Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06645782
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-11
Brief Title:
Group Cognitive Behavioural Therapy for Adults with Cystic Fibrosis
Sponsor:
None
Organization:
None
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie 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 tertiaryother 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 ie depression anxiety will be compared against themselves ie pre- and post-group Tertiaryother outcomes ie perceived stress coping skills health related quality of life will be compared against themselves ie pre- and post-group The associations between self-reported outcome measures and group cohesion will be analyzed by computing Pearson correlation coefficients
The primary research questions is
How feasible and acceptable ie 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 tertiaryother 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 ie depression anxiety will be compared against themselves ie pre- and post-group Tertiaryother outcomes ie perceived stress coping skills health related quality of life will be compared against themselves ie 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 70000 to 100000 patients worldwide Cystic Fibrosis Canada 2018 Cystic Fibrosis Worldwide nd 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 eg 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 eg 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 ie 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 GPower 31 was used to calculate the study sample size based upon on secondary analyses ie t-test Assuming 80 power an alpha of 005 and an effect size of 05 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 21 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
Tertiaryother 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
METHODSPROCEDURES Participants with mild-moderate anxiety andor 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 participantsgroup 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 ie enrollment and attrition and measure total scores will be reported ie 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 Cohens d metric of effect sizes ES of pre-post mean change scores will be used to assess the magnitude of the effects Tertiaryother analyses Tertiaryother outcomes will be analyzed using paired t-tests Cohens 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
PARTICIPANTS GPower 31 was used to calculate the study sample size based upon on secondary analyses ie t-test Assuming 80 power an alpha of 005 and an effect size of 05 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 21 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
Tertiaryother 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
METHODSPROCEDURES Participants with mild-moderate anxiety andor 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 participantsgroup 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 ie enrollment and attrition and measure total scores will be reported ie 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 Cohens d metric of effect sizes ES of pre-post mean change scores will be used to assess the magnitude of the effects Tertiaryother analyses Tertiaryother outcomes will be analyzed using paired t-tests Cohens 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None