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Treatment of Depressed Women Who Have Been Sexually Abused

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ClinicalTrials.gov Identifier: NCT00042237
Recruitment Status : Completed
First Posted : July 26, 2002
Last Update Posted : August 22, 2013
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by:
Butler Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Depression Behavioral: Schema Therapy Phase 1

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Women With Depression and Sexual Abuse
Study Start Date : September 2001

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Major depression
  • History of childhood sexual abuse

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00042237


Locations
United States, Rhode Island
Butler Hospital
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
Butler Hospital
National Institute of Mental Health (NIMH)

ClinicalTrials.gov Identifier: NCT00042237     History of Changes
Other Study ID Numbers: R21MH060216 ( U.S. NIH Grant/Contract )
DSIR AT-AS
First Posted: July 26, 2002    Key Record Dates
Last Update Posted: August 22, 2013
Last Verified: August 2013

Keywords provided by Butler Hospital:
Child Abuse, Sexual

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders