Group Intervention for Interpersonal Trauma

Study Overview
=================
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.

Official Title
-----------------
Trauma Interventions for Low-income Women in Primary Care

Conditions
-----------------
Post-Traumatic Stress Disorder, Depression

Intervention / Treatment
-----------------
* Behavioral: Group Intervention for Interpersonal Trauma
* Other: Information only


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Major Depression, Trauma, Primary Care, Low-Income Patients