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

NCT03930095 | Completed

• 1 other identifier: 51363615.4.0000.0068
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Generalized Anxiety Disorder

Outcome Measures

Primary Outcomes (4)

• Change in the Depression, Anxiety and Stress Scales

  The 21-item version (DASS-21; Lovibond e Lovibond, 1995), which measures the scores of depression, anxiety and stress separately (7-items each). We followed Roemer \& Orsillo (2008) in this study by using the anxiety and stress subscales as general signs of anxiety. Higher scores indicate higher severity of symptoms. Scores are between 0 and 42 for each one of the three subscales. The cut-off scores for conventional severity labels (normal, mild, moderate, severe, extremely severe) are as follows: Anxiety (0-7; 8-9; 10-14; 14-19; 20+) and Stress (0-14; 15-18; 19-25; 26-33; 34+).

  Pre-treatment (week 0) one week before the first group session (week 1); intermediate assessment (midterm) in the sixth session (week 6); the post-treatment assessment occurred on the day of the tenth session (week 14); and follow-up (week 26)

• Change in the Hamilton Anxiety Scale

  The Hamilton Anxiety Scale (Hamilton, 1959, The assessment of anxiety states by rating) was used to measure anxiety symptoms. The HAM-A is a 14-item interview-administered measure of anxiety widely used in clinical trials, being required as an inclusion criterion in meta-analyses of psychological treatments for anxiety disorders (Bandelow, 2015). Higher scores indicate higher levels of anxious symptoms. The internal consistencies for the HAM-A were .84, .81, .80, and .86 across the four time points. The score ranges from 0 to 54.

  Pre-treatment (week 0) one week before the first group session (week 1); intermediate assessment (midterm) in the sixth session (week 6); the post-treatment assessment occurred on the day of the tenth session (week 14); and follow-up (week 26)

• Change in the Penn State Worry Questionnaire (Meyer, 1990)

  it is a 16-item 5-points likert questionnaire with items ranging from 1 (not at all typical of me) to 5 (very typical of me) that measures the trait levels of worry. the scale ranges from 16 to 80. Higher scores indicate higher levels of worry.Its internal consistencies in the current sample were .91, .89, .90, and .92 across the four time points.

  Pre-treatment (week 0) one week before the first group session (week 1); intermediate assessment (midterm) in the sixth session (week 6); the post-treatment assessment occurred on the day of the tenth session (week 14); and follow-up (week 26)

• Change in the Clinical Global Impressions (CGI; Guy, 1976)

  The CGI provides an overall clinician-determined summary measure that takes into account all available information, including a knowledge of the patient's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the patient's ability to function.The CGI actually comprises two companion one-item measures evaluating the following: (a) severity of psychopathology from 1 to 7 and (b) change from the initiation of treatment on a similar seven-point scale (Busner \& Targum, 2007). Higher scores indicate higher severity of symptoms or worse evolution.

  Pre-treatment (week 0) one week before the first group session (week 1); intermediate assessment (midterm) in the sixth session (week 6); the post-treatment assessment occurred on the day of the tenth session (week 14); and follow-up (week 26)

Secondary Outcomes (12)

• Change in the Depression sub scale of Depression, Anxiety and Stress Scales

  Pre-treatment (week 0) one week before the first group session (week 1); intermediate assessment (midterm) in the sixth session (week 6); the post-treatment assessment occurred on the day of the tenth session (week 14); and follow-up (week 26)

• Change in the abridged version of the quality of life inventory - World Health Organization Quality of Life ( WOQOL-BREF - Berlim, Pavanello, Caldieraro, & Fleck, 2005)

  Pre-treatment (week 0) one week before the first group session (week 1); the post-treatment assessment occurred on the day of the tenth session (week 14); and follow-up (week 26)

• Change in the Sheehan Disability Scale (Sheehan, Harnett-Sheehan, & Raj, 1996)

  Pre-treatment (week 0) one week before the first group session (week 1); the post-treatment assessment occurred on the day of the tenth session (week 14); and follow-up (week 26)

• Change in the Acceptance and Action Questionnaire score

  Pre-treatment (week 0) one week before the first group session (week 1); intermediate assessment (midterm) in the sixth session (week 6); the post-treatment assessment occurred on the day of the tenth session (week 14); and follow-up (week 26)

• Change in the Five Facets of Mindfulness Questionnaire score

  Pre-treatment (week 0) one week before the first group session (week 1); intermediate assessment (midterm) in the sixth session (week 6); the post-treatment assessment occurred on the day of the tenth session (week 14); and follow-up (week 26)

Study Arms (2)

Acceptance-Based Behavior Therapy

EXPERIMENTAL

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

Behavioral: Acceptance-based Behavior Therapy

Non-directive Supportive Therapy

ACTIVE COMPARATOR

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

Behavioral: Non-directive Supportive Therapy

Interventions

Acceptance-based Behavior Therapy 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.

Also known as: ABBT, Mindfulness-based Behavior Therapy

Acceptance-Based Behavior Therapy

Non-directive Supportive Therapy 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.

Also known as: NDST, Supportive Therapy

Non-directive Supportive Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Literate,
• GAD-diagnosed
• years old

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Department and Institute of Psychiatry - FMUSP

São Paulo, São Paulo, 05403-903, Brazil

Location

MeSH Terms

Conditions

Generalized Anxiety Disorder

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Francisco Lotufo Neto, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: After all the participants signed a consent form, each subject was randomized to a single treatment by using the method of randomly permuted blocks (Matts \& Lachin, 1988) on http://www.randomization.com. Randomization was stratified in two blocs by use of psychotropic medication in order to have medication use equally distributed between groups. To that end, patients on psychotropic medication were randomized first.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This was a controlled randomized clinical trial involving 10 sessions of ABBT or 10 sessions of NDST (both in groups) completed within 14 weeks.

Study Record Dates

• First Submitted: April 15, 2019
• First Posted: April 29, 2019
• Study Start: February 6, 2016
• Primary Completion: August 6, 2016
• Study Completion: August 6, 2016
• Last Updated: June 9, 2020

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)