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Schema Focused Therapy for Chronic Depression

Primary Purpose

Chronic Major Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Schema Focused Therapy
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Major Depressive Disorder focused on measuring Schema Focused Therapy, Chronic Depression, Mechanisms of Change

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Academic Community Mental Health Center, Riagg

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Schema Focused Therapy

Arm Description

Participants will receive Schema Focused Therapy

Outcomes

Primary Outcome Measures

Depressive symptom improvement

Secondary Outcome Measures

Depressive relapse/recurrence

Full Information

First Posted
June 29, 2010
Last Updated
March 15, 2016
Sponsor
Maastricht University Medical Center
Collaborators
Academic Community Mental Health Centre (RIAGG)
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1. Study Identification

Unique Protocol Identification Number
NCT01153867
Brief Title
Schema Focused Therapy for Chronic Depression
Official Title
Schema-Focused Therapy for Chronic Depression: Efficacy and Mechanisms of Change
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maastricht University Medical Center
Collaborators
Academic Community Mental Health Centre (RIAGG)

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Major Depressive Disorder
Keywords
Schema Focused Therapy, Chronic Depression, Mechanisms of Change

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Schema Focused Therapy
Arm Type
Experimental
Arm Description
Participants will receive Schema Focused Therapy
Intervention Type
Behavioral
Intervention Name(s)
Schema Focused Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Depressive symptom improvement
Time Frame
Weekly during baseline and intervention; Monthly during follow-up
Secondary Outcome Measure Information:
Title
Depressive relapse/recurrence
Time Frame
Measured at 12 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fritz Renner, PhD
Organizational Affiliation
Department of Clinical Psychological Science, Maastricht University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marcus Huibers, PhD
Organizational Affiliation
Department of Clinical Psychological Science, Maastricht University
Official's Role
Study Director
Facility Information:
Facility Name
Academic Community Mental Health Center, Riagg
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6221BD
Country
Netherlands

12. IPD Sharing Statement

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Schema Focused Therapy for Chronic Depression

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