Pilot Study of a CF-specific CBT Intervention for Adolescents

NCT05271643 | Completed DMC

• 1 other identifier: 2021P001492
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  From baseline to post-intervention (2-3 months)

Secondary Outcomes (5)

• 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 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 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 Coping Self-Efficacy, measured by the CF Coping Self-Efficacy Scale - adolescent version

  From baseline to post-intervention (2-3 months)

Study Arms (1)

CF-CBT-A intervention

EXPERIMENTAL

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.

Behavioral: Cognitive Behavioral Therapy (CBT)

Interventions

Cognitive Behavioral Therapy (CBT) 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.

CF-CBT-A intervention

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• \. 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.
• \) Participation in concomitant formal cognitive-behavioral therapy at baseline

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• University at Buffalo: collaborator
• University of Kansas Medical Center: collaborator
• Behavioral Health Systems Research: collaborator

Study Sites (3)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University at Buffalo

New York, New York, 14260, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis; Depression; Anxiety Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Deborah M Friedman, PhD

  Massachusetts General Hospital (MGH)

  PRINCIPAL INVESTIGATOR

• Anna M Georgiopoulos, MD

  Massachusetts General Hospital (MGH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychology (Psychiatry)

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: March 9, 2022
• Study Start: March 2, 2022
• Primary Completion: April 17, 2024
• Study Completion: April 17, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)