Group Intervention for Interpersonal Trauma
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Post-Traumatic Stress Disorder Depression |
Behavioral: Group Intervention for Interpersonal Trauma Other: Information only |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Trauma Interventions for Low-income Women in Primary Care |
- PTSD checklist [ Time Frame: Measured at baseline, Week 12, and Month 6 ] [ Designated as safety issue: No ]
- Hamilton Depression Inventory [ Time Frame: Measured at baseline, Week 12, and Month 6 ] [ Designated as safety issue: No ]
- Inventory of Interpersonal Problems [ Time Frame: Measured at baseline, Week 12, and Month 6 ] [ Designated as safety issue: No ]
- Health care utilization [ Time Frame: Measured at baseline, Week 12, and Month 6 ] [ Designated as safety issue: No ]
| Enrollment: | 27 |
| Study Start Date: | September 2008 |
| Study Completion Date: | August 2010 |
| Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, District of Columbia | |
| Georgetown University | |
| Washington, District of Columbia, United States, 20057 | |
| Principal Investigator: | Bonnie L. Green, PhD | Georgetown University Medical School Psychiatry |
More Information
Additional Information:
No publications provided
| Responsible Party: | Georgetown University |
| ClinicalTrials.gov Identifier: | NCT00348036 History of Changes |
| Other Study ID Numbers: | P20 MH068450, P20MH068450, DSIR 83-ATAS |
| Study First Received: | June 30, 2006 |
| Last Updated: | April 29, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Georgetown University:
|
Major Depression Trauma Primary Care Low-Income Patients |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Stress Disorders, Post-Traumatic Stress Disorders, Traumatic |
Behavioral Symptoms Mood Disorders Mental Disorders Anxiety Disorders |
ClinicalTrials.gov processed this record on May 19, 2013