27 Participants Needed

Cognitive Behavioural Therapy for Cystic Fibrosis

Recruiting at 1 trial location
KW
AD
Overseen ByAnna Dollimount, M.Sc.
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Regina
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Virtual, Group CF-CBT for cystic fibrosis?

Research shows that a digital mental health intervention called eHealth CF-CBT, which is similar to Virtual, Group CF-CBT, is highly acceptable and usable for adults with cystic fibrosis. Additionally, cognitive-behavioral therapy (CBT) is well-established for treating anxiety and depression, which are common in cystic fibrosis, suggesting that a CF-specific CBT could be effective in improving mental health for these patients.12345

Is Cognitive Behavioral Therapy safe for people with cystic fibrosis?

Cognitive Behavioral Therapy (CBT) for cystic fibrosis, including digital and group formats, has been developed with input from the CF community and has shown high acceptability and usability, indicating it is generally safe for use in humans.12356

How is the Virtual, Group CF-CBT treatment different from other treatments 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 depression. It is delivered online, making it more accessible and reducing the cost and burden of care compared to traditional face-to-face therapy.12347

Eligibility Criteria

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

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

Treatment Details

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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Virtual, group CF-CBTExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Regina

Lead Sponsor

Trials
59
Recruited
9,100+

Findings from Research

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.
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]
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.
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]

References

Pilot of a therapist-guided digital mental health intervention (eHealth CF-CBT) for adults with cystic fibrosis. [2023]
Feasibility and acceptability of a CF-specific cognitive-behavioral preventive intervention for adults integrated into team-based care. [2022]
Development and evaluation of an internet-based cognitive behavioral therapy intervention for anxiety and depression in adults with cystic fibrosis (eHealth CF-CBT): An international collaboration. [2022]
ACT with CF: A telehealth and in-person feasibility study to address anxiety and depressive symptoms among people with cystic fibrosis. [2021]
Patient engagement in the development of CF-CBT: A cystic fibrosis-specific cognitive-behavioral intervention for adults. [2022]
Anxiety and depression in cystic fibrosis. [2009]
Fatigue In Teenagers on the interNET--the FITNET Trial. A randomized clinical trial of web-based cognitive behavioural therapy for adolescents with chronic fatigue syndrome: study protocol. [ISRCTN59878666]. [2022]
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