Schema Focused Therapy for Chronic Depression

Schema-Focused Therapy for Chronic Depression: Efficacy and Mechanisms of Change

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.

Study Overview

• Status: Completed
• Conditions: Chronic Major Depressive Disorder
• Intervention / Treatment: Behavioral: Schema Focused Therapy

Detailed Description

A single-case series design with multiple randomized baselines across participants will be used in this study. The study will last approximately 36 months and comprises three phases. The first phase is a 6-12 weeks waiting list/baseline phase during which participants will be repeatedly assessed with the main outcome measures and putative mediators. In the second phase participants will receive up to 75 individual sessions of SFT for chronic depression depending on the individual progress in therapy. Upon completion of the intervention phase, participants will have monthly follow-up assessments for the next 12 months.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Limburg
    • Maastricht, Limburg, Netherlands, 6221BD
      • Academic Community Mental Health Center, Riagg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Schema Focused Therapy; Participants will receive Schema Focused Therapy	Behavioral: Schema Focused Therapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Depressive symptom improvement	Weekly during baseline and intervention; Monthly during follow-up

Secondary Outcome Measures

Outcome Measure	Time Frame
Depressive relapse/recurrence	Measured at 12 month follow-up

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Collaborators: Academic Community Mental Health Centre (RIAGG)
• Investigators: Principal Investigator: Fritz Renner, PhD, Department of Clinical Psychological Science, Maastricht University; Study Director: Marcus Huibers, PhD, Department of Clinical Psychological Science, Maastricht University

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: June 29, 2010
• First Submitted That Met QC Criteria: June 29, 2010
• First Posted (Estimate): June 30, 2010

Study Record Updates

• Last Update Posted (Estimate): March 16, 2016
• Last Update Submitted That Met QC Criteria: March 15, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Mechanisms of Change; Chronic Depression; Schema Focused Therapy
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: MEC 10-3-048