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

NCT ID: NCT03930095

Last Updated: 2020-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-06
• Study Completion Date: 2016-08-06

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.

Conditions

Generalized Anxiety Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Acceptance-Based Behavior Therapy

10 sessions of a two-hour group therapy with 12 participants during 14 weeks

Group Type: EXPERIMENTAL

Acceptance-based Behavior Therapy

Intervention Type: BEHAVIORAL

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.

Non-directive Supportive Therapy

10 sessions of a two-hour group therapy with 12 participants during 14 weeks

Group Type: ACTIVE_COMPARATOR

Non-directive Supportive Therapy

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

ABBT; Mindfulness-based Behavior Therapy; NDST; Supportive Therapy

Eligibility Criteria

Inclusion Criteria

• Literate,
• GAD-diagnosed
• 18-65 years old

Exclusion Criteria

• Bipolar disorder (or any past maniac episodes),
• Psychosis,
• Substance dependence (apart from those abstemious for 3 months or more, considered as initial remission by DSM 5 - APA, 2015),
• High suicide risks according to the MINI - International Neuropsychiatric Interview (MINI; Sheehan et al., 1998).
• Participants under pharmacological treatment for GAD whose medication dosage had not been stable for a minimum of three months prior to the beginning of the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francisco Lotufo Neto, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

Department and Institute of Psychiatry - FMUSP

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

51363615.4.0000.0068

Identifier Type: -

Identifier Source: org_study_id