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

Primary Purpose

Unipolar Depression

Status

Unknown status

Phase

Phase 2

Locations

Switzerland

Study Type

Interventional

Intervention

Cognitive-Behavioral Therapy for Depression

Exposure-Based Cognitive Therapy for Depression

About this trial

This is an interventional treatment trial for Unipolar Depression focused on measuring depressive episode, psychotherapy, cognitive therapy, emotional processing, RCT, exposure, dual process model, Implicit Association Test, mechanism of change

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Zurich, Department of Psychology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Cognitive-Behavioral Therapy for Depression (CBT)

Exposure-Based Cognitive Therapy for Depression (EBCT)

Arm Description

Outcomes

Primary Outcome Measures

severity of depressive symptoms measured by the Beck-Depression-Inventory (BDI-II)

Secondary Outcome Measures

symptom impairment measured by the Brief Symptom Inventory (BSI)

quality of life measured by the WHO Quality of Life-BREF (WHOQOL-BREF)

interpersonal problems measured by the Inventory of Interpersonal Problems (IIP)

avoidance measured by the Cognitive-Behavioral Avoidance Scales (CBAS)

resources measured by the Bernese Inventory of Resources (RES-K)

explicit self-esteem measured by the Rosenberg self-esteem scale (RSES)

implicit self-esteem measured by the Self-Esteem Implicit Association Test (SE-IAT)

goal attainment measured by Goal Attainment Scaling (GAS)

avoidance motivation measured by the Inventory of Approach and Avoidance Motivation (IAAM)

motivational incongruence measured by The Incongruence Questionnaire (INC)

Full Information

NCT ID

NCT01012856

First Posted

November 11, 2009

Last Updated

October 30, 2012

Sponsor

University of Zurich

1. Study Identification

Unique Protocol Identification Number

NCT01012856

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Unknown status

Study Start Date

January 2010 (undefined)

Primary Completion Date

December 2013 (Anticipated)

Study Completion Date

March 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Zurich

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Unipolar Depression

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

142 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cognitive-Behavioral Therapy for Depression (CBT)

Arm Type

Active Comparator

Arm Title

Exposure-Based Cognitive Therapy for Depression (EBCT)

Arm Type

Experimental

Intervention Type

Behavioral

Intervention Name(s)

Cognitive-Behavioral Therapy for Depression

Intervention Description

22 weekly sessions and 2 booster session of face to face outpatient psychotherapy; focus on cognitive restructuring without emotion-focused interventions

Intervention Type

Behavioral

Intervention Name(s)

Exposure-Based Cognitive Therapy for Depression

Intervention Description

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

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

symptom impairment measured by the Brief Symptom Inventory (BSI)

Time Frame

end of therapy, 6-month follow up

Title

quality of life measured by the WHO Quality of Life-BREF (WHOQOL-BREF)

Time Frame

end of therapy, 6-month follow-up

Title

interpersonal problems measured by the Inventory of Interpersonal Problems (IIP)

Time Frame

end of therapy, 6-month follow-up

Title

avoidance measured by the Cognitive-Behavioral Avoidance Scales (CBAS)

Time Frame

end of therapy, 6-month follow-up

Title

resources measured by the Bernese Inventory of Resources (RES-K)

Time Frame

end of therapy, 6-month follow-up

Title

explicit self-esteem measured by the Rosenberg self-esteem scale (RSES)

Time Frame

end of therapy, 6-month follow up

Title

implicit self-esteem measured by the Self-Esteem Implicit Association Test (SE-IAT)

Time Frame

end of therapy

Title

goal attainment measured by Goal Attainment Scaling (GAS)

Time Frame

end of therapy

Title

avoidance motivation measured by the Inventory of Approach and Avoidance Motivation (IAAM)

Time Frame

end of therpy, 6-month follow-up

Title

motivational incongruence measured by The Incongruence Questionnaire (INC)

Time Frame

end of therapy, 6-month follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Martin Grosse Holtforth, Professor MD

Organizational Affiliation

University of Zurich, Department of Psychology

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Zurich, Department of Psychology

City

Zurich

State/Province

ZIP/Postal Code

8050

Country

Switzerland

12. IPD Sharing Statement

Citations:

PubMed Identifier

17563158

Citation

Hayes AM, Feldman GC, Beevers CG, Laurenceau JP, Cardaciotto L, Lewis-Smith J. Discontinuities and cognitive changes in an exposure-based cognitive therapy for depression. J Consult Clin Psychol. 2007 Jun;75(3):409-421. doi: 10.1037/0022-006X.75.3.409.

Results Reference

background

PubMed Identifier

9874907

Citation

Hayes AM, Strauss JL. Dynamic systems theory as a paradigm for the study of change in psychotherapy: an application to cognitive therapy for depression. J Consult Clin Psychol. 1998 Dec;66(6):939-47. doi: 10.1037//0022-006x.66.6.939.

Results Reference

background

PubMed Identifier

17316941

Citation

Hayes AM, Laurenceau JP, Feldman G, Strauss JL, Cardaciotto L. Change is not always linear: the study of nonlinear and discontinuous patterns of change in psychotherapy. Clin Psychol Rev. 2007 Jul;27(6):715-23. doi: 10.1016/j.cpr.2007.01.008. Epub 2007 Jan 19.

Results Reference

background

PubMed Identifier

15905008

Citation

Beevers CG. Cognitive vulnerability to depression: a dual process model. Clin Psychol Rev. 2005 Nov;25(7):975-1002. doi: 10.1016/j.cpr.2005.03.003.

Results Reference

background

PubMed Identifier

19170458

Citation

Pascual-Leone A. Dynamic emotional processing in experiential therapy: two steps forward, one step back. J Consult Clin Psychol. 2009 Feb;77(1):113-26. doi: 10.1037/a0014488.

Results Reference

background

PubMed Identifier

29130400

Citation

Grosse Holtforth M, Krieger T, Zimmermann J, Altenstein-Yamanaka D, Dorig N, Meisch L, Hayes AM. A randomized-controlled trial of cognitive-behavioral therapy for depression with integrated techniques from emotion-focused and exposure therapies. Psychother Res. 2019 Jan;29(1):30-44. doi: 10.1080/10503307.2017.1397796. Epub 2017 Nov 12.

Results Reference

derived

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

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