Preventing Depression and Anxiety: a Pilot Study of a Cystic-fibrosis Specific Cognitive-behavioral Therapy Intervention for Adolescents With CF
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cystic Fibrosis
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 12
- Locations
- 3
- Primary Endpoint
- Feasibility of the intervention will be indicated by Rate of completion of the CF-CBT-A program sessions once enrolled
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Deborah Friedman
Assistant Professor of Psychology (Psychiatry)
Massachusetts General Hospital
Eligibility Criteria
Inclusion Criteria
- •Be 12-17 years of age
- •Have a diagnosis of CF
- •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.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Feasibility of the intervention will be indicated by Rate of completion of the CF-CBT-A program sessions once enrolled
Time Frame: From baseline to post-intervention (2-3 months)
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.
Treatment acceptability as measured by item and total score summation on the Client Satisfaction Questionnaire (CSQ-8) with additional study-specific items
Time Frame: immediately post-intervention
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.
Secondary Outcomes
- Change in Health-Related Quality of Life, measured by the Cystic Fibrosis Questionnaire-Revised (CFQ-R)(From baseline to post-intervention (2-3 months))
- Change in Perceived Stress, measured by the PROMIS Pediatric and Parent Proxy Psychological Stress Experiences 8-item short forms(From baseline to post-intervention (2-3 months))
- Change from baseline in Depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9) - adolescent version(From baseline to post-intervention (2-3 months))
- Change from baseline in Anxiety symptoms measured by the Generalized Anxiety Disorder-7 item scale (GAD-7)(From baseline to post-intervention (2-3 months))
- Change in Coping Self-Efficacy, measured by the CF Coping Self-Efficacy Scale - adolescent version(From baseline to post-intervention (2-3 months))