A Randomized Clinical Trial of an Acceptance-based Behavioral Therapy With Mindfulness and Exposure Interventions for Generalized Anxiety Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Change in the Hamilton Anxiety Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Literate,
- •GAD-diagnosed
- •18-65 years old
排除标准
- •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.
研究组 & 干预措施
Acceptance-Based Behavior Therapy
10 sessions of a two-hour group therapy with 12 participants during 14 weeks
干预措施: Acceptance-based Behavior Therapy (Behavioral)
Non-directive Supportive Therapy
10 sessions of a two-hour group therapy with 12 participants during 14 weeks
干预措施: Non-directive Supportive Therapy (Behavioral)
结局指标
主要结局
Change in the Hamilton Anxiety Scale
时间窗: 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 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 Clinical Global Impressions (CGI; Guy, 1976)
时间窗: 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 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.
Change in the Depression, Anxiety and Stress Scales
时间窗: 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 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 Penn State Worry Questionnaire (Meyer, 1990)
时间窗: 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)
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.
次要结局
- Change in serotonin plasma levels(Before the first session (week 1) and after the last session (week 14))
- 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 serum inflammatory markers(Before the first session (week 1) and after the last session (week 14))
- Change in Brain Derived Neurotrophic Factor (BDNF) plasma levels(Before the first session (week 1) and after the last session (week 14))
- 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 Credibility and Expectancy Questionnaire score(This scale was administered at the end of each therapy session throughout the entire treatment.)
- 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))
- Change in serum C-Reactive Protein (CRP)(Before the first session (week 1) and after the last session (week 14))
- 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 Mental Health Continuum - Short Form - score(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 Temperament and Character Inventory - Revised (TCI-R) scores(Pre-treatment (week 0) and after the last session (week 14))