NCT01012856

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
142

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2010

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 11, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 13, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

October 31, 2012

Status Verified

October 1, 2012

Enrollment Period

3.9 years

First QC Date

November 11, 2009

Last Update Submit

October 30, 2012

Conditions

Unipolar Depression

Keywords

depressive episodepsychotherapycognitive therapyemotional processingRCTexposuredual process modelImplicit Association Testmechanism of change

Outcome Measures

Primary Outcomes (1)

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

    end of therapy, 6 month after end of therapy (follow up)

Secondary Outcomes (10)

  • 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

  • +5 more secondary outcomes

Study Arms (2)

Cognitive-Behavioral Therapy for Depression (CBT)

ACTIVE COMPARATOR
Behavioral: Cognitive-Behavioral Therapy for Depression

Exposure-Based Cognitive Therapy for Depression (EBCT)

EXPERIMENTAL
Behavioral: Exposure-Based Cognitive Therapy for Depression

Interventions

Cognitive-Behavioral Therapy for DepressionBEHAVIORAL

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

Cognitive-Behavioral Therapy for Depression (CBT)
Exposure-Based Cognitive Therapy for DepressionBEHAVIORAL

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

Exposure-Based Cognitive Therapy for Depression (EBCT)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Zurich, Department of Psychology

Zurich, Canton of Zurich, 8050, Switzerland

Location

Related Publications (7)

  • 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.

    PMID: 17563158BACKGROUND

  • 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.

    PMID: 9874907BACKGROUND

  • 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.

    PMID: 17316941BACKGROUND

  • 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.

    PMID: 15905008BACKGROUND

  • 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.

    PMID: 19170458BACKGROUND

  • 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.

    PMID: 38010758DERIVED

  • 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.

    PMID: 29130400DERIVED

MeSH Terms

Conditions

Depressive Disorder

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Mood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Martin Grosse Holtforth, Professor MD

    University of Zurich, Department of Psychology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2009

First Posted

November 13, 2009

Study Start

January 1, 2010

Primary Completion

December 1, 2013

Study Completion

March 1, 2014

Last Updated

October 31, 2012

Record last verified: 2012-10

Locations

CH(1)