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
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Acceptance-based Behavior Therapy | The 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. |
| BEHAVIORAL | Non-directive Supportive Therapy | NDST 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.