Psychotherapy for Depressed Women With Abuse Histories

Depression Clinical Trial

Official title:

Psychotherapy for Depressed Women With Abuse Histories

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00843674
• Other study ID #: NCT00257400
• Secondary ID: K23MH064528
• Status: Completed
• Phase: Phase 2
• First received: February 12, 2009
• Last updated: February 12, 2009
• Start date: September 2002
• Est. completion date: August 2007

Study information

• Verified date: February 2009
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare women randomized to Interpersonal Psychotherapy (IPT) and those randomized to usual care in a community mental health center. The main outcome is depression, and it will be assessed in several ways. Other outcome measures will provide vital information about social, psychological, and health functioning. Key patient-level variables that predict outcomes will be identified. The acceptability of IPT will also be examined.

Description:

Despite the vulnerability of sexually abused women to depression, treatments for this patient population have rarely been examined in empirically rigorous and systematic research. This study begins a program of research on interventions for depressed women with histories of childhood sexual abuse and other lifetime traumas. Interpersonal psychotherapy (IPT), a well-described and efficacious treatment that focuses on the current interpersonal difficulties of depressed patients, will be implemented and examined in this preliminary investigation of IPT for women who suffer from major depression, who have histories of childhood sexual abuse, and who are being treated in a community mental health center. This study will compare women randomized to IPT and those randomized to usual care. The main outcome is depression. Other outcome measures will provide vital information about social, psychological, and health functioning. Key patient-level variables that predict outcomes will be identified. The acceptability of IPT will also be examined.

All participants will be women who are seeking treatment in our community mental health center (Strong Behavioral Health, Adult Ambulatory Clinic). If they meet preliminary inclusion criteria during the standard adult ambulatory intake interview, they will be referred to study personnel for recruitment, informed consent, and screening. Inclusion criteria are current major depression and a history of childhood sexual abuse. Exclusion criteria include major depression with psychotic features; lifetime history of schizophrenia, bipolar disorder, or mental retardation; and active substance abuse or psychosis. Female patients (n=70) who are 18 or older, who meet criteria for major depression and childhood sexual abuse will be randomly assigned to 16-weeks of interpersonal psychotherapy (IPT) or usual care (UC). Assessments will be conducted at pretreatment, 10-weeks (mid-treatment), 24-weeks (post-treatment), and at 3-month follow up (36-weeks).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Female

• Age 18 years or older

• Clinical diagnosis of unipolar major depressive disorder

• History of childhood sexual abuse before the age of 18

• Seeking outpatient psychotherapy treatment in a community mental health center

Exclusion Criteria:

• Major depression with psychotic features

• Bipolar Disorder

• Lifetime history of schizophrenia

• Mental retardation

• Active alcohol or substance abuse within 3 months

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Behavioral:
• Interpersonal Psychotherapy

• Treatment as usual

Locations

Country	Name	City	State
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

References & Publications (2)

Talbot NL, Conwell Y, O'Hara MW, Stuart S, Ward EA, Gamble SA, Watts A, Tu X. Interpersonal psychotherapy for depressed women with sexual abuse histories: a pilot study in a community mental health center. J Nerv Ment Dis. 2005 Dec;193(12):847-50. — View Citation

Talbot NL, Gamble SA. IPT for women with trauma histories in community mental health care. Journal of Contemporary Psychotherapy 38(1): 35-44, 2008.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Rating Scale for Depression; Beck Depression Inventory-II; Structured Clinical Interview for DSM-IV Diagnoses		The primary outcome variable is depression and is measured at baseline (pretest), midtreatment (10-weeks), post-treatment (24-weeks), and follow-up (36-weeks)	Yes
Secondary	Social Adjustment Scale Medical Outcomes Survey; Symptom Checklist-90; PTSD Symptom Scale		Seconday outcome variables include social functioning, health functioning, and psychological functioning. These secondary outcomes are measured at baseline (pretest), midtreatment (10-weeks), post-treatment (24-weeks), and follow-up (36-weeks)	No