Clinical trial NCT05271643: Pilot Study of a CF-specific CBT Intervention for Adolescents
Official title: Preventing Depression and Anxiety: a Pilot Study of a Cystic-fibrosis Specific Cognitive-behavioral Therapy Intervention for Adolescents With CF
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Depression
Anxiety
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: University at Buffalo
name: University of Kansas Medical Center
name: Behavioral Health Systems Research
First posted: 2022-03-09
Enrollment: 12
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Treatment acceptability as measured by item and total score summation on the Client Satisfaction Questionnaire (CSQ-8) with additional study-specific items
timeFrame: immediately post-intervention
measure: Feasibility of the intervention will be indicated by Rate of completion of the CF-CBT-A program sessions once enrolled
timeFrame: From baseline to post-intervention (2-3 months)
Secondary outcomes:
measure: Change from baseline in Depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9) - adolescent version
timeFrame: From baseline to post-intervention (2-3 months)
measure: Change from baseline in Anxiety symptoms measured by the Generalized Anxiety Disorder-7 item scale (GAD-7)
timeFrame: From baseline to post-intervention (2-3 months)
measure: Change in Perceived Stress, measured by the PROMIS Pediatric and Parent Proxy Psychological Stress Experiences 8-item short forms
timeFrame: From baseline to post-intervention (2-3 months)
measure: Change in Health-Related Quality of Life, measured by the Cystic Fibrosis Questionnaire-Revised (CFQ-R)
timeFrame: From baseline to post-intervention (2-3 months)
measure: Change in Coping Self-Efficacy, measured by the CF Coping Self-Efficacy Scale - adolescent version
timeFrame: From baseline to post-intervention (2-3 months)
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: New York
country: United States
facility: University at Buffalo
state: New York
Study officials:
affiliation: Massachusetts General Hospital (MGH)
name: Deborah M Friedman, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital (MGH)
name: Anna M Georgiopoulos, MD
role: PRINCIPAL_INVESTIGATOR
References: