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

NCT ID: NCT01012856

Last Updated: 2012-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2014-03-31

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.

Detailed Description

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Conditions

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Unipolar Depression

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Cognitive-Behavioral Therapy for Depression (CBT)

Group Type ACTIVE_COMPARATOR

Cognitive-Behavioral Therapy for Depression

Intervention Type BEHAVIORAL

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

Exposure-Based Cognitive Therapy for Depression (EBCT)

Group Type EXPERIMENTAL

Exposure-Based Cognitive Therapy for Depression

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type BEHAVIORAL

Exposure-Based Cognitive Therapy for Depression

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

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Martin Grosse Holtforth, Professor MD

Role: PRINCIPAL_INVESTIGATOR

University of Zurich, Department of Psychology

Locations

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University of Zurich, Department of Psychology

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type BACKGROUND
PMID: 17563158 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9874907 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17316941 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15905008 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19170458 (View on PubMed)

Babl A, Rubel J, Gomez Penedo JM, Berger T, Grosse Holtforth M, Eubanks CF. Can session-by-session changes in self-reported alliance scores serve as a measure of ruptures in the therapeutic alliance? J Consult Clin Psychol. 2024 Feb;92(2):129-133. doi: 10.1037/ccp0000861. Epub 2023 Nov 27.

Reference Type DERIVED
PMID: 38010758 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29130400 (View on PubMed)

Other Identifiers

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PP00P1_ 123377

Identifier Type: -

Identifier Source: org_study_id