Treatment of Depressed Women Who Have Been Sexually Abused

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Butler Hospital
ClinicalTrials.gov Identifier:
NCT00042237
First received: July 24, 2002
Last updated: August 20, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Depression
Behavioral: Schema Therapy
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Women With Depression and Sexual Abuse

Resource links provided by NLM:


Further study details as provided by Butler Hospital:

Estimated Enrollment: 24
Study Start Date: September 2001
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Major depression
  • History of childhood sexual abuse
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00042237

Locations
United States, Rhode Island
Butler Hospital
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
Butler Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00042237     History of Changes
Other Study ID Numbers: R21 MH60216, R21MH060216, DSIR AT-AS
Study First Received: July 24, 2002
Last Updated: August 20, 2013
Health Authority: United States: Federal Government

Keywords provided by Butler Hospital:
Child Abuse, Sexual

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

ClinicalTrials.gov processed this record on April 23, 2014