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

Study Overview
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Brief Summary
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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.

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

Conditions
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Unipolar Depression

Intervention / Treatment
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* Behavioral: Cognitive-Behavioral Therapy for Depression
* Behavioral: Exposure-Based Cognitive Therapy for Depression


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cognitive-Behavioral Therapy for Depression (CBT)<br> | Behavioral: Cognitive-Behavioral Therapy for Depression<br>* 22 weekly sessions and 2 booster session of face to face outpatient psychotherapy; focus on cognitive restructuring without emotion-focused interventions<br>|
| Experimental: Exposure-Based Cognitive Therapy for Depression (EBCT)<br> | Behavioral: Exposure-Based Cognitive Therapy for Depression<br>* 22 weekly sessions and 2 booster session of face to face outpatient psychotherapy; focus on emotion-focused interventions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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depressive episode, psychotherapy, cognitive therapy, emotional processing, RCT, exposure, dual process model, Implicit Association Test, mechanism of change