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

Explicit and Implicit Change of Depression in Exposure-based Cognitive Therapy

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01012856
Enrollment
142
Registered
2009-11-13
Start date
2010-01-31
Completion date
2014-03-31
Last updated
2012-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unipolar Depression

Keywords

depressive episode, psychotherapy, cognitive therapy, emotional processing, RCT, exposure, dual process model, Implicit Association Test, mechanism of change

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.

Interventions

BEHAVIORALCognitive-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

BEHAVIORALExposure-Based Cognitive Therapy for Depression

22 weekly sessions and 2 booster session of face to face outpatient psychotherapy; focus on emotion-focused interventions

Sponsors

University of Zurich
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
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
symptom impairment measured by the Brief Symptom Inventory (BSI)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
explicit self-esteem measured by the Rosenberg self-esteem scale (RSES)end of therapy, 6-month follow up

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026