AnxietyMER-ACTNCT05204264
Mindfulness-based Emotional Regulation Versus ACT in Anxiety
A study testing Acceptance and Commitment Therapy (ACT) and Mindfulness-based Emotional Regulation (MER) in people with Anxiety, run by Hospital Universitario La Paz at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anxiety
- What is being tested?
- Acceptance and Commitment Therapy (ACT) and Mindfulness-based Emotional Regulation (MER)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteSpain
- Study dates
- 18 Feb 2019to Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Centro de Salud Mental de Colmenar Viejo Sur
Colmenar Viejo, Madrid, 28770
Ana Hospital-Moreno, PhD, +34918456759, ana.hospital@salud.madrid.org
Emma Vidal-Bermejo, MSc, +34918456759, emma.vidal@salud.madrid.org
About this study
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
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.
Read more
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
- Being tested
- Acceptance and Commitment Therapy (ACT), Mindfulness-based Emotional Regulation (MER)
- Keywords
- Acceptance and Commitment Therapy, Mindfulness-based Emotional Regulation, Randomized clinical trial, Neuropsychology
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment Therapy (ACT)Behavioural
This intervention uses techniques based on mindfulness, metaphors and exposition exercises both in imagination and in real contexts.
Mindfulness-based Emotional Regulation (MER)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Mindfulness-based Emotional Regulation (MER) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trail Making Test (TMT)
It evaluates selective/alternative visual attention by the time of execution (seconds)
Measured: Baseline
Trail Making Test (TMT)
It evaluates selective/alternative visual attention by the time of execution (seconds)
Measured: 2 months
Trail Making Test (TMT)
It evaluates selective/alternative visual attention by the time of execution (seconds)
Measured: 8 months
Stroop Color-Word Interference Test
It measures processing speed and visual inhibitory control by the total number of items achieved
Measured: Baseline
Stroop Color-Word Interference Test
It measures processing speed and visual inhibitory control by the total number of items achieved
Measured: 2 months
Stroop Color-Word Interference Test
It measures processing speed and visual inhibitory control by the total number of items achieved
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 8 months
Secondary outcomes (15)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start18 Feb 2019
- Primary completionSep 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Eduardo Fernández-Jiménez, Hospital Universitario La Paz
- Investigators
- Eduardo Fernández-Jiménez, PhD, Principal investigator, Hospital Universitario La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05204264
- Sponsor's protocol ID
- 5373
- Acronym
- MER-ACT
- Status last verified
- Jan 2022
- First submitted
- 11 Jan 2022
- Last updated
- 7 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05204264
- Acronym / sponsor ID
- MER-ACT / 5373
- Conditions
- Anxiety
- Keywords
- Acceptance and Commitment Therapy, Mindfulness-based Emotional Regulation, Randomized clinical trial, Neuropsychology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Hospital Universitario La PazUniversity, hospital or other
- Study start
- 18 Feb 2019 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 24 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acceptance and Commitment Therapy (ACT) | Experimental | Behavioral: 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. |
| Mindfulness-based Emotional Regulation (MER) | Experimental | 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptance and Commitment Therapy (ACT)This intervention uses techniques based on mindfulness, metaphors and exposition exercises both in imagination and in real contexts. | Behavioural | Acceptance and Commitment Therapy (ACT) |
| 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. | Behavioural | Mindfulness-based Emotional Regulation (MER) |
Primary outcome
Trail Making Test (TMT)
Time frame: Baseline
It evaluates selective/alternative visual attention by the time of execution (seconds)
Trail Making Test (TMT)
Time frame: 2 months
It evaluates selective/alternative visual attention by the time of execution (seconds)
Trail Making Test (TMT)
Time frame: 8 months
It evaluates selective/alternative visual attention by the time of execution (seconds)
Stroop Color-Word Interference Test
Time frame: Baseline
It measures processing speed and visual inhibitory control by the total number of items achieved
Stroop Color-Word Interference Test
Time frame: 2 months
It measures processing speed and visual inhibitory control by the total number of items achieved
Stroop Color-Word Interference Test
Time frame: 8 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
Time frame: 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
Time frame: 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
Digit span subtests from the Wechsler Adult Intelligence Scale, version IV (WAIS-IV): Forward, Backward and Sequencing subtests
Time frame: 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
The Acceptance and Action Questionnaire-II (AAQ-II)
Time frame: 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)
Time frame: 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 Acceptance and Action Questionnaire-II (AAQ-II)
Time frame: 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
The Anxiety Sensitivity Index-3 (ASI-3)
Time frame: 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)
Time frame: 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
The Anxiety Sensitivity Index-3 (ASI-3)
Time frame: 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
15 secondary outcomes
The Five Facets of Mindfulness Questionnaire (FFMQ)
Time frame: Baseline
The Five Facets of Mindfulness Questionnaire (FFMQ)
Time frame: 2 months
The Five Facets of Mindfulness Questionnaire (FFMQ)
Time frame: 8 months
The Toronto Alexithymia Scale 20-item (TAS-20)
Time frame: Baseline
The Toronto Alexithymia Scale 20-item (TAS-20)
Time frame: 2 months
The Toronto Alexithymia Scale 20-item (TAS-20)
Time frame: 8 months
The Reflective Functioning Questionnaire (RFQ-8)
Time frame: Baseline
The Reflective Functioning Questionnaire (RFQ-8)
Time frame: 2 months
The Reflective Functioning Questionnaire (RFQ-8)
Time frame: 8 months
The Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline
The Hospital Anxiety and Depression Scale (HADS)
Time frame: 2 months
The Hospital Anxiety and Depression Scale (HADS)
Time frame: 8 months
The World Health Organization's Quality of Life Questionnaire (WHOQOL-BREF)
Time frame: Baseline
The World Health Organization's Quality of Life Questionnaire (WHOQOL-BREF)
Time frame: 2 months
The World Health Organization's Quality of Life Questionnaire (WHOQOL-BREF)
Time frame: 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2022.
- 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.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- 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.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eduardo Fernández-Jiménez, PhD principal investigator
Hospital Universitario La Paz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy (ACT) and Mindfulness-based Emotional Regulation (MER) in people with Anxiety, run by Hospital Universitario La Paz at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eduardo Fernández-Jiménez, PhD (+34630305521498401, eduferjim.psyc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trail Making Test (TMT) (time frame: Baseline). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2022.