Clinical trial NCT00348036: Group Intervention for Interpersonal Trauma
Official title: Trauma Interventions for Low-income Women in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-Traumatic Stress Disorder
Depression
Keywords: Major Depression
Trauma
Primary Care
Low-Income Patients
Lead sponsor: Georgetown University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2006-07-04
Enrollment: 27
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: PTSD checklist
timeFrame: Measured at baseline, Week 12, and Month 6
measure: Hamilton Depression Inventory
timeFrame: Measured at baseline, Week 12, and Month 6
Secondary outcomes:
measure: Inventory of Interpersonal Problems
timeFrame: Measured at baseline, Week 12, and Month 6
measure: Health care utilization
timeFrame: Measured at baseline, Week 12, and Month 6
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown University
state: District of Columbia
Study officials:
affiliation: Georgetown University Medical School Psychiatry
name: Bonnie L. Green, PhD
role: PRINCIPAL_INVESTIGATOR
References: