Trial record 20 of 26 for:    Open Studies | "Dysthymic Disorder"

Schema Focused Therapy for Chronic Depression

This study is currently recruiting participants.
Verified April 2011 by Maastricht University Medical Center
Sponsor:
Collaborator:
Academic Community Mental Health Center, Riagg
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01153867
First received: June 29, 2010
Last updated: April 12, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention
Chronic Major Depressive Disorder
Behavioral: Schema Focused Therapy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Schema-Focused Therapy for Chronic Depression: Efficacy and Mechanisms of Change

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Depressive symptom improvement [ Time Frame: Weekly during baseline and intervention; Monthly during follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Depressive relapse/recurrence [ Time Frame: Measured at 12 month follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: January 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01153867

Contacts
Contact: Fritz Renner, MSc. +31(0)433881594 fritz.renner@maastrichtuniversity.nl
Contact: Marcus Huibers, PhD +31(0)433881228 m.huibers@maastrichtuniversity.nl

Locations
Netherlands
Academic Community Mental Health Center, Riagg Recruiting
Maastricht, Limburg, Netherlands, 6221BD
Contact: Marcus Huibers, PhD    +31(0)433881228    m.huibers@maastrichtuniversity.nl   
Sponsors and Collaborators
Maastricht University Medical Center
Academic Community Mental Health Center, Riagg
Investigators
Principal Investigator: Fritz Renner, MSc. Department of Clinical Psychological Science, Maastricht University
Study Director: Marcus Huibers, PhD Department of Clinical Psychological Science, Maastricht University
  More Information

No publications provided

Responsible Party: Fritz Renner, Department of Clinical Psychological Science, Maastricht University
ClinicalTrials.gov Identifier: NCT01153867     History of Changes
Other Study ID Numbers: MEC 10-3-048
Study First Received: June 29, 2010
Last Updated: April 12, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
Schema Focused Therapy
Chronic Depression
Mechanisms of Change

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Dysthymic Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 22, 2014