Group Intervention for Interpersonal Trauma

Trauma Interventions for Low-income Women in Primary Care

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.

Study Overview

• Status: Completed
• Conditions: Depression; Post-Traumatic Stress Disorder
• Intervention / Treatment: Behavioral: Group Intervention for Interpersonal Trauma; Other: Information only

Detailed Description

The aim of this study is to 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 (PTSD) following interpersonal trauma exposure. Group participants will be recruited from public sector/safety net primary care clinics. Study participants will be randomized to immediate or delayed treatment. Participants in both conditions 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. Participants will be free to attend any of the sessions they missed during the first group when the group repeats. Participants in the delayed condition will be able to attend the groups after a 12-week waiting period. Assessments of PTSD, depression, functioning, and quality of life will be conducted at three time points: baseline (prior to the start of the group), 12 weeks after the start of the group, and 6 months from the start of the group. Gift cards will be sent to the women for completing each of the assessments.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20057
      • Georgetown University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group therapy; Participants will receive interpersonal group therapy.	Behavioral: Group Intervention for Interpersonal Trauma; 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.
Active Comparator: Control; Participants will receive information only on PTSD.	Other: Information only; Participants will receive information about PTSD and depression, in the form of a brochures and a DVD about trauma and its emotional consequences.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
PTSD checklist	Measured at baseline, Week 12, and Month 6
Hamilton Depression Inventory	Measured at baseline, Week 12, and Month 6

Secondary Outcome Measures

Outcome Measure	Time Frame
Inventory of Interpersonal Problems	Measured at baseline, Week 12, and Month 6
Health care utilization	Measured at baseline, Week 12, and Month 6

Collaborators and Investigators

• Sponsor: Georgetown University
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Bonnie L. Green, PhD, Georgetown University Medical School Psychiatry

Publications and helpful links

Helpful Links

• Click here for the developing center website of the Georgetown Center for Trauma and the Community

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: June 30, 2006
• First Submitted That Met QC Criteria: June 30, 2006
• First Posted (Estimate): July 4, 2006

Study Record Updates

• Last Update Posted (Estimate): April 30, 2013
• Last Update Submitted That Met QC Criteria: April 29, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: Primary Care; Trauma; Major Depression; Low-Income Patients
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Trauma and Stressor Related Disorders; Depression; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: P20MH068450 (U.S. NIH Grant/Contract); DSIR 83-ATAS (NIMH Program Class Code)