Clinical trial NCT00257400: Comparison of Two Psychotherapy Treatments for Depressed Women With a History of Sexual Abuse
Official title: Interpersonal Psychotherapy for Depressed Women With Sexual Abuse Histories
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Depression
Keywords: major depressive disorder
psychotherapy
childhood sexual abuse
trauma
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2005-11-22
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Hamilton Rating Scale for Depression
timeFrame: Measured at pre-treatment and Weeks 10, 24, and 36
measure: Beck Depression Inventory
timeFrame: Measured at pre-treatment and Weeks 10, 24, and 36
measure: Structured Clinical Interview for DSM-IV Diagnoses
timeFrame: Measured at pre-treatment and Weeks 10, 24, and 36
Secondary outcomes:
measure: Social Adjustment Scale
timeFrame: Measured at pre-treatment and Weeks 10, 24, and 36
measure: Medical Outcomes Survey
timeFrame: Measured at pre-treatment and Weeks 10, 24, and 36
measure: Post Traumatic Stress Disorder (PTSD) Symptom Scale
timeFrame: Measured at pre-treatment and Weeks 10, 24, and 36
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
affiliation: University of Rochester
name: Nancy L. Talbot, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.