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NCT05271643 · ClinicalTrials.gov registry record · NA

Pilot Study of a CF-specific CBT Intervention for Adolescents

A NA study, sponsored by Massachusetts General Hospital.

Completed
Registry status
NA
Development phase
12
Enrollment target

NCT05271643: Completed NA study, sponsored by Massachusetts General Hospital.

NCT05271643 is a NA study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 12 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05271643, a NA study, has completed, sponsored by Massachusetts General Hospital.

COMPLETED
Registry status
NA
Development phase
12 participants
Enrollment target

Study 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.

Primary Outcome

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.

Interventions

  • BEHAVIORAL Cognitive Behavioral Therapy (CBT)

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2022-03-02
Est. Completion 2024-04-17
Phase NA
Massachusetts General Hospital

2,032 total trials

What the finished NCT05271643 record still lists

NCT05271643 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 1 intervention - of which Cognitive Behavioral Therapy (CBT) is the first listed.

NCT05271643 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05271643 about?

NCT05271643 is a clinical study titled "Pilot Study of a CF-specific CBT Intervention for Adolescents". 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 te...

What is the current status of trial NCT05271643?

This trial is currently completed. It is a NA study. The enrollment target is 12 participants. The study started on 2022-03-02. Estimated completion is 2024-04-17.

What interventions are being tested in trial NCT05271643?

The interventions under investigation include: Cognitive Behavioral Therapy (CBT) (BEHAVIORAL).

Who is sponsoring clinical trial NCT05271643?

This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05271643's enrollment target sits among peer trials

12 1913th of 2000 higher than 74 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05271643, the US trial registry maintained by the National Library of Medicine. NCT05271643 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.