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

This study is ongoing, but not recruiting participants.
Sponsor:
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
  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

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 April 17, 2014