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

Primary Purpose

Generalized Anxiety Disorder

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Acceptance-based Behavior Therapy
Non-directive Supportive Therapy
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Anxiety Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Department and Institute of Psychiatry - FMUSP

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Acceptance-Based Behavior Therapy

Non-directive Supportive Therapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

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+).
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.
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.
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.

Secondary Outcome Measures

Change in the Depression sub scale of 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. We applied the depression factor as a secondary outcome measure. Higher scores indicate higher severity of symptoms. Scores are between 0 and 42. The cut-off scores for conventional severity labels (normal, mild, moderate, severe, extremely severe) for the depression sub scale is (0-9, 10-13, 14-20, 21-27, 28+)
Change in the abridged version of the quality of life inventory - World Health Organization Quality of Life ( WOQOL-BREF - Berlim, Pavanello, Caldieraro, & Fleck, 2005)
The WHOQOL-BREF is a 26-item questionnaire which includes one item from each of the 24 facets contained in the WHOQOL-100 and two additional items on overall quality of life and general health. The 24 items are organized into 4 domains, namely Physical Health, Psychological, Social Relationships and Environment. In this study we analysed only the fis=rst three domains, because environment characteristics was not supposed to change with psychological interventions. The internal consistencies for WHOQOL were .77, .77, and .81 for the psychological subscale, .78, .76, and .82, for the physical subscale, and .72, .64, and .73 for the social subscale across pretreatment, posttreatment, and 3 month follow up. Higher scores indicate higher quality of Life. Scores of physical, psychological and social domains range from 7 to 35; 6 to 30 and 3 to 15.
Change in the Sheehan Disability Scale (Sheehan, Harnett-Sheehan, & Raj, 1996)
It is a discretized analog disability scale (DISS) which uses visual-spatial, numeric and verbal descriptive anchors to assess disability across three domains: work, social life and family life. The internal consistencies for the Sheehan were .71, .80, and .91 across pretreatment, posttreatment, and 3 month follow up. Higher scores indicate higher disability. Scores range from 1 to 10 for each domain.
Change in the Acceptance and Action Questionnaire score
The Acceptance and Action Questionnaire (AAQ-II-7: Bond, 2011; Flederus, 2012) is a 7-item uni-dimensional measure that assesses experiential avoidance: the unwillingness to remain in contact with aversive private experience and behaviors aimed at altering these experiences or the events that elicit them. Items are scored on a 7-point likert scale ranging from 1 (never true) to 7 (always true). Higher scores indicate higher levels of experiential avoidance and lower levels of psychological flexibility
Change in the Five Facets of Mindfulness Questionnaire score
The 39-items Five Facets of Mindfulness Questionnaire (FFMQ; Baer et. al., 2006, adapted for Brazil by Barros, 2014), was used for measuring mindfulness in a multidimensional manner for a factorial analysis of different elements of the construct, divided in five domains (i.e. observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience). Items are scored on a 5-point likert scale ranging from 1 (never or very rarely true) to 5 (very often or always true). Higher scores indicate higher levels of mindfulness.
Change in the Credibility and Expectancy Questionnaire score
The Credibility and Expectancy Questionnaire (CEQ; Borkovec & Nau, 1972; Devilly & Borkovec, 2000) is a 6-item self-report instrument that measures treatment credibility and client expectancy for improvement. The first four items of this scale (set I) are rated based on cognitive appraisal whereas the last two items (set II) are rated based on feelings about the therapy. One item of each set is scored as porcentage (0 to 100) and all of the other items are scored on a 9-point likert scale ranging from 1 (nota t all) to 9 (very). Higher scores indicate higher levels of credibility (first 3 items) and expectancy (last 3 items).
Change in the Mental Health Continuum - Short Form - score
The MHC-SH (Keyes, 2009 - adapted to Brazilian population by Machado and Bandeira, 2015 ) is a 14-item self-responding instrument that measures positive mental health, witch is understood as symptoms of good affection, self development and social connectivity. Items are scored on a 6-point likert scale ranging from 1 (never) to 6 (every day). The score ranges from 14 to 84. Higher scores indicate higher levels of mental health.
Change in serum C-Reactive Protein (CRP)
Blood samples were collected before and after psychological interventions. High sensitivity CRP, expressed in mg/L, was measured using immunoturbidimetric method. High scores indicate cardiovascular risk and/or presence of infectious or inflammatory processes.
Change in serum inflammatory markers
Blood samples were collected before and after psychological interventions. Serum levels of IL-1beta, IL-4, IL-6, IL-8, IL-10, TNFalpha and Vascular Endothelial Growth Factor (VEGF), all expressed in pg/mL, were quantified simultaneously using Luminex xMAP technology with a commercial multiplex immunoassay kit according to the manufacturer's instruction.
Change in Brain Derived Neurotrophic Factor (BDNF) plasma levels
Blood samples were collected before and after psychological intervention. Plasma levels of BDNF were measured using an enzyme-linked immunosorbent assay (ELISA).
Change in serotonin plasma levels
Blood samples were collected before and after psychological intervention. Plasma levels of serotonin were measured using an enzyme-linked immunosorbent assay (ELISA).
Change in the Temperament and Character Inventory - Revised (TCI-R) scores
The TCI-R is a self-reported questionnaire, with 240 questions that require answers in a 5-point-Likert scale. Each question is related to one of the seven factors described by the authors of the scale: novelty seeking, harm avoidance, reward dependence, persistence, self-directedness, cooperativeness and self-transcendence.

Full Information

First Posted
April 15, 2019
Last Updated
June 4, 2020
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03930095
Brief Title
Efficacy of an Acceptance-based Group Behavioral Therapy for Generalized Anxiety Disorder.
Acronym
ABBT-GAD
Official Title
A Randomized Clinical Trial of an Acceptance-based Behavioral Therapy With Mindfulness and Exposure Interventions for Generalized Anxiety Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
February 6, 2016 (Actual)
Primary Completion Date
August 6, 2016 (Actual)
Study Completion Date
August 6, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This was a controlled randomized clinical trial involving 10 sessions of ABBT or 10 sessions of NDST (both in groups) completed within 14 weeks.
Masking
Participant
Masking Description
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.
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acceptance-Based Behavior Therapy
Arm Type
Experimental
Arm Description
10 sessions of a two-hour group therapy with 12 participants during 14 weeks
Arm Title
Non-directive Supportive Therapy
Arm Type
Active Comparator
Arm Description
10 sessions of a two-hour group therapy with 12 participants during 14 weeks
Intervention Type
Behavioral
Intervention Name(s)
Acceptance-based Behavior Therapy
Other Intervention Name(s)
ABBT, Mindfulness-based Behavior Therapy
Intervention Description
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
Intervention Name(s)
Non-directive Supportive Therapy
Other Intervention Name(s)
NDST, Supportive Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the Depression, Anxiety and Stress Scales
Description
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+).
Time Frame
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)
Title
Change in the Hamilton Anxiety Scale
Description
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.
Time Frame
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)
Title
Change in the Penn State Worry Questionnaire (Meyer, 1990)
Description
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.
Time Frame
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)
Title
Change in the Clinical Global Impressions (CGI; Guy, 1976)
Description
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.
Time Frame
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 Outcome Measure Information:
Title
Change in the Depression sub scale of Depression, Anxiety and Stress Scales
Description
The 21-item version (DASS-21; Lovibond e Lovibond, 1995), which measures the scores of depression, anxiety and stress separately. We applied the depression factor as a secondary outcome measure. Higher scores indicate higher severity of symptoms. Scores are between 0 and 42. The cut-off scores for conventional severity labels (normal, mild, moderate, severe, extremely severe) for the depression sub scale is (0-9, 10-13, 14-20, 21-27, 28+)
Time Frame
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)
Title
Change in the abridged version of the quality of life inventory - World Health Organization Quality of Life ( WOQOL-BREF - Berlim, Pavanello, Caldieraro, & Fleck, 2005)
Description
The WHOQOL-BREF is a 26-item questionnaire which includes one item from each of the 24 facets contained in the WHOQOL-100 and two additional items on overall quality of life and general health. The 24 items are organized into 4 domains, namely Physical Health, Psychological, Social Relationships and Environment. In this study we analysed only the fis=rst three domains, because environment characteristics was not supposed to change with psychological interventions. The internal consistencies for WHOQOL were .77, .77, and .81 for the psychological subscale, .78, .76, and .82, for the physical subscale, and .72, .64, and .73 for the social subscale across pretreatment, posttreatment, and 3 month follow up. Higher scores indicate higher quality of Life. Scores of physical, psychological and social domains range from 7 to 35; 6 to 30 and 3 to 15.
Time Frame
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)
Title
Change in the Sheehan Disability Scale (Sheehan, Harnett-Sheehan, & Raj, 1996)
Description
It is a discretized analog disability scale (DISS) which uses visual-spatial, numeric and verbal descriptive anchors to assess disability across three domains: work, social life and family life. The internal consistencies for the Sheehan were .71, .80, and .91 across pretreatment, posttreatment, and 3 month follow up. Higher scores indicate higher disability. Scores range from 1 to 10 for each domain.
Time Frame
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)
Title
Change in the Acceptance and Action Questionnaire score
Description
The Acceptance and Action Questionnaire (AAQ-II-7: Bond, 2011; Flederus, 2012) is a 7-item uni-dimensional measure that assesses experiential avoidance: the unwillingness to remain in contact with aversive private experience and behaviors aimed at altering these experiences or the events that elicit them. Items are scored on a 7-point likert scale ranging from 1 (never true) to 7 (always true). Higher scores indicate higher levels of experiential avoidance and lower levels of psychological flexibility
Time Frame
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)
Title
Change in the Five Facets of Mindfulness Questionnaire score
Description
The 39-items Five Facets of Mindfulness Questionnaire (FFMQ; Baer et. al., 2006, adapted for Brazil by Barros, 2014), was used for measuring mindfulness in a multidimensional manner for a factorial analysis of different elements of the construct, divided in five domains (i.e. observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience). Items are scored on a 5-point likert scale ranging from 1 (never or very rarely true) to 5 (very often or always true). Higher scores indicate higher levels of mindfulness.
Time Frame
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)
Title
Change in the Credibility and Expectancy Questionnaire score
Description
The Credibility and Expectancy Questionnaire (CEQ; Borkovec & Nau, 1972; Devilly & Borkovec, 2000) is a 6-item self-report instrument that measures treatment credibility and client expectancy for improvement. The first four items of this scale (set I) are rated based on cognitive appraisal whereas the last two items (set II) are rated based on feelings about the therapy. One item of each set is scored as porcentage (0 to 100) and all of the other items are scored on a 9-point likert scale ranging from 1 (nota t all) to 9 (very). Higher scores indicate higher levels of credibility (first 3 items) and expectancy (last 3 items).
Time Frame
This scale was administered at the end of each therapy session throughout the entire treatment.
Title
Change in the Mental Health Continuum - Short Form - score
Description
The MHC-SH (Keyes, 2009 - adapted to Brazilian population by Machado and Bandeira, 2015 ) is a 14-item self-responding instrument that measures positive mental health, witch is understood as symptoms of good affection, self development and social connectivity. Items are scored on a 6-point likert scale ranging from 1 (never) to 6 (every day). The score ranges from 14 to 84. Higher scores indicate higher levels of mental health.
Time Frame
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
Title
Change in serum C-Reactive Protein (CRP)
Description
Blood samples were collected before and after psychological interventions. High sensitivity CRP, expressed in mg/L, was measured using immunoturbidimetric method. High scores indicate cardiovascular risk and/or presence of infectious or inflammatory processes.
Time Frame
Before the first session (week 1) and after the last session (week 14)
Title
Change in serum inflammatory markers
Description
Blood samples were collected before and after psychological interventions. Serum levels of IL-1beta, IL-4, IL-6, IL-8, IL-10, TNFalpha and Vascular Endothelial Growth Factor (VEGF), all expressed in pg/mL, were quantified simultaneously using Luminex xMAP technology with a commercial multiplex immunoassay kit according to the manufacturer's instruction.
Time Frame
Before the first session (week 1) and after the last session (week 14)
Title
Change in Brain Derived Neurotrophic Factor (BDNF) plasma levels
Description
Blood samples were collected before and after psychological intervention. Plasma levels of BDNF were measured using an enzyme-linked immunosorbent assay (ELISA).
Time Frame
Before the first session (week 1) and after the last session (week 14)
Title
Change in serotonin plasma levels
Description
Blood samples were collected before and after psychological intervention. Plasma levels of serotonin were measured using an enzyme-linked immunosorbent assay (ELISA).
Time Frame
Before the first session (week 1) and after the last session (week 14)
Title
Change in the Temperament and Character Inventory - Revised (TCI-R) scores
Description
The TCI-R is a self-reported questionnaire, with 240 questions that require answers in a 5-point-Likert scale. Each question is related to one of the seven factors described by the authors of the scale: novelty seeking, harm avoidance, reward dependence, persistence, self-directedness, cooperativeness and self-transcendence.
Time Frame
Pre-treatment (week 0) and after the last session (week 14)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco Lotufo Neto, PhD
Organizational Affiliation
University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department and Institute of Psychiatry - FMUSP
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
05403-903
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

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

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