Ignite Creation Date:
2024-05-06 @ 1:21 PM
Last Modification Date:
2024-10-26 @ 1:12 PM
Study NCT ID:
NCT03992027
Status:
COMPLETED
Last Update Posted:
2023-07-25
First Post:
2019-06-18
Brief Title:
Preventing Depression and Anxiety A Cystic Fibrosis-Specific Cognitive Behavioral Therapy Intervention
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Preventing Depression and Anxiety A Randomized Controlled Trial of a CF-Specific CBT Intervention
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| FRIEDM18A0 | OTHER_GRANT | Cystic Fibrosis Foundation Therapeutics Inc | None |