Status:
COMPLETED
Pilot Study of a CF-specific CBT Intervention for Adolescents
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
University at Buffalo
University of Kansas Medical Center
Conditions:
Cystic Fibrosis
Depression
Eligibility:
All Genders
12-17 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 17 2024
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT05271643
Start Date
March 2 2022
End Date
April 17 2024
Last Update
September 19 2024
Active Locations (3)
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1
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
3
University at Buffalo
New York, New York, United States, 14260