Cognitive Behavioural Therapy for Cystic Fibrosis

Enrolling by invitation at 1 trial location

Overseen By Anna Dollimount, M.Sc.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Regina

Disqualifiers: Suicidal intent

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mental health program called CF-CBT (Cognitive Behavioural Therapy), specifically designed for individuals with cystic fibrosis (CF). The researchers aim to determine if participating in this therapy online in a group setting can reduce depression and anxiety, lower stress, improve coping skills, and enhance overall quality of life. The trial seeks adults with CF who experience mild to moderate depression or anxiety. Participants will engage in the online program for eight weeks and provide feedback through surveys and interviews. The goal is to assess the effectiveness and user-friendliness of this virtual therapy for individuals with CF. As an unphased trial, this study offers participants the chance to contribute to innovative research that could improve mental health support for the CF community.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on therapy rather than medication changes.

What prior data suggests that this virtual, group CF-CBT is safe for adults with cystic fibrosis?

Research has shown that virtual group Cognitive Behavioral Therapy (CF-CBT) is generally safe for people with cystic fibrosis (CF). Studies have found that similar online therapy programs are well-received, with most participants completing the program and feeling satisfied. This suggests that people usually continue with the program and find it helpful.

In trials with CF patients, these therapy sessions aim to reduce anxiety and stress. Participants often report feeling better after completing the program, indicating its safety and effectiveness. No major negative effects have been reported, making this a promising option for mental health support in CF. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Virtual, Group CF-CBT for cystic fibrosis because it addresses the mental health challenges that often accompany this chronic condition in a novel way. Traditional treatments for cystic fibrosis focus on physical symptoms and include medications like antibiotics and airway clearance techniques. However, this new approach uses Cognitive Behavioral Therapy (CBT) in a virtual group setting, making mental health support more accessible and convenient for patients. This method offers the potential to improve quality of life and emotional well-being without the need for in-person therapy sessions, which can be difficult for patients with limited mobility or those living far from specialized care centers.

What evidence suggests that virtual, group CF-CBT is effective for reducing depression and anxiety in adults with cystic fibrosis?

Research has shown that Cognitive Behavioural Therapy (CBT) effectively reduces symptoms of depression and anxiety. In this trial, participants will receive virtual, group CF-CBT, specifically designed for individuals with cystic fibrosis to address these issues. Previous studies have found that online CBT increases accessibility to mental health care and is practical and well-received, with few participants dropping out. A small study on a similar online program demonstrated its effectiveness in managing stress in people with cystic fibrosis. This suggests that virtual, group CF-CBT might improve mental health and quality of life for adults with cystic fibrosis. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with Cystic Fibrosis who are comfortable using virtual platforms. Participants should be willing to complete questionnaires and engage in an online mental health program over eight weeks. There's no specific mention of exclusion criteria provided.

Inclusion Criteria

Must speak and read in English

My depression or anxiety is mild to moderate according to recent tests.

Exclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants complete the CF-CBT online mental health program over eight weeks

8 weeks

8 virtual sessions

Follow-up

Participants are monitored for changes in depression, anxiety, perceived stress, coping skills, and health-related quality of life

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Virtual, Group CF-CBT

Trial Overview The trial tests a group Cognitive Behavioural Therapy (CF-CBT) delivered virtually over eight weeks, aiming to reduce depression, anxiety, stress, improve coping skills and quality of life in adults with CF. It will compare the results with individual CF-CBT outcomes.

How Is the Trial Designed?

Group I: Virtual, group CF-CBT Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Regina

Lead Sponsor

Trials

59

Recruited

9,100+

Published Research Related to This Trial

The CF-specific cognitive-behavioral therapy (CF-CBT) was found to be feasible and acceptable for adults with mild depression and/or anxiety, with high engagement and treatment fidelity during the 8-session program involving 14 participants.

Preliminary effectiveness results showed significant improvements in depressive symptoms and quality of life, particularly in vitality and relaxation skills, suggesting that CF-CBT could be a valuable addition to integrated care for cystic fibrosis patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of a CF-specific cognitive-behavioral preventive intervention for adults integrated into team-based care. Friedman, D., Smith, BA., Bruce, A., et al.[2022]

The eHealth CF-CBT program, a digital mental health intervention for adults with cystic fibrosis, showed high feasibility and acceptability, with all 10 participants completing the 8-session program successfully.

Preliminary results indicated significant improvements in anxiety (90% of participants), depression (90% of participants), and perceived stress (80% of participants), suggesting that this intervention could be effective for managing mental health in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot of a therapist-guided digital mental health intervention (eHealth CF-CBT) for adults with cystic fibrosis. Verkleij, M., Georgiopoulos, AM., Barendrecht, H., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06645782

Group Cognitive Behavioural Therapy for Adults With Cystic ... Virtual, group CF-CBT will be feasible and acceptable, as indexed by low rates of drop out and high rates of adherence and satisfaction. · There will be ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8010637/

Development and evaluation of an internet-based cognitive ... A CF-specific internet-based cognitive-behavioral therapy (CBT) intervention was developed to increase access to evidence-based mental health care.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1569199321013266

Pilot RCT of a telehealth intervention to reduce symptoms ... This study fills that void by providing crucial pilot data on the effectiveness of CALM, a CF-specific, manualized cognitive behavioral stress management ...

4. trial.medpath.com trial.medpath.com/clinical-trial/bcea1721cb52bc1e/nct06645782-virtual-cystic-fibrosis-therapy-adults

Group Cognitive Behavioural Therapy for Adults With Cystic ... Primary outcomes will be compared to benchmark study of individual CF-CBT. Secondary outcomes (i.e., depression, anxiety) will be compared against themselves ( ...

5. withpower.com withpower.com/trial/phase-fibrosis-9-2024-6fd5d

Cognitive Behavioural Therapy for Cystic Fibrosis Virtual, Group CF-CBT is unique because it is a digital mental health intervention specifically designed for people with cystic fibrosis to address anxiety and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11815457/

Psychosocial and mental health in cystic fibrosis in the ... CF-specific online cognitive behavioural therapy group mental health intervention revised from epilepsy programme to reduce anxiety and ...

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/ppul.26101

Feasibility and acceptability of a CF‐specific cognitive‐ ... Mental health outcomes included depression, anxiety, quality of life (Cystic Fibrosis Questionnaire-Revised [CFQ-R), perceived stress and coping. Preliminary ...