Mindfulness-based Emotional Regulation Versus ACT in Anxiety

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Anxiety

Intervention / Treatment
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* Behavioral: Acceptance and Commitment Therapy (ACT)
* Behavioral: Mindfulness-based Emotional Regulation (MER)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acceptance and Commitment Therapy (ACT)<br>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. | Behavioral: Acceptance and Commitment Therapy (ACT)<br>* This intervention uses techniques based on mindfulness, metaphors and exposition exercises both in imagination and in real contexts.<br>|
| Experimental: Mindfulness-based Emotional Regulation (MER)<br>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. | Behavioral: Mindfulness-based Emotional Regulation (MER)<br>* This intervention includes both formal practices of body scan meditation, standing / sitting Hatha yoga, meditations focused on the breath or other objects of attention, exercises of benevolence or kindness with affection (loving-kindness); as well as informal mindfulness practices in activities of daily living.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trail Making Test (TMT) | It evaluates selective/alternative visual attention by the time of execution (seconds) | Baseline | 
| Trail Making Test (TMT) | It evaluates selective/alternative visual attention by the time of execution (seconds) | 2 months | 
| Trail Making Test (TMT) | It evaluates selective/alternative visual attention by the time of execution (seconds) | 8 months | 
| Stroop Color-Word Interference Test | It measures processing speed and visual inhibitory control by the total number of items achieved | Baseline | 
| Stroop Color-Word Interference Test | It measures processing speed and visual inhibitory control by the total number of items achieved | 2 months | 
| Stroop Color-Word Interference Test | It measures processing speed and visual inhibitory control by the total number of items achieved | 8 months | 
| Digit span subtests from the Wechsler Adult Intelligence Scale, version IV (WAIS-IV): Forward, Backward and Sequencing subtests | It evaluates span of immediate recall and verbal working memory by the total number of items achieved and the maximum number of remembered elements | Baseline | 
| Digit span subtests from the Wechsler Adult Intelligence Scale, version IV (WAIS-IV): Forward, Backward and Sequencing subtests | It evaluates span of immediate recall and verbal working memory by the total number of items achieved and the maximum number of remembered elements | 2 months | 
| Digit span subtests from the Wechsler Adult Intelligence Scale, version IV (WAIS-IV): Forward, Backward and Sequencing subtests | It evaluates span of immediate recall and verbal working memory by the total number of items achieved and the maximum number of remembered elements | 8 months | 
| The Acceptance and Action Questionnaire-II (AAQ-II) | 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 | Baseline | 
| The Acceptance and Action Questionnaire-II (AAQ-II) | 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 | 2 months | 
| The Acceptance and Action Questionnaire-II (AAQ-II) | 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 | 8 months | 
| The Anxiety Sensitivity Index-3 (ASI-3) | 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 | Baseline | 
| The Anxiety Sensitivity Index-3 (ASI-3) | 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 | 2 months | 
| The Anxiety Sensitivity Index-3 (ASI-3) | 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 | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Five Facets of Mindfulness Questionnaire (FFMQ) | It is a self-report instrument of 39 items, rated on a 5-point Likert scale, that are grouped into both a total scale score (with a mean score ranging from 1 to 5) and five specific subscales: Observing (8 items), Describing (8 items), Acting with awareness (8 items), Non-judgment (8 items), and Non-reactivity (7 items). Higher values indicate higher levels in each domain | Baseline | 
| The Five Facets of Mindfulness Questionnaire (FFMQ) | It is a self-report instrument of 39 items, rated on a 5-point Likert scale, that are grouped into both a total scale score (with a mean score ranging from 1 to 5) and five specific subscales: Observing (8 items), Describing (8 items), Acting with awareness (8 items), Non-judgment (8 items), and Non-reactivity (7 items). Higher values indicate higher levels in each domain | 2 months | 
| The Five Facets of Mindfulness Questionnaire (FFMQ) | It is a self-report instrument of 39 items, rated on a 5-point Likert scale, that are grouped into both a total scale score (with a mean score ranging from 1 to 5) and five specific subscales: Observing (8 items), Describing (8 items), Acting with awareness (8 items), Non-judgment (8 items), and Non-reactivity (7 items). Higher values indicate higher levels in each domain | 8 months | 
| The Toronto Alexithymia Scale 20-item (TAS-20) | It is a self-report instrument that measures both a global factor of alexithymia, and three specific domains: Difficulty in Identifying Feelings (7 items), Difficulty in Describing Feelings (5 items) and Externally Oriented Thinking (8 items). Items are rated on a 5-point Likert scale. The total scale score ranges between 20 and 100, with higher scores indicating greater level of alexithymia | Baseline | 
| The Toronto Alexithymia Scale 20-item (TAS-20) | It is a self-report instrument that measures both a global factor of alexithymia, and three specific domains: Difficulty in Identifying Feelings (7 items), Difficulty in Describing Feelings (5 items) and Externally Oriented Thinking (8 items). Items are rated on a 5-point Likert scale. The total scale score ranges between 20 and 100, with higher scores indicating greater level of alexithymia | 2 months | 
| The Toronto Alexithymia Scale 20-item (TAS-20) | It is a self-report instrument that measures both a global factor of alexithymia, and three specific domains: Difficulty in Identifying Feelings (7 items), Difficulty in Describing Feelings (5 items) and Externally Oriented Thinking (8 items). Items are rated on a 5-point Likert scale. The total scale score ranges between 20 and 100, with higher scores indicating greater level of alexithymia | 8 months | 
| The Reflective Functioning Questionnaire (RFQ-8) | It is an 8-item self-report instrument, rated on a 7-point Likert scale, that assesses the degree of certainty or uncertainty about their own or someone else's mental states. It includes two subscales (with a double-scoring procedure): Uncertainty about mental states (5 items, with range 0-3) and Certainty about mental states (6 items, with range 0-2). High levels of certainty about mental states indicate hypermentalizing and high levels of uncertainty indicate hypomentalizing | Baseline | 
| The Reflective Functioning Questionnaire (RFQ-8) | It is an 8-item self-report instrument, rated on a 7-point Likert scale, that assesses the degree of certainty or uncertainty about their own or someone else's mental states. It includes two subscales (with a double-scoring procedure): Uncertainty about mental states (5 items, with range 0-3) and Certainty about mental states (6 items, with range 0-2). High levels of certainty about mental states indicate hypermentalizing and high levels of uncertainty indicate hypomentalizing | 2 months | 
| The Reflective Functioning Questionnaire (RFQ-8) | It is an 8-item self-report instrument, rated on a 7-point Likert scale, that assesses the degree of certainty or uncertainty about their own or someone else's mental states. It includes two subscales (with a double-scoring procedure): Uncertainty about mental states (5 items, with range 0-3) and Certainty about mental states (6 items, with range 0-2). High levels of certainty about mental states indicate hypermentalizing and high levels of uncertainty indicate hypomentalizing | 8 months | 
| The Hospital Anxiety and Depression Scale (HADS) | It measures anxious and depressive symptomatology. It is a 14-item self-report, rated on a 4-point Likert scale, with a total score (ranging from 0 to 42) and two subscales (7 items each, ranging from 0-21) | Baseline | 
| The Hospital Anxiety and Depression Scale (HADS) | It measures anxious and depressive symptomatology. It is a 14-item self-report, rated on a 4-point Likert scale, with a total score (ranging from 0 to 42) and two subscales (7 items each, ranging from 0-21) | 2 months | 
| The Hospital Anxiety and Depression Scale (HADS) | It measures anxious and depressive symptomatology. It is a 14-item self-report, rated on a 4-point Likert scale, with a total score (ranging from 0 to 42) and two subscales (7 items each, ranging from 0-21) | 8 months | 
| The World Health Organization's Quality of Life Questionnaire (WHOQOL-BREF) | It is a self-report instrument of 26 items grouped into general health questions (2 items) and four factors: Physical Health (7 items), Psychological Health (6 items), Social Relations (3 items) and Environment (8 items), ranging from 0 to 100 points. Higher scores in each domain indicate higher level of satisfaction | Baseline | 
| The World Health Organization's Quality of Life Questionnaire (WHOQOL-BREF) | It is a self-report instrument of 26 items grouped into general health questions (2 items) and four factors: Physical Health (7 items), Psychological Health (6 items), Social Relations (3 items) and Environment (8 items), ranging from 0 to 100 points. Higher scores in each domain indicate higher level of satisfaction | 2 months | 
| The World Health Organization's Quality of Life Questionnaire (WHOQOL-BREF) | It is a self-report instrument of 26 items grouped into general health questions (2 items) and four factors: Physical Health (7 items), Psychological Health (6 items), Social Relations (3 items) and Environment (8 items), ranging from 0 to 100 points. Higher scores in each domain indicate higher level of satisfaction | 8 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acceptance and Commitment Therapy, Mindfulness-based Emotional Regulation, Randomized clinical trial, Neuropsychology