Mindfulness-based Emotional Regulation Versus ACT in Anxiety

NCT05204264 | Unknown

• 1 other identifier: 5373
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anxiety

Keywords

Acceptance and Commitment Therapy; Mindfulness-based Emotional Regulation; Randomized clinical trial; Neuropsychology

Outcome Measures

Primary Outcomes (15)

• 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 Outcomes (15)

• The Five Facets of Mindfulness Questionnaire (FFMQ)

  Baseline

• The Five Facets of Mindfulness Questionnaire (FFMQ)

  2 months

• The Five Facets of Mindfulness Questionnaire (FFMQ)

  8 months

• The Toronto Alexithymia Scale 20-item (TAS-20)

  Baseline

• The Toronto Alexithymia Scale 20-item (TAS-20)

  2 months

Study Arms (2)

Acceptance and Commitment Therapy (ACT)

EXPERIMENTAL

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)

Mindfulness-based Emotional Regulation (MER)

EXPERIMENTAL

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)

Interventions

Acceptance and Commitment Therapy (ACT) BEHAVIORAL

This intervention uses techniques based on mindfulness, metaphors and exposition exercises both in imagination and in real contexts.

Acceptance and Commitment Therapy (ACT)

Mindfulness-based Emotional Regulation (MER) BEHAVIORAL

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.

Mindfulness-based Emotional Regulation (MER)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario La Paz: lead

Study Sites (1)

Centro de Salud Mental de Colmenar Viejo Sur

Colmenar Viejo, Madrid, 28770, Spain

RECRUITING

Related Links

• Attentional functioning after two online mindfulness-based group interventions: Acceptance and commitment therapy and a mindfulness-based emotional regulation intervention in anxiety disorders. Preliminary results.
• On gender and cognitive flexibility. The REM-ACT study: Acceptance and commitment therapy versus a mindfulness-based emotional regulation intervention in anxiety disorders. A randomized controlled trial.
• On gender and stroop effect. The REM-ACT study: Acceptance and commitment therapy versus a mindfulness-based emotional regulation intervention in anxiety disorders. A randomized controlled trial.
• TMT-B after two online mindfulness-based group interventions: Acceptance and commitment therapy and a mindfulness-based emotional regulation intervention in anxiety disorders. Preliminary results.
• On gender and TMT-A. The REM-ACT study: Acceptance and commitment therapy versus a mindfulness-based emotional regulation intervention in anxiety disorders. A randomized controlled trial.

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Eduardo Fernández-Jiménez, PhD

  Hospital Universitario La Paz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eduardo Fernández-Jiménez, PhD

CONTACT

+34630305521498401; eduferjim.psyc@gmail.com

Ana Hospital-Moreno, PhD

CONTACT

+34918456759; ana.hospital@salud.madrid.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: January 24, 2022
• Study Start: February 18, 2019
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: February 7, 2022

Record last verified: 2022-01

Locations

ES (1)