Mindfulness-based Emotional Regulation Versus ACT in Anxiety

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-18

Study Completion Date

2023-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Wait List Controlled Trial of Brief ACT and Brief MBSR-informed Group Interventions for Anxiety in a University Setting

NCT04236505

Anxiety Stress

COMPLETED NA

Randomized Clinical Trial of a Mindfulness Based Intervention in Generalized Anxiety Disorder

NCT03072264

Generalized Anxiety Disorder

COMPLETED NA

Mindfulness-based and Compassion-based Interventions in Anxious-Depressive Symptomatology in Mental Health Services

NCT03425487

Anxious-Depressive

COMPLETED NA

Mindfulness App Versus Mindfulness-based Intervention for Healthcare Students

NCT03712319

Students

COMPLETED NA

Efficacy of 8 vs 4 Sessions Mindfulness-based Programs in a Non-clinical Population

NCT02643927

Healthy Subjects

COMPLETED EARLY_PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anxiety

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Acceptance and Commitment Therapy (ACT)

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

Mindfulness-based Emotional Regulation (MER)

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Acceptance and Commitment Therapy (ACT)

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

Intervention Type BEHAVIORAL

Mindfulness-based Emotional Regulation (MER)

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No