Virtual, Group CF-CBT

Interventions

Virtual, Group CF-CBT BEHAVIORAL

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.

Virtual, group CF-CBT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age.
• Must speak and read in English.
• Must have depression and/or anxiety scores in the mild to moderate range (as per the PHQ-9 and GAD-7) prior to study baseline.

You may not qualify if:

• Those with suicidal intent (either with or without a plan).

Sponsors & Collaborators

• University of Regina: lead

Study Sites (2)

St. Paul Hospital

Vancouver, British Columbia, Canada

Location

Royal Jubilee Hospital

Victoria, British Columbia, Canada

Location

MeSH Terms

Conditions

Cystic Fibrosis; Psychological Well-Being

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Personal Satisfaction; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: October 17, 2024
• Study Start: October 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

CA (2)