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NCT03992027 · ClinicalTrials.gov registry record · NA
Preventing Depression and Anxiety: A Cystic Fibrosis-Specific Cognitive Behavioral Therapy Intervention
A NA study of Depression and Anxiety, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 4
- Study locations
NCT03992027 is a NA study of Depression and Anxiety that has completed, run by Massachusetts General Hospital. The registered enrollment target is 60 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (92% lower). The trial reports 4 study locations across 4 states.
The verdict
NCT03992027, a NA study of Depression and Anxiety, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 4
- Study locations
Study Summary
Individuals with Cystic Fibrosis (CF) are at high risk for depression and anxiety, with negative consequences for quality of life, ability to carry out daily CF treatments, and health. CF Foundation and European CF Society guidelines recommend routine screening, treatment, and preventative efforts for depression and anxiety. Cognitive-behavioral therapy (CBT) interventions focused on teaching coping skills have a large evidence-base for prevention and treatment of depression and anxiety, but there are barriers to accessing these interventions for individuals with CF. Drs. Friedman and Georgiopoulos at Massachusetts General Hospital (MGH) have developed a CF-specific CBT-based preventive intervention for depression and anxiety with input from adults with CF and CF healthcare team members, called CF-CBT: A cognitive-behavioral skills-based program to promote emotional well-being for adults with CF, along with a training and supervision program for CF team interventionists. CF-CBT consists of 8 45-minute modules that can be flexibly delivered in the outpatient CF clinic, on the inpatient unit, or by telephone, by multidisciplinary members of the CF care team, minimizing additional cost and burden of care to patients. The goal of this study is to test CF-CBT in 60 adults screening in the mild range on measures of depression and anxiety at 4 CF centers, in a prospective randomized clinical trial comparing the intervention to usual treatment. Participants will be randomized to receive the CF-CBT intervention immediately, or to a 3-month waitlist control followed by intervention. The study will measure depression, anxiety, quality of life, stress, and coping self-efficacy before and after the CF-CBT intervention, and also 3 and 6 months post-intervention.
Conditions Studied
Interventions
- BEHAVIORAL Waitlist Control
- BEHAVIORAL CF-CBT: A Cognitive-Behavioral Skills-Based Program to Promote Emotional Well-Being for Adults wtih Cystic Fibrosis
Study Locations (4)
California
- Stanford University - Palo Alto
Kansas
- University of Kansas Medical Center - Kansas City
Massachusetts
- Massachusetts General Hospital - Boston
New York
- University at Buffalo - Buffalo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2019-07-22 |
| Est. Completion | 2022-10-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03992027
The ClinicalTrials.gov registry entry for NCT03992027 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 786-participant average among 679 other Depression trials with a reported enrollment target (92% lower). The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Depression appearing as the primary indexed condition, and to 2 interventions - of which Waitlist Control is the first listed.
NCT03992027 reports 4 study locations spanning 4 distinct geographic areas - top geographies include California, Kansas, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03992027 about?
NCT03992027 is a clinical study titled "Preventing Depression and Anxiety: A Cystic Fibrosis-Specific Cognitive Behavioral Therapy Intervention". Individuals with Cystic Fibrosis (CF) are at high risk for depression and anxiety, with negative consequences for quality of life, ability to carry out daily CF treatments, and health. CF Foundation and European CF Society guidelines recommend routine screening, treatment, and preventative efforts f...
What is the current status of trial NCT03992027?
This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2019-07-22. Estimated completion is 2022-10-31.
What conditions does trial NCT03992027 study?
This clinical trial studies the following conditions: Depression, Anxiety.
What interventions are being tested in trial NCT03992027?
The interventions under investigation include: Waitlist Control (BEHAVIORAL), CF-CBT: A Cognitive-Behavioral Skills-Based Program to Promote Emotional Well-Being for Adults wtih Cystic Fibrosis (BEHAVIORAL).
Who is sponsoring clinical trial NCT03992027?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03992027 being conducted?
This trial has 4 study locations across California, Kansas, Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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