Comparison of Two Psychotherapy Treatments for Depressed Women With a History of Sexual Abuse

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT00257400
First received: November 21, 2005
Last updated: December 31, 2013
Last verified: December 2013

November 21, 2005
December 31, 2013
May 2003
August 2007   (final data collection date for primary outcome measure)
  • Hamilton Rating Scale for Depression [ Time Frame: Measured at pre-treatment and Weeks 10, 24, and 36 ]
  • Beck Depression Inventory [ Time Frame: Measured at pre-treatment and Weeks 10, 24, and 36 ]
  • Structured Clinical Interview for DSM-IV Diagnoses [ Time Frame: Measured at pre-treatment and Weeks 10, 24, and 36 ]
  • Hamilton Rating Scale for Depression
  • Beck Depression Inventory
  • 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):
  • Depression will be rated by several scales:
Complete list of historical versions of study NCT00257400 on ClinicalTrials.gov Archive Site
  • Social Adjustment Scale [ Time Frame: Measured at pre-treatment and Weeks 10, 24, and 36 ]
  • Medical Outcomes Survey [ Time Frame: Measured at pre-treatment and Weeks 10, 24, and 36 ]
  • Post Traumatic Stress Disorder (PTSD) Symptom Scale [ Time Frame: Measured at pre-treatment and Weeks 10, 24, and 36 ]
  • 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):
  • Social Adjustment Scale
  • Medical Outcomes Survey
  • Symptom Checklist-90
  • PTSD Symptom Scale
Not Provided
Not Provided
 
Comparison of Two Psychotherapy Treatments for Depressed Women With a History of Sexual Abuse
Interpersonal Psychotherapy for Depressed Women With Sexual Abuse Histories

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

Depression is a common but serious mental disorder that affects millions of people each year. Depression can severely impact people's lives, causing them to often feel sad and hopeless, as well as affecting people's sleep patterns, concentration, and energy levels. Women with a history of abuse are at an increased risk for developing symptoms of depression. However, treatments such as interpersonal psychotherapy and individual psychotherapy have been known to reduce symptoms of depression. This study will compare the effectiveness of individual and interpersonal psychotherapy in improving depressive symptoms and daily functioning in depressed women with a history of sexual abuse.

Participants in this study will undergo a two-part screening interview at the Strong Adult Ambulatory Clinic. This screening will include both written questionnaires and face-to-face interviews regarding any experiences of sexual or physical abuse; suicidal thoughts; family relationships; and current attitudes, thoughts, or feelings. Participants who meet all criteria will then be randomly assigned to receive one of two treatments: interpersonal psychotherapy or individual psychotherapy, which is considered usual care. All treatment sessions will be held at the Strong Adult Ambulatory Clinic. Participants assigned to receive interpersonal psychotherapy will attend weekly 50-minute sessions with a therapist. Interpersonal psychotherapy will focus on current interpersonal stressors in daily life, such as difficulties in close relationships or at work. Treatment will also help participants examine the relationship between their mood changes and interpersonal problems. Participants assigned to receive individual psychotherapy will undergo cognitive-behavioral therapy, supportive counseling, or a combination of the two. Participants will work with their therapists to decide upon a treatment plan designed to help changes in mood and other difficulties in daily life. The number and length of treatment sessions for this group will be determined on an individual basis. For all participants, evaluations consisting of questionnaires similar to those from the initial screening will be completed at mid-treatment, post-treatment, and 3 months after treatment.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Depression
  • Behavioral: Interpersonal Psychotherapy (IPT)
    Interpersonal Psychotherapy
  • Behavioral: Individual Psychotherapy
    Individual Psychotherapy
  • Experimental: Interpersonal Psychotherapy (IPT)
    Interpersonal Psychotherapy
    Intervention: Behavioral: Interpersonal Psychotherapy (IPT)
  • Active Comparator: Individual Psychotherapy
    Individual Psychotherapy
    Intervention: Behavioral: Individual Psychotherapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
August 2007
August 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00257400
K23 MH064528, K23MH064528, DSIR 8K-RTAT
No
Not Provided
University of Rochester
National Institute of Mental Health (NIMH)
Principal Investigator: Nancy L. Talbot, PhD University of Rochester
University of Rochester
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP