NCT00257400

Brief Summary

This study will compare the effectiveness of individual versus interpersonal psychotherapy in treating depressed women with a history of sexual abuse.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for phase_1 depression

Timeline
Completed

Started May 2003

Longer than P75 for phase_1 depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2003

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

November 21, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 22, 2005

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

January 3, 2014

Status Verified

December 1, 2013

Enrollment Period

4.3 years

First QC Date

November 21, 2005

Last Update Submit

December 31, 2013

Conditions

Keywords

major depressive disorderpsychotherapychildhood sexual abusetrauma

Outcome Measures

Primary Outcomes (3)

  • Hamilton Rating Scale for Depression

    Measured at pre-treatment and Weeks 10, 24, and 36

  • Beck Depression Inventory

    Measured at pre-treatment and Weeks 10, 24, and 36

  • Structured Clinical Interview for DSM-IV Diagnoses

    Measured at pre-treatment and Weeks 10, 24, and 36

Secondary Outcomes (3)

  • Social Adjustment Scale

    Measured at pre-treatment and Weeks 10, 24, and 36

  • Medical Outcomes Survey

    Measured at pre-treatment and Weeks 10, 24, and 36

  • Post Traumatic Stress Disorder (PTSD) Symptom Scale

    Measured at pre-treatment and Weeks 10, 24, and 36

Study Arms (2)

Interpersonal Psychotherapy (IPT)

EXPERIMENTAL

Interpersonal Psychotherapy

Behavioral: Interpersonal Psychotherapy (IPT)

Individual Psychotherapy

ACTIVE COMPARATOR

Individual Psychotherapy

Behavioral: Individual Psychotherapy

Interventions

Interpersonal Psychotherapy

Interpersonal Psychotherapy (IPT)

Individual Psychotherapy

Individual Psychotherapy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meets DSM-IV criteria for unipolar major depressive disorder
  • History of childhood sexual abuse before the age of 18
  • Seeking outpatient psychotherapy treatment in a community mental health center

You may not qualify if:

  • Meets DSM-IV criteria for major depression with psychotic features, bipolar disorder, schizophrenia, or mental retardation
  • Active alcohol or substance abuse within 3 months of study entry date

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Related Publications (7)

  • 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. doi: 10.1097/01.nmd.0000188987.07734.22.

  • Talbot NL, Chaudron LH, Ward EA, Duberstein PR, Conwell Y, O'Hara MW, Tu X, Lu N, He H, Stuart S. A randomized effectiveness trial of interpersonal psychotherapy for depressed women with sexual abuse histories. Psychiatr Serv. 2011 Apr;62(4):374-80. doi: 10.1176/ps.62.4.pss6204_0374.

  • Smith PN, Gamble SA, Cort NA, Ward EA, He H, Talbot NL. Attachment and alliance in the treatment of depressed, sexually abused women. Depress Anxiety. 2012 Feb;29(2):123-30. doi: 10.1002/da.20913. Epub 2011 Nov 7.

  • Smith PN, Gamble SA, Cort NA, Ward EA, Conwell Y, Talbot NL. The relationships of attachment style and social maladjustment to death ideation in depressed women with a history of childhood sexual abuse. J Clin Psychol. 2012 Jan;68(1):78-87. doi: 10.1002/jclp.20852. Epub 2011 Nov 28.

  • Cankaya B, Talbot NL, Ward EA, Duberstein PR. Parental sexual abuse and suicidal behaviour among women with major depressive disorder. Can J Psychiatry. 2012 Jan;57(1):45-51. doi: 10.1177/070674371205700108.

  • You S, Talbot NL, He H, Conner KR. Emotions and suicidal ideation among depressed women with childhood sexual abuse histories. Suicide Life Threat Behav. 2012 Jun;42(3):244-54. doi: 10.1111/j.1943-278X.2012.00086.x. Epub 2012 Mar 12.

  • Cort NA, Gamble SA, Smith PN, Chaudron LH, Lu N, He H, Talbot NL. Predictors of treatment outcomes among depressed women with childhood sexual abuse histories. Depress Anxiety. 2012 Jun;29(6):479-86. doi: 10.1002/da.21942. Epub 2012 May 8.

MeSH Terms

Conditions

DepressionDepressive Disorder, MajorWounds and Injuries

Interventions

Interpersonal Psychotherapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorDepressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Nancy L. Talbot, PhD

    University of Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 21, 2005

First Posted

November 22, 2005

Study Start

May 1, 2003

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

January 3, 2014

Record last verified: 2013-12

Locations