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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00348036 |
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 | Phase |
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Post-Traumatic Stress Disorder Depression |
Behavioral: Group Intervention for Interpersonal Trauma Other: Information only |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Trauma Interventions for Low-Income Women in Primary Care |
Estimated Enrollment: | 150 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group therapy: Experimental
Participants will receive interpersonal group therapy.
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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. |
Control: Active Comparator
Participants will receive information only on PTSD.
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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.
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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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Janice L. Krupnick, PhD | 202-687-1496 | krupnicj@georgetown.edu |
Contact: Bonnie L. Green, PhD | 202-687-6529 | bgreen01@georgetown.edu |
United States, District of Columbia | |
Georgetown University | Recruiting |
Washington, District of Columbia, United States, 20057 |
Principal Investigator: | Bonnie L. Green, PhD | Georgetown University Medical School Psychiatry |
Responsible Party: | Georgetown University Department of Psychiatry ( Bonnie L. Green, Principal Investigator ) |
Study ID Numbers: | P20 MH068450, DSIR 83-ATAS |
Study First Received: | June 30, 2006 |
Last Updated: | March 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00348036 History of Changes |
Health Authority: | United States: Federal Government |
Major Depression Trauma Primary Care Low-Income Patients |
Depression Anxiety Disorders Mental Disorders Mood Disorders Wounds and Injuries Stress Disorders, Post-Traumatic |
Stress Depressive Disorder, Major Depressive Disorder Stress Disorders, Traumatic Behavioral Symptoms |
Depression Anxiety Disorders Mental Disorders Mood Disorders |
Stress Disorders, Post-Traumatic Depressive Disorder Stress Disorders, Traumatic Behavioral Symptoms |