Clinical trial NCT01012856: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Unipolar Depression
Keywords: depressive episode
psychotherapy
cognitive therapy
emotional processing
RCT
exposure
dual process model
Implicit Association Test
mechanism of change
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2009-11-13
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: severity of depressive symptoms measured by the Beck-Depression-Inventory (BDI-II)
timeFrame: end of therapy, 6 month after end of therapy (follow up)
Secondary outcomes:
measure: symptom impairment measured by the Brief Symptom Inventory (BSI)
timeFrame: end of therapy, 6-month follow up
measure: quality of life measured by the WHO Quality of Life-BREF (WHOQOL-BREF)
timeFrame: end of therapy, 6-month follow-up
measure: interpersonal problems measured by the Inventory of Interpersonal Problems (IIP)
timeFrame: end of therapy, 6-month follow-up
measure: avoidance measured by the Cognitive-Behavioral Avoidance Scales (CBAS)
timeFrame: end of therapy, 6-month follow-up
measure: resources measured by the Bernese Inventory of Resources (RES-K)
timeFrame: end of therapy, 6-month follow-up
measure: explicit self-esteem measured by the Rosenberg self-esteem scale (RSES)
timeFrame: end of therapy, 6-month follow up
measure: implicit self-esteem measured by the Self-Esteem Implicit Association Test (SE-IAT)
timeFrame: end of therapy
measure: goal attainment measured by Goal Attainment Scaling (GAS)
timeFrame: end of therapy
measure: avoidance motivation measured by the Inventory of Approach and Avoidance Motivation (IAAM)
timeFrame: end of therpy, 6-month follow-up
measure: motivational incongruence measured by The Incongruence Questionnaire (INC)
timeFrame: end of therapy, 6-month follow-up
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University of Zurich, Department of Psychology
state: ZH
Study officials:
affiliation: University of Zurich, Department of Psychology
name: Martin Grosse Holtforth, Professor MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.