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Effects of Mindfulness Based Cognitive Therapy on Emotional Processing (MESI)

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ClinicalTrials.gov Identifier: NCT03358056
Recruitment Status : Recruiting
First Posted : November 30, 2017
Last Update Posted : November 30, 2017
Sponsor:
Information provided by (Responsible Party):
Parc de Salut Mar

Brief Summary:

Background: In the last 30 years mindfulness-based approaches have been extensively used for a variety of mental disorders, including affective disorders characterized by emotional instability. Mindfulness based cognitive therapy (MBCT) is an 8-week intervention that combines mindfulness practices with cognitive behavioural therapy. Although changes in emotional processing have been postulated as one of mindfulness mechanisms of action, the effects of mindfulness-based programs on objective tasks of emotional processing have been poorly studied.

Objective: To explore the effects of mindfulness-based cognitive therapy (MBCT) on emotional processing in a sample of individuals with emotional instability attended in a mental-health public service.

Methods: The sample (n = 30) will be recruited from public mental-health outpatient centers in Barcelona, Spain. Inclusion criteria: 1) high emotional instability defined as scores above 96 on the Difficulties in Emotion Regulation Scale (DERS), 2) age between 18 and 65 years, 4) no prior experience with mindfulness/meditation. Exclusion criteria: 1) risk of suicide (attempted suicide in the last year or current suicidal ideation). Psychotropic medication will be permitted, as long as there are no changes in dose/type during the study period.

Measures Diagnostic measures (MINI, DERS, CGI) and a complete medical register will be collected prior inclusion in the study. Additional measures on personality (ZKPQ) and temperament (Temps-A) will be collected as well.

Primary outcome:

Emotional processing task: Participants will complete the FERT task at two time points: baseline (pre-treatment) and 8 weeks (post-treatment).

Secondary outcomes:

In addition, participants will complete the following assessments (pre-and-post- treatment):

  • Depressive Symptoms (QIDS-16)
  • Anxiety Symptoms (STAI)
  • Mindfulness (FFMQ and EQ).

Treatment Mindfulness-based cognitive therapy (MBCT) is a manualized, 8 weeks-group-based training derived from mindfulness-based stress reduction (MBSR) and cognitive-behavioral therapy (CBT). In MBCT participants are trained in how to be more aware of their bodily sensations, thoughts and feelings associated with negative emotional states. Mindfulness exercises and cognitive-behavioral skills are practiced both during the sessions and through homework assignments. The program is structured in 2.30 h group sessions over 8 consecutive weeks.


Condition or disease Intervention/treatment
Unipolar Depression Anxiety Disorders Adjustment Disorders Emotional Instability Behavioral: Mindfulness-Based Cognitive Therapy

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Mindfulness Based Cognitive Therapy on Emotional Processing
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : April 1, 2018
Estimated Study Completion Date : April 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Mindfulness-based Cognitive Therapy Behavioral: Mindfulness-Based Cognitive Therapy
Mindfulness-based cognitive therapy (MBCT) is a manualized, 8 weeks-group-based training derived from mindfulness-based stress reduction (MBSR) and cognitive-behavioral therapy (CBT). In MBCT participants are trained in how to be more aware of their bodily sensations, thoughts and feelings associated with negative emotional states. Mindfulness exercises and cognitive-behavioral skills are practiced both during the sessions and through homework assignments. The program is structured in 2.30 h group sessions over 8 consecutive weeks.



Primary Outcome Measures :
  1. Facial Emotion Recognition Task [ Time Frame: 8 past weeks ]
    Computarized facial emotion recognition task


Secondary Outcome Measures :
  1. Quick Depression Inventory [ Time Frame: 1 past week ]
    Inventory for assessing depressive symptoms



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • high emotional instability defined as scores above 96 on the Difficulties in Emotion Regulation Scale (DERS)
  • diagnosis of unipolar affective disorders
  • age between 18 and 65 years
  • no prior experience with mindfulness/meditation

Exclusion Criteria:

  • risk of suicide (attempted suicide in the last year or current suicidal ideation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03358056


Contacts
Contact: Matilde Elices, Dr +34 646096104 melices@imim.es

Locations
Spain
Parc de Salut Mar Recruiting
Barcelona, Spain, 08003
Contact: Matilde Elices, Dr    +34 646096104    melices@imim.es   
Sponsors and Collaborators
Parc de Salut Mar

Responsible Party: Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT03358056     History of Changes
Other Study ID Numbers: 2017/7185/I
First Posted: November 30, 2017    Key Record Dates
Last Update Posted: November 30, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Parc de Salut Mar:
Mindfulness
Emotion
Mindfulenss-based cognitive therapy

Additional relevant MeSH terms:
Disease
Anxiety Disorders
Depressive Disorder
Adjustment Disorders
Pathologic Processes
Mental Disorders
Mood Disorders
Trauma and Stressor Related Disorders