Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2026-01-05 @ 5:20 PM
Study NCT ID:
NCT03930095
Status:
COMPLETED
Last Update Posted:
2020-06-09
First Post:
2019-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of an Acceptance-based Group Behavioral Therapy for Generalized Anxiety Disorder.
Sponsor:
University of Sao Paulo General Hospital
Organization:
Study Overview
Official Title:
A Randomized Clinical Trial of an Acceptance-based Behavioral Therapy With Mindfulness and Exposure Interventions for Generalized Anxiety Disorder
Status:
COMPLETED
Status Verified Date:
2019-04
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:
ABBT-GAD
Brief Summary:
Generalized anxiety disorder (GAD) shows the weakest treatment response among anxiety disorders. The present study aimed at examining whether an acceptance-based behavioral treatment, combining mindfulness and exposure strategies, would improve clinical outcome compared to a standard, non-directive, supportive group therapy (NDST) for clients at a Brazilian anxiety disorders program.
Detailed Description:
Ninety-two individuals diagnosed with GAD were randomized to receive 10 sessions of either an acceptance-based behavior therapy (ABBT) or a Non-directive support Therapy (NDST). Assessments were at pretreatment, mid term, post-treatment, and 3-month follow-up.Data were analyzed using the Mixed effect regression models comparing both groups in primary outcome measures. Secondary outcome measures and putative process variables were assessed and also analyzed. The latter were tested as mediators of efficacy.
Study Oversight
Has Oversight DMC:
False
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?: