Pilot Study of a CF-specific CBT Intervention for Adolescents

Study Overview
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Brief Summary
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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.

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

Conditions
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Anxiety, Cystic Fibrosis, Depression

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy (CBT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CF-CBT-A intervention<br>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)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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) | 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. | 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 | 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). | From baseline to post-intervention (2-3 months) | 
| 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. | From baseline to post-intervention (2-3 months) | 
| 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'. | From baseline to post-intervention (2-3 months) |