Treatment of Depressed Women Who Have Been Sexually Abused
| Tracking Information | |
|---|---|
| First Received Date ICMJE | July 24, 2002 |
| Last Updated Date | December 26, 2007 |
| Start Date ICMJE | September 2001 |
| Primary Completion Date | Not Provided |
| Current Primary Outcome Measures ICMJE | Not Provided |
| Original Primary Outcome Measures ICMJE | Not Provided |
| Change History | Complete list of historical versions of study NCT00042237 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | Not Provided |
| Original Secondary Outcome Measures ICMJE | Not Provided |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | Treatment of Depressed Women Who Have Been Sexually Abused |
| Official Title ICMJE | Treatment of Women With Depression and Sexual Abuse |
| 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. |
| 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 ICMJE | Interventional |
| Study Phase | Phase 1 |
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Condition ICMJE | Depression |
| Intervention ICMJE | Behavioral: Schema Therapy |
| Study Arm (s) | Not Provided |
| Publications * | Not Provided |
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 24 |
| Completion Date | Not Provided |
| Primary Completion Date | Not Provided |
| Eligibility Criteria ICMJE | Inclusion criteria:
|
| Gender | Female |
| Ages | 18 Years to 65 Years |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT Number ICMJE | NCT00042237 |
| Other Study ID Numbers ICMJE | R21 MH60216, DSIR AT-AS |
| Has Data Monitoring Committee | Not Provided |
| Responsible Party | Not Provided |
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | National Institute of Mental Health (NIMH) |
| Verification Date | December 2007 |
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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