Randomized Clinical Trial of an Exposure-based Cognitive Therapy for Depression

October 30, 2012 updated by: University of Zurich

Explicit and Implicit Change of Depression in Exposure-based Cognitive Therapy

The purpose of this study is to investigate, if exposure-based cognitive therapy (EBCT) is at least as effective as the established cognitive-behavioral therapy and more effective in its long-term efficacy. Moreover the mechanisms of change of the EBCT are investigated.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

142

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • ZH
      • Zurich, ZH, Switzerland, 8050
        • University of Zurich, Department of Psychology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Major Depressive Disorder according to DSM-IV as main diagnosis
  • minimum standardized depression scores (BDI >= 17; HAMD >=13)
  • minimum age of 18 years
  • informed consent to participate voluntarily in the study
  • sufficient German language skills

Exclusion Criteria:

  • acute suicidality
  • depressive disorder with mood-incongruent psychotic features
  • chronic depressive disorder
  • organic cause of depression
  • drug-induced depression
  • bipolar disorder
  • diagnosis of schizophrenia, schizophreniform, schizoaffective disorders, and/or psychosis NOS
  • comorbid dysthymia, psychotic disorder (acute or anamnestic), dementia, substance dependence, schizotypal/ borderline/ or antisocial personality disorder
  • psychopharmacological treatment other than antidepressants
  • antidepressant medication, if it is changed within one month prior to the beginning of psychotherapy
  • other simultaneous psychological treatments

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cognitive-Behavioral Therapy for Depression (CBT)
Behavioral: Cognitive-Behavioral Therapy for Depression
22 weekly sessions and 2 booster session of face to face outpatient psychotherapy; focus on cognitive restructuring without emotion-focused interventions
Experimental: Exposure-Based Cognitive Therapy for Depression (EBCT)
Behavioral: Exposure-Based Cognitive Therapy for Depression
22 weekly sessions and 2 booster session of face to face outpatient psychotherapy; focus on emotion-focused interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
severity of depressive symptoms measured by the Beck-Depression-Inventory (BDI-II)
Time Frame: end of therapy, 6 month after end of therapy (follow up)
end of therapy, 6 month after end of therapy (follow up)

Secondary Outcome Measures

Outcome Measure
Time Frame
symptom impairment measured by the Brief Symptom Inventory (BSI)
Time Frame: end of therapy, 6-month follow up
end of therapy, 6-month follow up
quality of life measured by the WHO Quality of Life-BREF (WHOQOL-BREF)
Time Frame: end of therapy, 6-month follow-up
end of therapy, 6-month follow-up
interpersonal problems measured by the Inventory of Interpersonal Problems (IIP)
Time Frame: end of therapy, 6-month follow-up
end of therapy, 6-month follow-up
avoidance measured by the Cognitive-Behavioral Avoidance Scales (CBAS)
Time Frame: end of therapy, 6-month follow-up
end of therapy, 6-month follow-up
resources measured by the Bernese Inventory of Resources (RES-K)
Time Frame: end of therapy, 6-month follow-up
end of therapy, 6-month follow-up
explicit self-esteem measured by the Rosenberg self-esteem scale (RSES)
Time Frame: end of therapy, 6-month follow up
end of therapy, 6-month follow up
implicit self-esteem measured by the Self-Esteem Implicit Association Test (SE-IAT)
Time Frame: end of therapy
end of therapy
goal attainment measured by Goal Attainment Scaling (GAS)
Time Frame: end of therapy
end of therapy
avoidance motivation measured by the Inventory of Approach and Avoidance Motivation (IAAM)
Time Frame: end of therpy, 6-month follow-up
end of therpy, 6-month follow-up
motivational incongruence measured by The Incongruence Questionnaire (INC)
Time Frame: end of therapy, 6-month follow-up
end of therapy, 6-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Investigators

  • Principal Investigator: Martin Grosse Holtforth, Professor MD, University of Zurich, Department of Psychology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Anticipated)

December 1, 2013

Study Completion (Anticipated)

March 1, 2014

Study Registration Dates

First Submitted

November 11, 2009

First Submitted That Met QC Criteria

November 11, 2009

First Posted (Estimate)

November 13, 2009

Study Record Updates

Last Update Posted (Estimate)

October 31, 2012

Last Update Submitted That Met QC Criteria

October 30, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PP00P1_ 123377

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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