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Pilot Study of a CF-specific CBT Intervention for Adolescents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT05271643
Recruitment Status : Recruiting
First Posted : March 9, 2022
Last Update Posted : April 6, 2022
University at Buffalo
University of Kansas Medical Center
Behavioral Health Systems Research
Information provided by (Responsible Party):
Deborah Friedman, Massachusetts General Hospital

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 moderate symptoms of depression or 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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Depression Anxiety Behavioral: Cognitive Behavioral Therapy (CBT) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preventing Depression and Anxiety: a Pilot Study of a Cystic-fibrosis Specific Cognitive-behavioral Therapy Intervention for Adolescents With CF
Actual Study Start Date : March 2, 2022
Estimated Primary Completion Date : October 31, 2022
Estimated Study Completion Date : October 31, 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 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.
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.

Primary Outcome Measures :
  1. 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.

  2. 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.

Secondary Outcome Measures :
  1. Change from baseline in Depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9) - adolescent version [ Time Frame: From baseline to post-intervention (2-3 months) ]
    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.

  2. Change from baseline in Anxiety symptoms measured by the Generalized Anxiety Disorder-7 item scale (GAD-7) [ Time Frame: From baseline to post-intervention (2-3 months) ]
    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.

  3. Change in Perceived Stress, measured by the PROMIS Pediatric and Parent Proxy Psychological Stress Experiences 8-item short forms [ Time Frame: From baseline to post-intervention (2-3 months) ]
    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).

  4. Change in Health-Related Quality of Life, measured by the Cystic Fibrosis Questionnaire-Revised (CFQ-R) [ Time Frame: From baseline to post-intervention (2-3 months) ]
    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.

  5. Change in Coping Self-Efficacy, measured by the CF Coping Self-Efficacy Scale - adolescent version [ Time Frame: From baseline to post-intervention (2-3 months) ]
    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'.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT05271643

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Contact: Deborah Friedman, PhD 617-724-8598
Contact: Anna M Georgiopoulos, MD 6176432330 AGEORGIOPOULOS@PARTNERS.ORG

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United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Amanda Bruce, PhD   
Principal Investigator: Amanda Bruce, PhD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Deborah M Friedman, PhD    617-724-8598   
Principal Investigator: Deborah Friedman, PhD         
Principal Investigator: Anna M Georgiopoulos, MD         
United States, New York
University at Buffalo Not yet recruiting
New York, New York, United States, 14260
Contact: Beth Smith, MD   
Principal Investigator: Beth Smith, MD         
Sponsors and Collaborators
Massachusetts General Hospital
University at Buffalo
University of Kansas Medical Center
Behavioral Health Systems Research
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Principal Investigator: Deborah M Friedman, PhD Massachusetts General Hospital (MGH)
Principal Investigator: Anna M Georgiopoulos, MD Massachusetts General Hospital (MGH)
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Responsible Party: Deborah Friedman, Assistant Professor of Psychology (Psychiatry), Massachusetts General Hospital Identifier: NCT05271643    
Other Study ID Numbers: 2021P001492
First Posted: March 9, 2022    Key Record Dates
Last Update Posted: April 6, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cystic Fibrosis
Behavioral Symptoms
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases