Overview

This trial is active, not recruiting.

Condition unipolar depression
Treatments cognitive-behavioral therapy for depression, exposure-based cognitive therapy for depression
Phase phase 2
Sponsor University of Zurich
Start date January 2010
End date December 2013
Trial size 142 participants
Trial identifier NCT01012856, PP00P1_ 123377

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Active Comparator)
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
22 weekly sessions and 2 booster session of face to face outpatient psychotherapy; focus on emotion-focused interventions

Primary Outcomes

Measure
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)

Secondary Outcomes

Measure
symptom impairment measured by the Brief Symptom Inventory (BSI)
time frame: 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
interpersonal problems measured by the Inventory of Interpersonal Problems (IIP)
time frame: 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
resources measured by the Bernese Inventory of Resources (RES-K)
time frame: 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
implicit self-esteem measured by the Self-Esteem Implicit Association Test (SE-IAT)
time frame: end of therapy
goal attainment measured by Goal Attainment Scaling (GAS)
time frame: end of therapy
avoidance motivation measured by the Inventory of Approach and Avoidance Motivation (IAAM)
time frame: end of therpy, 6-month follow-up
motivational incongruence measured by The Incongruence Questionnaire (INC)
time frame: end of therapy, 6-month follow-up

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Explicit and Implicit Change of Depression in Exposure-based Cognitive Therapy
Principal investigator Martin Grosse Holtforth, Professor MD
Trial information was received from ClinicalTrials.gov and was last updated in October 2012.
Information provided to ClinicalTrials.gov by University of Zurich.