Schema Focused Therapy for Chronic Depression

NCT01153867 | Completed

• 1 other identifier: MEC 10-3-048
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Schema focused therapy (SFT) is an innovative treatment approach to chronic, lifelong problems that incorporates cognitive, behavioral, experiential and psychodynamic elements and techniques. This study will determine whether SFT is a suitable and effective treatment for chronic depression in terms of acute effects and the prevention of relapse/recurrence. The secondary aim of this study is to identify the underlying mechanisms of change in SFT that lead to recovery from depression and the prevention of future relapse/recurrence.

Conditions

Chronic Major Depressive Disorder

Keywords

Schema Focused Therapy; Chronic Depression; Mechanisms of Change

Outcome Measures

Primary Outcomes (1)

• Depressive symptom improvement

  Weekly during baseline and intervention; Monthly during follow-up

Secondary Outcomes (1)

• Depressive relapse/recurrence

  Measured at 12 month follow-up

Study Arms (1)

Schema Focused Therapy

EXPERIMENTAL

Participants will receive Schema Focused Therapy

Behavioral: Schema Focused Therapy

Interventions

Schema Focused Therapy BEHAVIORAL

SFT is a novel treatment approach to chronic, lifelong problems that incorporates cognitive, behavioral, experiential and psychodynamic elements and techniques. In the present study participants will receive up to 75 individual sessions of SFT depending on the individual progress in therapy.

Schema Focused Therapy

Eligibility Criteria

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

You may qualify if:

• Chronic MDD as defined by the DSM-IV (meeting full criteria of MDD for at least 2 years).
• Beck Depression Inventory II (BDI-II) score at screening \>=20 (moderate to severe depression)
• Can understand and speak the Dutch language
• Has internet access at home

You may not qualify if:

• Acute suicide risk
• Substance induced mood disorder
• Medical condition causes depression directly or through medication intake
• MDD with psychotic features
• DSM-IV Bipolar disorder (current or past)
• DSM-IV Psychotic disorder (current or past)
• DSM-IV alcohol or drug dependence
• Autism Spectrum Disorders (Autistic Disorder, Asperger Syndrome, Pervasive developmental disorder NOS, Rett syndrome, Childhood disintegrative disorder)
• Cluster A and Cluster B personality disorders
• Started with antidepressant medication within three months prior to initial screening. Patients who receive antidepressant medication for more than 3 months prior to the start of the study can keep taking their medication and will not be excluded from participation.
• MRI contra-indications, such as claustrophobia, metal parts in the body and, for women, current pregnancy or breastfeeding.

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Academic Community Mental Health Centre (RIAGG): collaborator

Study Sites (1)

Academic Community Mental Health Center, Riagg

Maastricht, Limburg, 6221BD, Netherlands

Location

Study Officials

• Fritz Renner, PhD

  Department of Clinical Psychological Science, Maastricht University

  PRINCIPAL INVESTIGATOR

• Marcus Huibers, PhD

  Department of Clinical Psychological Science, Maastricht University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: June 29, 2010
• First Posted: June 30, 2010
• Study Start: January 1, 2011
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: March 16, 2016

Record last verified: 2016-03

Locations

NL (1)