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Trial record 1 of 1 for:    NCT02747134
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Combining Emotion Regulation and Mindfulness Skills for Preventing Depression Relapse

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ClinicalTrials.gov Identifier: NCT02747134
Recruitment Status : Completed
First Posted : April 21, 2016
Last Update Posted : April 21, 2016
Sponsor:
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Behavioral: Emotion Regulation and Mindfulness skills Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : September 2008
Actual Primary Completion Date : September 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Emotion Regulation and Mindfulness skills
A 10 week intervention including emotion regulation and mindfulness skills from dialectical behavioral therapy (DBT) was delivered.
Behavioral: Emotion Regulation and Mindfulness skills
Active Comparator: Psychoeducation
Psychoeducation consisted of 5 session in which basic information about depressive symptoms and how to prevent depression relapse was given.
Behavioral: Emotion Regulation and Mindfulness skills



Primary Outcome Measures :
  1. Hamilton Depression Rating Scale [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT02747134    
Other Study ID Numbers: EC/07/178/2678
First Posted: April 21, 2016    Key Record Dates
Last Update Posted: April 21, 2016
Last Verified: April 2016
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders