A Randomized Single-blind Trial in Adult Population With Anxiety Disorders: Comparison of a Mindfulness-based Emotional Regulation Program Versus an Acceptance and Commitment Therapy-based Intervention
试验速览
- 阶段
- 不适用
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Trail Making Test (TMT)
研究概览
简要总结
Background: There is a paucity of randomized clinical trials which address the relationship between training in mindfulness and neuropsychological outcomes. Also, how psychotherapeutic interventions were delivered before and during the COVID-19 pandemic and its possible differential results need more scientific attention.
Aims: To compare the effectiveness of an intervention based on the Acceptance and Commitment Therapy (ACT) versus a Mindfulness-based Emotional Regulation (MER) intervention among adult patients with anxiety disorders.
Methods: This randomized, single-blind, clinical trial is being conducted in a community Mental Health Unit (Colmenar Viejo, Madrid) in Spain. Potential outpatients will be over 18 years (until 75 years) with some type of specific or unspecified anxiety disorder. They will be assessed for inclusion/exclusion criteria and randomized according to the score on the Acceptance and Action Questionnaire-II (used as a blocking factor). One of the interventions was adapted from the Acceptance and Commitment Therapy (ACT) for anxiety disorders and MER was based on the Mindfulness-Based Stress Reduction program. Each intervention has been designed to be weekly, during 8 weeks, guided by two Clinical Psychology residents. Interventions have been delivered face-to-face before the COVID-19 pandemic, or via online currently. A 2x3 mixed-factorial ANOVA (intervention type x pre-treatment, post-treatment and 6-month follow-up) will be conducted, with Sidak-correction post hoc tests. The primary measures are the TMT score (A and B forms), Stroop test, Digit span subtests from the Wechsler Adult Intelligence Scale, version IV (Forward, Backward and Sequencing subtests), Acceptance and Action Questionnaire-II, and Anxiety Sensitivity Index-3 (ASI-3). Secondary measures are the Five Facets Mindfulness Questionnaire (FFMQ), Toronto Alexithymia Scale 20-item (TAS-20), Reflective Functioning Questionnaire (RFQ-8), Hospital Anxiety and Depression Scale (HADS), and the World Health Organization's Quality of Life Questionnaire (WHOQOL-BREF). Norms based on the Spanish general population will be used.
Results: This clinical trial started in February 2019 and it is expected to end in September 2023. The minimum sample size required is 128 participants (64 each intervention) to achieve medium effect sizes on primary outcomes (alfa = .05 and beta = .20). So far, 107 adult patients with anxiety disorders participated (64 participants in face-to-face interventions before the COVID-19 pandemic; and 43 participants via online, during the pandemic).
Conclusions: This is the first study to compare two mindfulness-based interventions on several neurocognitive functions and other psychological domains among adult patients with anxiety disorders.
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
Participants will be randomized according to the score on the Acceptance and Action Questionnaire-II (blocking factor) without knowing the treatment they were allocated to.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Spanish as mother tongue or a very high level in Spanish to understand the patient information sheet, the informed consent, as well as being able to follow the group intervention sessions and the homework.
- •Diagnosis of an anxiety disorder, avoidant personality disorder, adjustment disorders with anxious/anxious-depressive symptomatology, as well as unspecified anxiety disorders.
排除标准
- •Continuing individual psychotherapeutic treatment from the beginning of the group intervention until the end of it.
- •Other diagnoses of severe mental disorder; cluster A or B personality disorders; and/or substance use disorder in the past 6 months.
- •Diagnosis of intellectual disability, mild cognitive impairment or dementia.
- •Changes in psychopharmacological treatment (in active ingredient or doses) in the month before each intervention.
- •Diagnosis of uncontrolled or non-stabilized organic disease.
研究组 & 干预措施
Acceptance and Commitment Therapy (ACT)
Intervention based on Acceptance and Commitment Therapy that promotes the acceptance and defusion of unwanted internal experiences and commitment to values of the personal life project.
干预措施: Acceptance and Commitment Therapy (ACT) (Behavioral)
Mindfulness-based Emotional Regulation (MER)
Intervention inspired in the Mindfulness-Based Stress Reduction program that fosters the development of a behavioral pattern made up of conscious responses in order to decrease reactivity to stressors.
干预措施: Mindfulness-based Emotional Regulation (MER) (Behavioral)
结局指标
主要结局
Trail Making Test (TMT)
时间窗: 8 months
It evaluates selective/alternative visual attention by the time of execution (seconds)
The Acceptance and Action Questionnaire-II (AAQ-II)
时间窗: 8 months
It evaluates experiential avoidance and psychological inflexibility. It is a 7-item self-report instrument, rated on a 7-point Likert scale, with a total scale score ranging from 7 to 49. Higher scores indicate higher levels of experiential avoidance and psychological inflexibility
Stroop Color-Word Interference Test
时间窗: 8 months
It measures processing speed and visual inhibitory control by the total number of items achieved
The Anxiety Sensitivity Index-3 (ASI-3)
时间窗: 8 months
It measures concerns associated with possible negative consequences of anxiety-related symptoms in three dimensions (physical, cognitive and social). It is an 18-item self-report, rated on a 5-point Likert scale, with a total scale score (ranging from 0 to 72) and three 6-item subscales (Physical, Cognitive and Social Concerns, ranging from 0 to 24 points each). Higher scores indicate higher anxiety sensitivity
Digit span subtests from the Wechsler Adult Intelligence Scale, version IV (WAIS-IV): Forward, Backward and Sequencing subtests
时间窗: 8 months
It evaluates span of immediate recall and verbal working memory by the total number of items achieved and the maximum number of remembered elements
Trail Making Test (TMT)
时间窗: Baseline
It evaluates selective/alternative visual attention by the time of execution (seconds)
Trail Making Test (TMT)
时间窗: 2 months
It evaluates selective/alternative visual attention by the time of execution (seconds)
Stroop Color-Word Interference Test
时间窗: Baseline
It measures processing speed and visual inhibitory control by the total number of items achieved
Stroop Color-Word Interference Test
时间窗: 2 months
It measures processing speed and visual inhibitory control by the total number of items achieved
Digit span subtests from the Wechsler Adult Intelligence Scale, version IV (WAIS-IV): Forward, Backward and Sequencing subtests
时间窗: Baseline
It evaluates span of immediate recall and verbal working memory by the total number of items achieved and the maximum number of remembered elements
Digit span subtests from the Wechsler Adult Intelligence Scale, version IV (WAIS-IV): Forward, Backward and Sequencing subtests
时间窗: 2 months
It evaluates span of immediate recall and verbal working memory by the total number of items achieved and the maximum number of remembered elements
The Acceptance and Action Questionnaire-II (AAQ-II)
时间窗: Baseline
It evaluates experiential avoidance and psychological inflexibility. It is a 7-item self-report instrument, rated on a 7-point Likert scale, with a total scale score ranging from 7 to 49. Higher scores indicate higher levels of experiential avoidance and psychological inflexibility
The Acceptance and Action Questionnaire-II (AAQ-II)
时间窗: 2 months
It evaluates experiential avoidance and psychological inflexibility. It is a 7-item self-report instrument, rated on a 7-point Likert scale, with a total scale score ranging from 7 to 49. Higher scores indicate higher levels of experiential avoidance and psychological inflexibility
The Anxiety Sensitivity Index-3 (ASI-3)
时间窗: Baseline
It measures concerns associated with possible negative consequences of anxiety-related symptoms in three dimensions (physical, cognitive and social). It is an 18-item self-report, rated on a 5-point Likert scale, with a total scale score (ranging from 0 to 72) and three 6-item subscales (Physical, Cognitive and Social Concerns, ranging from 0 to 24 points each). Higher scores indicate higher anxiety sensitivity
The Anxiety Sensitivity Index-3 (ASI-3)
时间窗: 2 months
It measures concerns associated with possible negative consequences of anxiety-related symptoms in three dimensions (physical, cognitive and social). It is an 18-item self-report, rated on a 5-point Likert scale, with a total scale score (ranging from 0 to 72) and three 6-item subscales (Physical, Cognitive and Social Concerns, ranging from 0 to 24 points each). Higher scores indicate higher anxiety sensitivity
次要结局
- The Toronto Alexithymia Scale 20-item (TAS-20)(8 months)
- The Reflective Functioning Questionnaire (RFQ-8)(8 months)
- The Five Facets of Mindfulness Questionnaire (FFMQ)(8 months)
- The World Health Organization's Quality of Life Questionnaire (WHOQOL-BREF)(8 months)
- The Hospital Anxiety and Depression Scale (HADS)(8 months)
- The World Health Organization's Quality of Life Questionnaire (WHOQOL-BREF)(2 months)
- The Five Facets of Mindfulness Questionnaire (FFMQ)(Baseline)
- The Five Facets of Mindfulness Questionnaire (FFMQ)(2 months)
- The Toronto Alexithymia Scale 20-item (TAS-20)(Baseline)
- The Toronto Alexithymia Scale 20-item (TAS-20)(2 months)
- The Reflective Functioning Questionnaire (RFQ-8)(Baseline)
- The Reflective Functioning Questionnaire (RFQ-8)(2 months)
- The Hospital Anxiety and Depression Scale (HADS)(Baseline)
- The Hospital Anxiety and Depression Scale (HADS)(2 months)
- The World Health Organization's Quality of Life Questionnaire (WHOQOL-BREF)(Baseline)
研究者
Dr. Eduardo Fernández-Jiménez
Principal Investigator
Hospital Universitario La Paz