Group Intervention for Interpersonal Trauma
Primary Purpose
Post-Traumatic Stress Disorder, Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group Intervention for Interpersonal Trauma
Information only
Sponsored by
About this trial
This is an interventional treatment trial for Post-Traumatic Stress Disorder focused on measuring Major Depression, Trauma, Primary Care, Low-Income Patients
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
Sites / Locations
- Georgetown University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group therapy
Control
Arm Description
Participants will receive interpersonal group therapy.
Participants will receive information only on PTSD.
Outcomes
Primary Outcome Measures
PTSD checklist
Hamilton Depression Inventory
Secondary Outcome Measures
Inventory of Interpersonal Problems
Health care utilization
Full Information
NCT ID
NCT00348036
First Posted
June 30, 2006
Last Updated
April 29, 2013
Sponsor
Georgetown University
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00348036
Brief Title
Group Intervention for Interpersonal Trauma
Official Title
Trauma Interventions for Low-income Women in Primary Care
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Georgetown University
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Stress Disorder, Depression
Keywords
Major Depression, Trauma, Primary Care, Low-Income Patients
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group therapy
Arm Type
Experimental
Arm Description
Participants will receive interpersonal group therapy.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Participants will receive information only on PTSD.
Intervention Type
Behavioral
Intervention Name(s)
Group Intervention for Interpersonal Trauma
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Information only
Intervention Description
Participants will receive information about PTSD and depression, in the form of a brochures and a DVD about trauma and its emotional consequences.
Primary Outcome Measure Information:
Title
PTSD checklist
Time Frame
Measured at baseline, Week 12, and Month 6
Title
Hamilton Depression Inventory
Time Frame
Measured at baseline, Week 12, and Month 6
Secondary Outcome Measure Information:
Title
Inventory of Interpersonal Problems
Time Frame
Measured at baseline, Week 12, and Month 6
Title
Health care utilization
Time Frame
Measured at baseline, Week 12, and Month 6
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bonnie L. Green, PhD
Organizational Affiliation
Georgetown University Medical School Psychiatry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Georgetown University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20057
Country
United States
12. IPD Sharing Statement
Links:
URL
http://ctc.georgetown.edu
Description
Click here for the developing center website of the Georgetown Center for Trauma and the Community
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Group Intervention for Interpersonal Trauma
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