Clinical Trials Directory

Trials / Completed

CompletedNCT03930095

Efficacy of an Acceptance-based Group Behavioral Therapy for Generalized Anxiety Disorder.

A Randomized Clinical Trial of an Acceptance-based Behavioral Therapy With Mindfulness and Exposure Interventions for Generalized Anxiety Disorder

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
92 (actual)
Sponsor
University of Sao Paulo General Hospital · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALAcceptance-based Behavior TherapyThe protocol is widely based on Roemer and Orsillo (2007) acceptance model of GAD, using functional assessment, psychoeducation, mindfulness, commitment to valued behavior, and exposure techniques used in a willingness improvement verbal context.
BEHAVIORALNon-directive Supportive TherapyNDST consists in a form of therapeutic intervention from which all intervention principles pertaining to specific psychotherapeutic protocols are removed while maintaining the so-called common factors from different psychotherapy approaches. In other words, it is an unstructured therapy without specific psychological techniques other than those belonging to the basic interpersonal skills of the therapist, such as reflection, empathic listening, encouragement, and helping people to explore and express their experiences and emotions.

Timeline

Start date
2016-02-06
Primary completion
2016-08-06
Completion
2016-08-06
First posted
2019-04-29
Last updated
2020-06-09

Locations

1 site across 1 country: Brazil

Source: ClinicalTrials.gov record NCT03930095. Inclusion in this directory is not an endorsement.