Clinical trial NCT03930095: Efficacy of an Acceptance-based Group Behavioral Therapy for Generalized Anxiety Disorder.
Official title: A Randomized Clinical Trial of an Acceptance-based Behavioral Therapy With Mindfulness and Exposure Interventions for Generalized Anxiety Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Generalized Anxiety Disorder
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2019-04-29
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in the Depression, Anxiety and Stress Scales
timeFrame: 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)
measure: Change in the Hamilton Anxiety Scale
timeFrame: 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)
measure: Change in the Penn State Worry Questionnaire (Meyer, 1990)
timeFrame: 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)
measure: Change in the Clinical Global Impressions (CGI; Guy, 1976)
timeFrame: 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:
measure: Change in the Depression sub scale of Depression, Anxiety and Stress Scales
timeFrame: 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)
measure: Change in the abridged version of the quality of life inventory - World Health Organization Quality of Life ( WOQOL-BREF - Berlim, Pavanello, Caldieraro, & Fleck, 2005)
timeFrame: 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)
measure: Change in the Sheehan Disability Scale (Sheehan, Harnett-Sheehan, & Raj, 1996)
timeFrame: 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)
measure: Change in the Acceptance and Action Questionnaire score
timeFrame: 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)
measure: Change in the Five Facets of Mindfulness Questionnaire score
timeFrame: 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)
measure: Change in the Credibility and Expectancy Questionnaire score
timeFrame: This scale was administered at the end of each therapy session throughout the entire treatment.
measure: Change in the Mental Health Continuum - Short Form - score
timeFrame: 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
measure: Change in serum C-Reactive Protein (CRP)
timeFrame: Before the first session (week 1) and after the last session (week 14)
measure: Change in serum inflammatory markers
timeFrame: Before the first session (week 1) and after the last session (week 14)
measure: Change in Brain Derived Neurotrophic Factor (BDNF) plasma levels
timeFrame: Before the first session (week 1) and after the last session (week 14)
measure: Change in serotonin plasma levels
timeFrame: Before the first session (week 1) and after the last session (week 14)
measure: Change in the Temperament and Character Inventory - Revised (TCI-R) scores
timeFrame: Pre-treatment (week 0) and after the last session (week 14)
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Department and Institute of Psychiatry - FMUSP
state: Sao Paulo
Study officials:
affiliation: University of Sao Paulo
name: Francisco Lotufo Neto, PhD
role: PRINCIPAL_INVESTIGATOR
References: