Combining Emotion Regulation and Mindfulness Skills for Preventing Depression Relapse

NCT02747134 | Completed

• 1 other identifier: EC/07/178/2678
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Hamilton Depression Rating Scale

  1 year

Study Arms (2)

Emotion Regulation and Mindfulness skills

EXPERIMENTAL

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

Behavioral: Emotion Regulation and Mindfulness skills

Psychoeducation

ACTIVE COMPARATOR

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

Interventions

Emotion Regulation and Mindfulness skills BEHAVIORAL

Emotion Regulation and Mindfulness skills; Psychoeducation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Related Publications (1)

• 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.

  PMID: 28690851 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2016
• First Posted: April 21, 2016
• Study Start: September 1, 2008
• Primary Completion: September 1, 2011
• Last Updated: April 21, 2016

Record last verified: 2016-04