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Combining Emotion Regulation and Mindfulness Skills for Preventing Depression Relapse

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Emotion Regulation and Mindfulness skills
Sponsored by
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age between 18 and 75 years
  • having a former MDD diagnosis in complete or partial remission at the time of the study as indicated by the major depressive section of the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I) and scores below 17 on the Hamilton Depression Rating Scale (HSRD)
  • having the last major depressive episode between 18 and 2 months prior to the study
  • having at least two previous depressive episodes
  • patients could continue pharmacological treatment on condition that it remained stable for at least the last two months before entering the study.

Exclusion Criteria:

  • DSM-IV-TR criteria for current MDD or any other affective disorder
  • DSM-IV-TR criteria for alcohol or drug dependence, schizophrenia or psychotic disorders
  • DSM-IV-TR criteria for personality disorders; severe physical conditions such as organic brain syndrome or neurological disease; mental retardation or cognitive impairments
  • having received any psychotherapy including cognitive-behavioral therapy in the past
  • changes in the pharmacological treatment during the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Emotion Regulation and Mindfulness skills

    Psychoeducation

    Arm Description

    A 10 week intervention including emotion regulation and mindfulness skills from dialectical behavioral therapy (DBT) was delivered.

    Psychoeducation consisted of 5 session in which basic information about depressive symptoms and how to prevent depression relapse was given.

    Outcomes

    Primary Outcome Measures

    Hamilton Depression Rating Scale

    Secondary Outcome Measures

    Full Information

    First Posted
    April 19, 2016
    Last Updated
    April 20, 2016
    Sponsor
    Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02747134
    Brief Title
    Combining Emotion Regulation and Mindfulness Skills for Preventing Depression Relapse
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2008 (undefined)
    Primary Completion Date
    September 2011 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    4. Oversight

    5. Study Description

    Brief Summary
    In the present study researchers aim to investigate the effectiveness of an intervention combining emotion regulation and mindfulness skills in a single 10-week program. A total of 75 individuals with major depressive disorder (MDD) diagnosis in complete or partial remission participated in this randomized controlled trial (RCT) comparing an intervention including emotion regulation and mindfulness skills (ER+M) with a psychoeducative program. After treatment, participants were followed for a 1-year period. Researchers results indicate that ER+M was not more effective than the treatment used with the control group in preventing depression relapse. Participants allocated to the ER+M group showed a significant decrease on global psychiatric symptoms, whereas those in the control group did not. Further studies are needed in order to better determine the combined effects of mindfulness and behavioral activation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Major Depressive Disorder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    75 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Emotion Regulation and Mindfulness skills
    Arm Type
    Experimental
    Arm Description
    A 10 week intervention including emotion regulation and mindfulness skills from dialectical behavioral therapy (DBT) was delivered.
    Arm Title
    Psychoeducation
    Arm Type
    Active Comparator
    Arm Description
    Psychoeducation consisted of 5 session in which basic information about depressive symptoms and how to prevent depression relapse was given.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Emotion Regulation and Mindfulness skills
    Primary Outcome Measure Information:
    Title
    Hamilton Depression Rating Scale
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: age between 18 and 75 years having a former MDD diagnosis in complete or partial remission at the time of the study as indicated by the major depressive section of the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I) and scores below 17 on the Hamilton Depression Rating Scale (HSRD) having the last major depressive episode between 18 and 2 months prior to the study having at least two previous depressive episodes patients could continue pharmacological treatment on condition that it remained stable for at least the last two months before entering the study. Exclusion Criteria: DSM-IV-TR criteria for current MDD or any other affective disorder DSM-IV-TR criteria for alcohol or drug dependence, schizophrenia or psychotic disorders DSM-IV-TR criteria for personality disorders; severe physical conditions such as organic brain syndrome or neurological disease; mental retardation or cognitive impairments having received any psychotherapy including cognitive-behavioral therapy in the past changes in the pharmacological treatment during the study.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    28690851
    Citation
    Elices M, Soler J, Feliu-Soler A, Carmona C, Tiana T, Pascual JC, Garcia-Palacios A, Alvarez E. Combining emotion regulation and mindfulness skills for preventing depression relapse: a randomized-controlled study. Borderline Personal Disord Emot Dysregul. 2017 Jul 5;4:13. doi: 10.1186/s40479-017-0064-6. eCollection 2017.
    Results Reference
    derived

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    Combining Emotion Regulation and Mindfulness Skills for Preventing Depression Relapse

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