Group Intervention for Interpersonal Trauma

Not Applicable

Completed

• Conditions: Post-Traumatic Stress Disorder; Depression
• Interventions: Behavioral: Group Intervention for Interpersonal Trauma; Other: Information only

• Registration Number: NCT00348036
• Lead Sponsor: Georgetown University

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.

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 Timeline

• Study First Submitted: 2006-06-30
• Study First Submitted QC: 2006-06-30
• Study First Posted: 2006-07-04
• Study Start: 2008-09
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-29
• Last Update Posted: 2013-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 27

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group therapy	Group Intervention for Interpersonal Trauma	Participants will receive interpersonal group therapy.
Control	Information only	Participants will receive information only on PTSD.

Primary Outcome Measures

Name	Time	Method
Hamilton Depression Inventory	Measured at baseline, Week 12, and Month 6
PTSD checklist	Measured at baseline, Week 12, and Month 6

Secondary Outcome Measures

Name	Time	Method
Inventory of Interpersonal Problems	Measured at baseline, Week 12, and Month 6
Health care utilization	Measured at baseline, Week 12, and Month 6

Trial Locations

Locations (1)

Georgetown University; 🇺🇸 Washington, District of Columbia, United States