Efficacy of an Acceptance-based Group Behavioral Therapy for Generalized Anxiety Disorder. (ABBT-GAD)

University of Sao Paulo General Hospital

Status: Completed

Conditions: Generalized Anxiety Disorder

Treatments: Behavioral: Non-directive Supportive Therapy; Behavioral: Acceptance-based Behavior Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03930095

51363615.4.0000.0068

Details and patient eligibility

About

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.

Full 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.

Enrollment: 92 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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92 participants in 2 patient groups

Acceptance-Based Behavior Therapy

Experimental group

Description:

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

Treatment:

Behavioral: Acceptance-based Behavior Therapy

Non-directive Supportive Therapy

Active Comparator group

Description:

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

Treatment:

Behavioral: Non-directive Supportive Therapy