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

Unipolar Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01012856
• Other study ID #: PP00P1_ 123377
• Status: Active, not recruiting
• Phase: Phase 2
• First received: November 11, 2009
• Last updated: October 30, 2012
• Start date: January 2010
• Est. completion date: March 2014

Study information

• Verified date: October 2012
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Federal Office of Public Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 142
• Est. completion date: March 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Unipolar Depression

Intervention

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
• Exposure-Based Cognitive Therapy for Depression
22 weekly sessions and 2 booster session of face to face outpatient psychotherapy; focus on emotion-focused interventions

Locations

Country	Name	City	State
Switzerland	University of Zurich, Department of Psychology	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

References & Publications (5)

Beevers CG. Cognitive vulnerability to depression: a dual process model. Clin Psychol Rev. 2005 Nov;25(7):975-1002. Review. — View 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):409-21. — View 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. Epub 2007 Jan 19. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	severity of depressive symptoms measured by the Beck-Depression-Inventory (BDI-II)		end of therapy, 6 month after end of therapy (follow up)	No
Secondary	symptom impairment measured by the Brief Symptom Inventory (BSI)		end of therapy, 6-month follow up	No
Secondary	quality of life measured by the WHO Quality of Life-BREF (WHOQOL-BREF)		end of therapy, 6-month follow-up	No
Secondary	interpersonal problems measured by the Inventory of Interpersonal Problems (IIP)		end of therapy, 6-month follow-up	No
Secondary	avoidance measured by the Cognitive-Behavioral Avoidance Scales (CBAS)		end of therapy, 6-month follow-up	No
Secondary	resources measured by the Bernese Inventory of Resources (RES-K)		end of therapy, 6-month follow-up	No
Secondary	explicit self-esteem measured by the Rosenberg self-esteem scale (RSES)		end of therapy, 6-month follow up	No
Secondary	implicit self-esteem measured by the Self-Esteem Implicit Association Test (SE-IAT)		end of therapy	No
Secondary	goal attainment measured by Goal Attainment Scaling (GAS)		end of therapy	No
Secondary	avoidance motivation measured by the Inventory of Approach and Avoidance Motivation (IAAM)		end of therpy, 6-month follow-up	No
Secondary	motivational incongruence measured by The Incongruence Questionnaire (INC)		end of therapy, 6-month follow-up	No