| June 30, 2006 |
| March 27, 2009 |
| September 2008 |
| October 2009 (final data collection date for primary outcome measure) |
- 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 ]
|
- Measured at Months 4 and 8: PTSD checklist
- Hamilton Depression Inventory
|
| Complete list of historical versions of study NCT00348036 on ClinicalTrials.gov Archive Site |
- 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 ]
|
- Measured at Months 4 and 8: Inventory of Interpersonal Problems
- Health care utilization
|
| |
| 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. |
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. |
| Phase II |
| Interventional |
| Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
- Post-Traumatic Stress Disorder
- Depression
|
- Behavioral: Group Intervention for Interpersonal Trauma
- Other: Information only
|
- Experimental: Participants will receive interpersonal group therapy.
- Active Comparator: Participants will receive information only on PTSD.
|
| |
| |
| Recruiting |
| 150 |
| October 2009 |
| October 2009 (final data collection date for primary outcome measure) |
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
|
| Female |
| 18 Years to 70 Years |
| No |
|
|
| United States |
| |
| NCT00348036 |
| Bonnie L. Green, Principal Investigator, Georgetown University Department of Psychiatry |
| P20 MH068450, DSIR 83-ATAS |
| National Institute of Mental Health (NIMH) |
|
| Principal Investigator: |
Bonnie L. Green, PhD |
Georgetown University Medical School Psychiatry |
|
|
| National Institute of Mental Health (NIMH) |
| March 2009 |