Combining Emotion Regulation and Mindfulness Skills for Preventing Depression Relapse

Major Depressive Disorder Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02747134
• Other study ID #: EC/07/178/2678
• Status: Completed
• Phase: N/A
• First received: April 19, 2016
• Last updated: April 20, 2016
• Start date: September 2008

Study information

• Verified date: April 2016
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Behavioral:
• Emotion Regulation and Mindfulness skills

Locations

Country	Name	City	State
n/a

Sponsors (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Depression Rating Scale		1 year	No