Group Intervention for Interpersonal Trauma

NCT00348036 | Completed

• 2 other identifiers: P20MH068450DSIR 83-ATAS
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

This study will assess the acceptability and effectiveness of a six-session, modular, repeating group for low-income women who have symptoms of depression and/or post-traumatic stress disorder following interpersonal trauma exposure.

Conditions

Post-Traumatic Stress Disorder; Depression

Keywords

Major Depression; Trauma; Primary Care; Low-Income Patients

Outcome Measures

Primary Outcomes (2)

• PTSD checklist

  Measured at baseline, Week 12, and Month 6

• Hamilton Depression Inventory

  Measured at baseline, Week 12, and Month 6

Secondary Outcomes (2)

• Inventory of Interpersonal Problems

  Measured at baseline, Week 12, and Month 6

• Health care utilization

  Measured at baseline, Week 12, and Month 6

Study Arms (2)

Group therapy

EXPERIMENTAL

Participants will receive interpersonal group therapy.

Behavioral: Group Intervention for Interpersonal Trauma

Control

ACTIVE COMPARATOR

Participants will receive information only on PTSD.

Other: Information only

Interventions

Group Intervention for Interpersonal Trauma BEHAVIORAL

Participants will receive information about PTSD and depression, in the form of a brochures and a DVD about trauma and its emotional consequences. Groups will be comprised of three components at each meeting: psycho-education, current relationship issues, and coping skills. Each group session will focus on a different aspect of education. Next, relationship difficulties typically associated with the symptoms discussed in that module will be addressed, and there will be group discussion about participants' relationship difficulties. Each group will end with the therapist teaching a coping skill that fits with the issues discussed earlier.

Group therapy

Information only OTHER

Participants will receive information about PTSD and depression, in the form of a brochures and a DVD about trauma and its emotional consequences.

Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Exposure to an interpersonal traumatic event
• Diagnosis of depression or PTSD (threshold or subthreshold)
• Functional literacy

You may not qualify if:

• Apparent incoherence or disorientation
• Apparent intoxication at recruitment
• Hearing impairment

Sponsors & Collaborators

• Georgetown University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Georgetown University

Washington D.C., District of Columbia, 20057, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depression; Depressive Disorder, Major; Wounds and Injuries

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders

Study Officials

• Bonnie L. Green, PhD

  Georgetown University Medical School Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2006
• First Posted: July 4, 2006
• Study Start: September 1, 2008
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: April 30, 2013

Record last verified: 2013-04

Locations

US (1)