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

• Sponsor: University of Zurich (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01012856
• Collaborator: (none)
• Enrollment: 142
• Location: 1
• Arms: 2
• Duration (Months): 49.9
• Patients Per Site Per Month: 2.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Unipolar Depression	Behavioral: Cognitive-Behavioral Therapy for Depression; Behavioral: Exposure-Based Cognitive Therapy for Depression	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 142 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Explicit and Implicit Change of Depression in Exposure-based Cognitive Therapy
• Study Start Date: Jan 1, 2010
• Anticipated Primary Completion Date: Dec 1, 2013
• Anticipated Study Completion Date: Mar 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Cognitive-Behavioral Therapy for Depression (CBT)	Behavioral: 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
Experimental: Exposure-Based Cognitive Therapy for Depression (EBCT)	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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

1. symptom impairment measured by the Brief Symptom Inventory (BSI) [end of therapy, 6-month follow up]

2. quality of life measured by the WHO Quality of Life-BREF (WHOQOL-BREF) [end of therapy, 6-month follow-up]

3. interpersonal problems measured by the Inventory of Interpersonal Problems (IIP) [end of therapy, 6-month follow-up]

4. avoidance measured by the Cognitive-Behavioral Avoidance Scales (CBAS) [end of therapy, 6-month follow-up]

5. resources measured by the Bernese Inventory of Resources (RES-K) [end of therapy, 6-month follow-up]

6. explicit self-esteem measured by the Rosenberg self-esteem scale (RSES) [end of therapy, 6-month follow up]

7. implicit self-esteem measured by the Self-Esteem Implicit Association Test (SE-IAT) [end of therapy]

8. goal attainment measured by Goal Attainment Scaling (GAS) [end of therapy]

9. avoidance motivation measured by the Inventory of Approach and Avoidance Motivation (IAAM) [end of therpy, 6-month follow-up]

10. motivational incongruence measured by The Incongruence Questionnaire (INC) [end of therapy, 6-month follow-up]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Zurich, Department of Psychology	Zurich	ZH	Switzerland	8050

Sponsors and Collaborators

• University of Zurich

Investigators

• Principal Investigator: Martin Grosse Holtforth, Professor MD, University of Zurich, Department of Psychology

Study Documents (Full-Text)

None provided.

More Information

Publications

• Beevers CG. Cognitive vulnerability to depression: a dual process model. Clin Psychol Rev. 2005 Nov;25(7):975-1002. Review.
• 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.
• 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. Epub 2007 Jan 19. Review.
• 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.
• 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.

• Responsible Party: University of Zurich
• ClinicalTrials.gov Identifier: NCT01012856
• Other Study ID Numbers: PP00P1_ 123377
• First Posted: Nov 13, 2009
• Last Update Posted: Oct 31, 2012
• Last Verified: Oct 1, 2012

• Keywords provided by University of Zurich: depressive episode; psychotherapy; cognitive therapy; emotional processing; RCT; exposure; dual process model; Implicit Association Test; mechanism of change
• Additional relevant MeSH terms: Depression; Depressive Disorder

Study Results

No Results Posted as of Oct 31, 2012