Combining Emotion Regulation and Mindfulness Skills for Preventing Depression Relapse

Not Applicable

Completed

• Conditions: Major Depressive Disorder
• Interventions: Behavioral: Emotion Regulation and Mindfulness skills

• Registration Number: NCT02747134
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Primary Completion: 2011-09
• Status Verified: 2016-04
• Study First Submitted: 2016-04-19
• Study First Submitted QC: 2016-04-20
• Last Update Submitted: 2016-04-20
• Study First Posted: 2016-04-21
• Last Update Posted: 2016-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Hamilton Depression Rating Scale	1 year