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Schema Focused Therapy for Chronic Depression

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ClinicalTrials.gov Identifier: NCT01153867
Recruitment Status : Completed
First Posted : June 30, 2010
Last Update Posted : March 16, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Chronic Major Depressive Disorder 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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Schema-Focused Therapy for Chronic Depression: Efficacy and Mechanisms of Change
Study Start Date : January 2011
Primary Completion Date : January 2016
Study Completion Date : January 2016
Arms and Interventions

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.


Outcome Measures

Primary Outcome Measures :
  1. Depressive symptom improvement [ Time Frame: Weekly during baseline and intervention; Monthly during follow-up ]

Secondary Outcome Measures :
  1. Depressive relapse/recurrence [ Time Frame: Measured at 12 month follow-up ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01153867


Locations
Netherlands
Academic Community Mental Health Center, Riagg
Maastricht, Limburg, Netherlands, 6221BD
Sponsors and Collaborators
Maastricht University Medical Center
Academic Community Mental Health Center, 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
More Information

Responsible Party: Fritz Renner, Dr, Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01153867     History of Changes
Other Study ID Numbers: MEC 10-3-048
First Posted: June 30, 2010    Key Record Dates
Last Update Posted: March 16, 2016
Last Verified: March 2016

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

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