Clinical trial NCT06645782: Group Cognitive Behavioural Therapy for Adults With Cystic Fibrosis
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.
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Cystic Fibrosis (CF)
Keywords: Cystic Fibrosis
Cognitive Behavioural Therapy
Group Therapy
Mental Health
Internet
Lead sponsor: University of Regina
Sponsor class: OTHER
First posted: 2024-10-17
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: BACKGROUND: CF is a genetic, life-limiting, chronic disease that affects approximately 4300 Canadians (\~70,000 to 100,000 patients worldwide; Cystic Fibrosis Canada, 2018; Cystic Fibrosis Worldwide, n.d.; Sawicki et al., 2011). People with cystic fibrosis (pwCF) demonstrate high rates of depression and anxiety (Quittner et al., 2014) and the corresponding deleterious impact on functioning is alarming (e.g., decreased lung function and worse adherence to critical life prolonging therapies; Smith et al., 2010; Yohannes et al., 2012). While evidence-based psychological approaches for depression and anxiety, such as cognitive behavioral therapy (CBT), are effective in reducing depression and anxiety symptoms that are co-morbid with other chronic illnesses (e.g., diabetes, COPD, and cancer; Uchendu \& Blake, 2016; Williams et al., 2020; Shi et al., 2019; Gandy et al., 2013; López-López et al., 2019), there is a need to design tailored treatments to address the specialized needs of pwCF. To this end, Friedman, Georgiopoulos, and colleagues developed CF-CBT, an innovative, effective, 8-session, individually delivered CF-specific CBT-based intervention program to promote emotional well-being for adults with CF (Friedman et al., 2022a; Friedman et al., 2022b). Virtual delivery of CF-CBT in a group format is one way to address the potentially prohibitive costs of mental health treatment while also addressing infection control guidelines for pwCF, which preclude in-person groups (Saiman et al., 2014)). CF-CBT has been recently modified (i.e., session structure, activities) for group delivery; however, feasibility, acceptability, effectiveness of, and patient experiences with this mode of delivery have yet to be investigated.

PARTICIPANTS: G\*Power 3.1 was used to calculate the study sample size based upon on secondary analyses (i.e., t-test). Assuming 80% power, an alpha of 0.05, and an effect size of 0.5 (medium), a sample size of at least 27 participants would be needed. The investigation aims to recruit 28-30 participants to address attrition. Participants with CF will be recruited from CF clinics in British Columbia, Canada. Participants will be consecutively enrolled into groups upon completing pre-program measures. The investigators will seek to have a 2:1 women to men ratio to address gender variations in mental health symptoms and disorders.

HYPOTHESES:

Primary hypothesis:

1. Virtual, group CF-CBT will be feasible and acceptable, as indexed by low rates of drop out and high rates of adherence and satisfaction.

   Secondary hypothesis:
2. There will be significant improvements in self-reported depression and anxiety from pre- to post-program.

   Tertiary/other hypotheses:
3. There will be significant improvements in self-reported perceived stress, coping skills, and health related quality of life from pre- to post-program.
4. Self-reported group cohesion will be negatively associated with depression, anxiety, perceived stress, coping skills, and health related quality of life at post-program.

METHODS/PROCEDURES: Participants with mild-moderate anxiety and/or depression (as measured by the GAD-7 and PHQ-9) (as identified in routine mental health screeing in CF clinic) will be provided information on the study. Those interested in participating will have their email sent to the primary investigator (PI). The PI will email interested participants with a link to Qualtrics, containing the consent form, demographics form, and pre-program questionnaires to be completed before starting the program. Consecutively enrolled participants will be assigned to a virtual CF-CBT group (6-8 participants/group), with the group running for 90 minutes per week over eight weeks. Weekly sessions will be delivered virtually by two trained facilitators (clinical social workers) on the healthcare version of Zoom. Rates of participant enrollment and attrition will be recorded and a treatment fidelity checklist will be completed for 20% of sessions in real-time (by research assistant). Upon completion of the program, participants will be emailed by the PI with another Qualtrics link for the post-program questionnaires.

ANALYSES: Analyses will be completed using IBM SPSS Statistics-Version 26. Demographic and feasibility data (i.e., enrollment and attrition), and measure total scores will be reported (i.e., means and standard deviations for continuous data, frequencies and percentages for categorical data). Primary analyses: The primary outcomes will be compared to benchmark study of individual CF-CBT. Secondary analyses: Secondary outcomes will be analyzed using paired t-tests. Cohen's d metric of effect sizes (ES) of pre-post mean change scores will be used to assess the magnitude of the effects. Tertiary/other analyses: Tertiary/other outcomes will be analyzed using paired t-tests. Cohen's d metric of effect sizes (ES) of pre-post mean change scores will be used to assess the magnitude of the effects. The associations between self-reported outcome measures and group cohesion will be analyzed by computing Pearson correlation coefficients.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Acceptability of virtual group CF-CBT.
timeFrame: From recruitment to completion of treatment (8 weeks).
measure: Feasibility of virtual, group CF-CBT.
timeFrame: From recruitment to completion of treatment (8 weeks).
measure: Participant scores on the Client Satisfaction Questionnaire (CSQ) at the end of 8 week treatment.
timeFrame: Post-intervention (8 weeks)
Secondary outcomes:
measure: Change from baseline in the Patient Health Questionnaire-9 (PHQ-9) at the end of 8 week treatment.
timeFrame: Baseline and post-intervention (8 weeks)
measure: Change from baseline in the Generalized Anxiety Disorder-7 (GAD-7) at the end of 8 week treatment.
timeFrame: Baseline and post-intervention (8 weeks)
Other outcomes:
measure: Change from baseline in the Perceived Stress Scale (PSS) at the end of 8 week treatment.
timeFrame: Baseline and post-intervention (8 weeks)
measure: Change from baseline in the CF coping self-efficacy scale (CF-CSE) at the end of 8 week treatment.
timeFrame: Baseline and post-intervention (8 weeks)
measure: Change from baseline in the Cystic Fibrosis Questionnaire - Revised (CFQ-R) at the end of 8 week treatment.
timeFrame: Baseline and post-intervention (8 weeks)
measure: Participant scores on the Group Cohesion Scale - Revised (GCS-R) at the end of 8 week treatment.
timeFrame: Post-intervention (8 weeks)
Locations:
city: Vancouver
country: Canada
facility: St. Paul Hospital
state: British Columbia
city: Victoria
country: Canada
facility: Royal Jubilee Hospital
state: British Columbia
Study officials:
References: