Pilot Study of a CF-specific CBT Intervention for Adolescents

NCT ID: NCT05271643

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-02
• Study Completion Date: 2024-04-17

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.

Conditions

Cystic Fibrosis; Depression; Anxiety

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CF-CBT-A intervention

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.

Group Type: EXPERIMENTAL

Cognitive Behavioral Therapy (CBT)

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Be 12-17 years of age

2. Have a diagnosis of CF

3. 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).

4. Be able to speak and read English

5. Be willing and able to provide assent

6. Have a parent who is willing and able to provide informed consent for their own and adolescent participation

7. 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.

8. Subjects will not be excluded for the following reasons:

1. 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.

2. A history of more severe depression currently at mild to moderate levels with or without treatment.

3. 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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University at Buffalo

OTHER

Sponsor Role: collaborator

University of Kansas Medical Center

OTHER

Sponsor Role: collaborator

Behavioral Health Systems Research

UNKNOWN

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Deborah Friedman

Assistant Professor of Psychology (Psychiatry)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deborah M Friedman, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital (MGH)

Anna M Georgiopoulos, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital (MGH)

Locations

University of Kansas Medical Center

Kansas City, Kansas, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

University at Buffalo

New York, New York, United States

Countries

United States

Other Identifiers

2021P001492

Identifier Type: -

Identifier Source: org_study_id