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

Phase 2

• Conditions: Unipolar Depression
• Interventions: Behavioral: Cognitive-Behavioral Therapy for Depression; Behavioral: Exposure-Based Cognitive Therapy for Depression

• Registration Number: NCT01012856
• Lead Sponsor: University of Zurich

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-11-11
• Study First Submitted QC: 2009-11-11
• Study First Posted: 2009-11-13
• Study Start: 2010-01
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-30
• Last Update Posted: 2012-10-31
• Primary Completion: 2013-12
• Study Completion: 2014-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 142

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive-Behavioral Therapy for Depression (CBT)	Cognitive-Behavioral Therapy for Depression	-
Exposure-Based Cognitive Therapy for Depression (EBCT)	Exposure-Based Cognitive Therapy for Depression	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Zurich, Department of Psychology; 🇨🇭 Zurich, ZH, Switzerland