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Generalized Anxiety DisorderABBT-GADNCT03930095

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

A study testing Acceptance-based Behavior Therapy and Non-directive Supportive Therapy in people with Generalized Anxiety Disorder, run by University of Sao Paulo General Hospital at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Generalized Anxiety Disorder
What is being tested?
Acceptance-based Behavior Therapy and Non-directive Supportive Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
92 participants
Where
1 siteBrazil
Study dates
6 Feb 2016to 6 Aug 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Brazil1 site

  • Department and Institute of Psychiatry - FMUSP

    São Paulo, São Paulo, 05403-903

Other trials in Brazil

About this study

Official title: A Randomized Clinical Trial of an Acceptance-based Behavioral Therapy With Mindfulness and Exposure Interventions for Generalized Anxiety Disorder

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.

Read the 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.

Being tested
Acceptance-based Behavior Therapy, Non-directive Supportive Therapy
Medical subject headings
Generalized Anxiety Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Acceptance-based Behavior TherapyBehavioural

    Also called ABBT, Mindfulness-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.

  • Non-directive Supportive TherapyBehavioural

    Also called NDST, 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.

Study groups in NCT03930095
Study groupRoleWhat they receive
Acceptance-Based Behavior TherapyExperimental10 sessions of a two-hour group therapy with 12 participants during 14 weeks
Receives: Behavioral: Acceptance-based Behavior Therapy
Non-directive Supportive TherapyActive comparator10 sessions of a two-hour group therapy with 12 participants during 14 weeks
Receives: Behavioral: Non-directive Supportive Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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+).

    Measured: 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)

  2. 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.

    Measured: 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)

  3. 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.

    Measured: 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)

  4. 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.

    Measured: 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)

  1. 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+)

    Measured: 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)

  2. 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.

    Measured: 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)

  3. 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.

    Measured: 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)

  4. 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

    Measured: 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)

  5. 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.

    Measured: 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)

  6. 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).

    Measured: This scale was administered at the end of each therapy session throughout the entire treatment.

  7. 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.

    Measured: 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

  8. 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.

    Measured: Before the first session (week 1) and after the last session (week 14)

  9. 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.

    Measured: Before the first session (week 1) and after the last session (week 14)

  10. 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).

    Measured: Before the first session (week 1) and after the last session (week 14)

  11. 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).

    Measured: Before the first session (week 1) and after the last session (week 14)

  12. 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.

    Measured: Pre-treatment (week 0) and after the last session (week 14)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2019
  2. Study start6 Feb 2016
  3. Primary completion6 Aug 2016
  4. Study completion6 Aug 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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
Single blind
Who is masked
Participant
Enrolment
92 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03930095
Sponsor's protocol ID
51363615.4.0000.0068
Acronym
ABBT-GAD
Status last verified
Apr 2019
First submitted
15 Apr 2019
Last updated
9 Jun 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gandarela L, Sampaio TPA, Marcal L, Burdmann EA, Neto FL, Bernik MA. Increased brain-derived neurotrophic factor following successful psychological treatment in generalized anxiety disorder: a randomized clinical trial. BMC Psychiatry. 2026 Apr 7;26(1):396. doi: 10.1186/s12888-026-08027-8.

    PubMed 41947092

Questions about this trial

What is this clinical trial studying?

A study testing Acceptance-based Behavior Therapy and Non-directive Supportive Therapy in people with Generalized Anxiety Disorder, run by University of Sao Paulo General Hospital at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the Depression, Anxiety and Stress Scales (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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03930095, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2020.

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