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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014