Randomized Clinical Trial of an Exposure-based Cognitive Therapy for Depression
This study is ongoing, but not recruiting participants.
Sponsor:
University of Zurich
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01012856
First received: November 11, 2009
Last updated: October 30, 2012
Last verified: October 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Unipolar Depression |
Behavioral: Cognitive-Behavioral Therapy for Depression Behavioral: Exposure-Based Cognitive Therapy for Depression |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Explicit and Implicit Change of Depression in Exposure-based Cognitive Therapy |
Resource links provided by NLM:
Further study details as provided by University of Zurich:
Primary Outcome Measures:
- 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) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- symptom impairment measured by the Brief Symptom Inventory (BSI) [ Time Frame: end of therapy, 6-month follow up ] [ Designated as safety issue: No ]
- quality of life measured by the WHO Quality of Life-BREF (WHOQOL-BREF) [ Time Frame: end of therapy, 6-month follow-up ] [ Designated as safety issue: No ]
- interpersonal problems measured by the Inventory of Interpersonal Problems (IIP) [ Time Frame: end of therapy, 6-month follow-up ] [ Designated as safety issue: No ]
- avoidance measured by the Cognitive-Behavioral Avoidance Scales (CBAS) [ Time Frame: end of therapy, 6-month follow-up ] [ Designated as safety issue: No ]
- resources measured by the Bernese Inventory of Resources (RES-K) [ Time Frame: end of therapy, 6-month follow-up ] [ Designated as safety issue: No ]
- explicit self-esteem measured by the Rosenberg self-esteem scale (RSES) [ Time Frame: end of therapy, 6-month follow up ] [ Designated as safety issue: No ]
- implicit self-esteem measured by the Self-Esteem Implicit Association Test (SE-IAT) [ Time Frame: end of therapy ] [ Designated as safety issue: No ]
- goal attainment measured by Goal Attainment Scaling (GAS) [ Time Frame: end of therapy ] [ Designated as safety issue: No ]
- avoidance motivation measured by the Inventory of Approach and Avoidance Motivation (IAAM) [ Time Frame: end of therpy, 6-month follow-up ] [ Designated as safety issue: No ]
- motivational incongruence measured by The Incongruence Questionnaire (INC) [ Time Frame: end of therapy, 6-month follow-up ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 142 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01012856
Locations
| Switzerland | |
| University of Zurich, Department of Psychology | |
| Zurich, ZH, Switzerland, 8050 | |
Sponsors and Collaborators
University of Zurich
Investigators
| Principal Investigator: | Martin Grosse Holtforth, Professor MD | University of Zurich, Department of Psychology |
More Information
Additional Information:
Publications:
| Responsible Party: | University of Zurich |
| ClinicalTrials.gov Identifier: | NCT01012856 History of Changes |
| Other Study ID Numbers: | PP00P1_ 123377 |
| Study First Received: | November 11, 2009 |
| Last Updated: | October 30, 2012 |
| Health Authority: | Switzerland: Federal Office of Public Health |
Keywords provided by University of Zurich:
|
depressive episode psychotherapy cognitive therapy emotional processing RCT |
exposure dual process model Implicit Association Test mechanism of change |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders |
ClinicalTrials.gov processed this record on June 18, 2013