Combining Emotion Regulation and Mindfulness Skills for Preventing Depression Relapse

NCT ID: NCT02747134

Last Updated: 2016-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Emotion Regulation and Mindfulness skills

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

Group Type EXPERIMENTAL

Emotion Regulation and Mindfulness skills

Intervention Type BEHAVIORAL

Psychoeducation

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

Group Type ACTIVE_COMPARATOR

Emotion Regulation and Mindfulness skills

Intervention Type BEHAVIORAL

Interventions

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Emotion Regulation and Mindfulness skills

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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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.

Reference Type DERIVED
PMID: 28690851 (View on PubMed)

Other Identifiers

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EC/07/178/2678

Identifier Type: -

Identifier Source: org_study_id

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