NCT05271643Completed
Pilot Study of a CF-specific CBT Intervention for Adolescents
Preventing Depression and Anxiety: a Pilot Study of a Cystic-fibrosis Specific Cognitive-behavioral Therapy Intervention for Adolescents With CF
Source: ClinicalTrials.gov · Last updated 19 Sept 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 12 (actual)
- First submitted
- 28 Feb 2022
- Start date
- 2 Mar 2022
- Primary completion date
- 17 Apr 2024
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- Cystic fibrosis
- NCT number
- NCT05271643
What you commit to
- Study type: Interventional
- Participants enrolled: 12
- From 2 Mar 2022 to the primary completion date, 17 Apr 2024
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 2\) Participation in concomitant formal cognitive-behavioral therapy at baseline
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 12 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| University of Kansas Medical Center Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| University at Buffalo Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.