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Treatment of Depressed Women Who Have Been Sexually Abused

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00042237
First Posted: July 26, 2002
Last Update Posted: August 22, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by:
Butler Hospital
July 24, 2002
July 26, 2002
August 22, 2013
September 2001
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Complete list of historical versions of study NCT00042237 on ClinicalTrials.gov Archive Site
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Treatment of Depressed Women Who Have Been Sexually Abused
Treatment of Women With Depression and Sexual Abuse
The purpose of this study is to compare Schema-Focused Therapy plus antidepressant medication and antidepressant medication alone for the treatment of major depression in women with a history of childhood sexual abuse.

Schema-Focused (SF) Therapy is an extension of cognitive therapy that was developed to address the treatment needs of patients with long-standing mental disorders. SF therapy focuses on early maladaptive schemas (EMS): broad, pervasive themes regarding oneself and one's relationship with others, developed during childhood and elaborated throughout one's lifetime, which are dysfunctional to a significant degree. SF Therapy involves the identification of the particular EMS that is most relevant for each patient and attempts to modify the relevant schemas by altering the distorted views of self and others.

Participants are assessed pretreatment, after 12 weeks, posttreatment, and 3 and 6 months posttreatment. The severity of depressive symptomatology is measured and a self-report Beck Depression Inventory is administered. At the end of the study and at the follow-up intervals, participants are given the Longitudinal Interval Follow-up Evaluation, an instrument that assesses the severity of depression and dysthymia symptoms.

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Depression
Behavioral: Schema Therapy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
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Inclusion criteria:

  • Major depression
  • History of childhood sexual abuse
Sexes Eligible for Study: Female
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00042237
R21MH060216( U.S. NIH Grant/Contract )
R21MH060216 ( U.S. NIH Grant/Contract )
DSIR AT-AS
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Butler Hospital
National Institute of Mental Health (NIMH)
Not Provided
Butler Hospital
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP