Clinical trial NCT05204264: Mindfulness-based Emotional Regulation Versus ACT in Anxiety
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety
Keywords: Acceptance and Commitment Therapy
Mindfulness-based Emotional Regulation
Randomized clinical trial
Neuropsychology
Lead sponsor: Hospital Universitario La Paz
Sponsor class: OTHER
First posted: 2022-01-24
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Trail Making Test (TMT)
timeFrame: Baseline
measure: Trail Making Test (TMT)
timeFrame: 2 months
measure: Trail Making Test (TMT)
timeFrame: 8 months
measure: Stroop Color-Word Interference Test
timeFrame: Baseline
measure: Stroop Color-Word Interference Test
timeFrame: 2 months
measure: Stroop Color-Word Interference Test
timeFrame: 8 months
measure: Digit span subtests from the Wechsler Adult Intelligence Scale, version IV (WAIS-IV): Forward, Backward and Sequencing subtests
timeFrame: Baseline
measure: Digit span subtests from the Wechsler Adult Intelligence Scale, version IV (WAIS-IV): Forward, Backward and Sequencing subtests
timeFrame: 2 months
measure: Digit span subtests from the Wechsler Adult Intelligence Scale, version IV (WAIS-IV): Forward, Backward and Sequencing subtests
timeFrame: 8 months
measure: The Acceptance and Action Questionnaire-II (AAQ-II)
timeFrame: Baseline
measure: The Acceptance and Action Questionnaire-II (AAQ-II)
timeFrame: 2 months
measure: The Acceptance and Action Questionnaire-II (AAQ-II)
timeFrame: 8 months
measure: The Anxiety Sensitivity Index-3 (ASI-3)
timeFrame: Baseline
measure: The Anxiety Sensitivity Index-3 (ASI-3)
timeFrame: 2 months
measure: The Anxiety Sensitivity Index-3 (ASI-3)
timeFrame: 8 months
Secondary outcomes:
measure: The Five Facets of Mindfulness Questionnaire (FFMQ)
timeFrame: Baseline
measure: The Five Facets of Mindfulness Questionnaire (FFMQ)
timeFrame: 2 months
measure: The Five Facets of Mindfulness Questionnaire (FFMQ)
timeFrame: 8 months
measure: The Toronto Alexithymia Scale 20-item (TAS-20)
timeFrame: Baseline
measure: The Toronto Alexithymia Scale 20-item (TAS-20)
timeFrame: 2 months
measure: The Toronto Alexithymia Scale 20-item (TAS-20)
timeFrame: 8 months
measure: The Reflective Functioning Questionnaire (RFQ-8)
timeFrame: Baseline
measure: The Reflective Functioning Questionnaire (RFQ-8)
timeFrame: 2 months
measure: The Reflective Functioning Questionnaire (RFQ-8)
timeFrame: 8 months
measure: The Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline
measure: The Hospital Anxiety and Depression Scale (HADS)
timeFrame: 2 months
measure: The Hospital Anxiety and Depression Scale (HADS)
timeFrame: 8 months
measure: The World Health Organization's Quality of Life Questionnaire (WHOQOL-BREF)
timeFrame: Baseline
measure: The World Health Organization's Quality of Life Questionnaire (WHOQOL-BREF)
timeFrame: 2 months
measure: The World Health Organization's Quality of Life Questionnaire (WHOQOL-BREF)
timeFrame: 8 months
Other outcomes:
Locations:
city: Colmenar Viejo
country: Spain
facility: Centro de Salud Mental de Colmenar Viejo Sur
state: Madrid
Study officials:
affiliation: Hospital Universitario La Paz
name: Eduardo Fernández-Jiménez, PhD
role: PRINCIPAL_INVESTIGATOR
References: