NCT05271643

Pilot Study of a CF-specific CBT Intervention for Adolescents

Preventing Depression and Anxiety: a Pilot Study of a Cystic-fibrosis Specific Cognitive-behavioral Therapy Intervention for Adolescents With CF

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cystic Fibrosis
• Depression
• Anxiety

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive Behavioral Therapy (CBT)	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.

Timeline

• Start date: 2022-03-02
• Primary completion: 2024-04-17
• Completion: 2024-04-17
• First posted: 2022-03-09
• Last updated: 2024-09-19

Locations

3 sites across 1 country: United States