Back to resultsPilot Study of a CF-specific CBT Intervention for Adolescents
Primary Purpose
Cystic Fibrosis, Depression, Anxiety
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy (CBT)
Sponsored by
About this trial
This is an interventional treatment trial for Cystic Fibrosis
Eligibility Criteria
Inclusion Criteria:
- Be 12-17 years of age
- Have a diagnosis of CF
- 3. Have depression symptom scores on the PHQ-A in the mild to moderately severe range (> 4 and ≤ 19), but not in the severe range, and/or anxiety scores on the GAD-7 from mild to severe range (5 to 21).
- Be able to speak and read English
- Be willing and able to provide assent
- Have a parent who is willing and able to provide informed consent for their own and adolescent participation
- Have a parent who is able to speak and read English; the parent will participate in the study in support of their adolescent during the intervention and complete pre- and post- assessments.
Subjects will not be excluded for the following reasons:
- CF severity or lung/liver transplant status, if they are otherwise able to participate in CBT. If subjects are medically hospitalized during the course of the study, they may continue to participate in the CBT intervention or follow up visits during or following hospitalization as clinically appropriate.
- A history of more severe depression currently at mild to moderate levels with or without treatment.
- Participation in concomitant psychosocial treatments (with the exception of formal CBT) or psychopharmacologic treatments at baseline, although these concomitant treatments will be tracked and considered in analysis.
Exclusion criteria:
1. Any subjects who are deemed to present an acute safety risk to self or others will be excluded. Subjects reporting a positive answer on question 9 on the PHQ-9, dealing with suicidality, will be further assessed for severity and clinical context, including administration of the Columbia Suicide Severity Rating Scale (C-SSRS, Screen Version, Recent; Posner, 2011). Those reporting suicidal intent with or without specific plan (yes to question 4 and/or 5 on the C-SSRS) will be excluded from the study. These individuals will be referred for urgent/emergent further assessment and treatment as clinically indicated.
2) Participation in concomitant formal cognitive-behavioral therapy at baseline
Sites / Locations
- University of Kansas Medical CenterRecruiting
- Massachusetts General HospitalRecruiting
- University at Buffalo
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CF-CBT-A intervention
Arm Description
Participants will meet with a therapist, a mental health provider on their cystic fibrosis care team who has received training in CF-CBT-A, for a baseline interview and introduction plus 9 weekly sessions of CF-CBT-A.
Outcomes
Primary Outcome Measures
Treatment acceptability as measured by item and total score summation on the Client Satisfaction Questionnaire (CSQ-8) with additional study-specific items
TThe Client Satisfaction Questionnaire (CSQ-8) is an 8-item self-report measure that assesses patient service satisfaction,rated on a 4-point scale from 1=lowest to 4=highest satisfaction. Post-intervention treatment satisfaction will also be assessed with a series of structured and open-ended questions specific to the study intervention. Completed by parent and adolescent. Assessed one time immediately post-intervention.
Feasibility of the intervention will be indicated by Rate of completion of the CF-CBT-A program sessions once enrolled
Rate of complete will be summarized by calculating the percentage of CF-CBT-A sessions completed by participants over the course of the study period.
Secondary Outcome Measures
Change from baseline in Depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9) - adolescent version
The PHQ-9 consists of nine questions measuring frequency of depressive symptoms, rated on a Likert scale from 0 "not at all" to 3 "nearly every day," with total score ranging 0-27. Clinical severity scores have been established with scores of 5, 10, 15, and 20 representing cut-off scores for mild, moderate, moderately severe, and severe depression, respectively.
Change from baseline in Anxiety symptoms measured by the Generalized Anxiety Disorder-7 item scale (GAD-7)
The GAD-7 is a 7-item measure of symptoms of anxiety. Likert scale ratings allow total scores of 0-21. Scores of 5, 10, and 15 correspond to severity ratings of mild, moderate and severe anxiety.
Change in Perceived Stress, measured by the PROMIS Pediatric and Parent Proxy Psychological Stress Experiences 8-item short forms
This measure assesses psychological stress reactions (e.g., feeling overwhelmed, perceived lack of control of capacity to manage one's life).5Adolescents will self-report and parents will complete the proxy report about their child, providing another perspective on adolescent adjustment. Both scales use a 7-day recall period and include 8 items rated on a 5-point Likert Scale from "Never" to "Always," (e.g., In the past 7 days, I felt stressed).
Change in Health-Related Quality of Life, measured by the Cystic Fibrosis Questionnaire-Revised (CFQ-R)
The CFQ-R is a well-established measure of HRQoL, validated in a national, multicenter longitudinal study, and demonstrating consistent associations with health outcomes. A parent proxy version will be administered for adolescent participants ages 12 and 13.
Change in Coping Self-Efficacy, measured by the CF Coping Self-Efficacy Scale - adolescent version
A self-report measure of confidence in being able to cope with the daily challenges associated with CF developed with input of people with CF. Confidence in being able to use coping skills targeted by the intervention, including those specific to coping with CF, are rated on a 10-point scale from 'very sure' to 'very unsure'.
Full Information
NCT ID
NCT05271643
First Posted
February 28, 2022
Last Updated
July 21, 2023
Sponsor
Massachusetts General Hospital
Collaborators
University at Buffalo, University of Kansas Medical Center, Behavioral Health Systems Research
1. Study Identification
Unique Protocol Identification Number
NCT05271643
Brief Title
Pilot Study of a CF-specific CBT Intervention for Adolescents
Official Title
Preventing Depression and Anxiety: a Pilot Study of a Cystic-fibrosis Specific Cognitive-behavioral Therapy Intervention for Adolescents With CF
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 2, 2022 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
University at Buffalo, University of Kansas Medical Center, Behavioral Health Systems Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The goal of this study is to pilot a new CF-specific cognitive-behavioral therapy intervention (CF-CBT-A) for prevention and treatment of depression and anxiety for adolescents with CF. CF-CBT-A is a 10-session program that was developed with input from adolescents with CF and parents and CF care teams to be highly relevant to the unique needs of adolescents with CF. The program will be piloted at 3 U.S. CF centers with 10 to 12 adolescents with cystic fibrosis who have mild to moderately severe symptoms of depression and/or mild to severe symptoms of anxiety. It will be delivered by mental health coordinator members of the participant's CF care team who receive training, with sessions occurring in-person or via telehealth. We will examine feasibility and acceptability of the intervention as indicated by measures of completion, intervention fidelity, and adolescent and parent satisfaction ratings. We will also examine preliminary evidence of effectiveness. If this intervention is successful, symptoms of depression and anxiety and perceived psychological stress will decrease and coping self-efficacy and health-related quality of life (HRQoL) will improve.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis, Depression, Anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CF-CBT-A intervention
Arm Type
Experimental
Arm Description
Participants will meet with a therapist, a mental health provider on their cystic fibrosis care team who has received training in CF-CBT-A, for a baseline interview and introduction plus 9 weekly sessions of CF-CBT-A.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy (CBT)
Intervention Description
CF-CBT-A is an 10-session program for adolescents with cystic fibrosis introducing cognitive-behavioral coping skills for managing stress, and for prevention and treatment of anxiety and depression. The content of the program was developed to address stressors related to coping with cystic fibrosis. Participants will receive a patient workbook, and meet with a trained mental health clinician on their CF team who will guide them through learning and practicing coping skills. Parents/guardians involvement will be encouraged. A parent/guardian will attend the baseline and final session, have the opportunity for a mid-program check-in, and receive a workbook of psychoeducational material that parallels the adolescent workbook, featuring tips for supporting their teens, and weekly e-mail communication.
Primary Outcome Measure Information:
Title
Treatment acceptability as measured by item and total score summation on the Client Satisfaction Questionnaire (CSQ-8) with additional study-specific items
Description
TThe Client Satisfaction Questionnaire (CSQ-8) is an 8-item self-report measure that assesses patient service satisfaction,rated on a 4-point scale from 1=lowest to 4=highest satisfaction. Post-intervention treatment satisfaction will also be assessed with a series of structured and open-ended questions specific to the study intervention. Completed by parent and adolescent. Assessed one time immediately post-intervention.
Time Frame
immediately post-intervention
Title
Feasibility of the intervention will be indicated by Rate of completion of the CF-CBT-A program sessions once enrolled
Description
Rate of complete will be summarized by calculating the percentage of CF-CBT-A sessions completed by participants over the course of the study period.
Time Frame
From baseline to post-intervention (2-3 months)
Secondary Outcome Measure Information:
Title
Change from baseline in Depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9) - adolescent version
Description
The PHQ-9 consists of nine questions measuring frequency of depressive symptoms, rated on a Likert scale from 0 "not at all" to 3 "nearly every day," with total score ranging 0-27. Clinical severity scores have been established with scores of 5, 10, 15, and 20 representing cut-off scores for mild, moderate, moderately severe, and severe depression, respectively.
Time Frame
From baseline to post-intervention (2-3 months)
Title
Change from baseline in Anxiety symptoms measured by the Generalized Anxiety Disorder-7 item scale (GAD-7)
Description
The GAD-7 is a 7-item measure of symptoms of anxiety. Likert scale ratings allow total scores of 0-21. Scores of 5, 10, and 15 correspond to severity ratings of mild, moderate and severe anxiety.
Time Frame
From baseline to post-intervention (2-3 months)
Title
Change in Perceived Stress, measured by the PROMIS Pediatric and Parent Proxy Psychological Stress Experiences 8-item short forms
Description
This measure assesses psychological stress reactions (e.g., feeling overwhelmed, perceived lack of control of capacity to manage one's life).5Adolescents will self-report and parents will complete the proxy report about their child, providing another perspective on adolescent adjustment. Both scales use a 7-day recall period and include 8 items rated on a 5-point Likert Scale from "Never" to "Always," (e.g., In the past 7 days, I felt stressed).
Time Frame
From baseline to post-intervention (2-3 months)
Title
Change in Health-Related Quality of Life, measured by the Cystic Fibrosis Questionnaire-Revised (CFQ-R)
Description
The CFQ-R is a well-established measure of HRQoL, validated in a national, multicenter longitudinal study, and demonstrating consistent associations with health outcomes. A parent proxy version will be administered for adolescent participants ages 12 and 13.
Time Frame
From baseline to post-intervention (2-3 months)
Title
Change in Coping Self-Efficacy, measured by the CF Coping Self-Efficacy Scale - adolescent version
Description
A self-report measure of confidence in being able to cope with the daily challenges associated with CF developed with input of people with CF. Confidence in being able to use coping skills targeted by the intervention, including those specific to coping with CF, are rated on a 10-point scale from 'very sure' to 'very unsure'.
Time Frame
From baseline to post-intervention (2-3 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Be 12-17 years of age
Have a diagnosis of CF
3. Have depression symptom scores on the PHQ-A in the mild to moderately severe range (> 4 and ≤ 19), but not in the severe range, and/or anxiety scores on the GAD-7 from mild to severe range (5 to 21).
Be able to speak and read English
Be willing and able to provide assent
Have a parent who is willing and able to provide informed consent for their own and adolescent participation
Have a parent who is able to speak and read English; the parent will participate in the study in support of their adolescent during the intervention and complete pre- and post- assessments.
Subjects will not be excluded for the following reasons:
CF severity or lung/liver transplant status, if they are otherwise able to participate in CBT. If subjects are medically hospitalized during the course of the study, they may continue to participate in the CBT intervention or follow up visits during or following hospitalization as clinically appropriate.
A history of more severe depression currently at mild to moderate levels with or without treatment.
Participation in concomitant psychosocial treatments (with the exception of formal CBT) or psychopharmacologic treatments at baseline, although these concomitant treatments will be tracked and considered in analysis.
Exclusion criteria:
1. Any subjects who are deemed to present an acute safety risk to self or others will be excluded. Subjects reporting a positive answer on question 9 on the PHQ-9, dealing with suicidality, will be further assessed for severity and clinical context, including administration of the Columbia Suicide Severity Rating Scale (C-SSRS, Screen Version, Recent; Posner, 2011). Those reporting suicidal intent with or without specific plan (yes to question 4 and/or 5 on the C-SSRS) will be excluded from the study. These individuals will be referred for urgent/emergent further assessment and treatment as clinically indicated.
2) Participation in concomitant formal cognitive-behavioral therapy at baseline
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Deborah Friedman, PhD
Phone
617-724-8598
Email
dfriedman@mgh.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Anna M Georgiopoulos, MD
Phone
6176432330
Email
AGEORGIOPOULOS@PARTNERS.ORG
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah M Friedman, PhD
Organizational Affiliation
Massachusetts General Hospital (MGH)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anna M Georgiopoulos, MD
Organizational Affiliation
Massachusetts General Hospital (MGH)
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amanda Bruce, PhD
Email
abruce2@kumc.edu
First Name & Middle Initial & Last Name & Degree
Amanda Bruce, PhD
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deborah M Friedman, PhD
Phone
617-724-8598
Email
dfriedman@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Deborah Friedman, PhD
First Name & Middle Initial & Last Name & Degree
Anna M Georgiopoulos, MD
Facility Name
University at Buffalo
City
New York
State/Province
New York
ZIP/Postal Code
14260
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beth Smith, MD
Email
balucas@buffalo.edu
First Name & Middle Initial & Last Name & Degree
Beth Smith, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pilot Study of a CF-specific CBT Intervention for Adolescents
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