Group Intervention for Interpersonal Trauma

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Georgetown University
ClinicalTrials.gov Identifier:
NCT00348036
First received: June 30, 2006
Last updated: April 29, 2013
Last verified: April 2013
  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

Resource links provided by NLM:


Further study details as provided by Georgetown University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00348036

Locations
United States, District of Columbia
Georgetown University
Washington, District of Columbia, United States, 20057
Sponsors and Collaborators
Georgetown University
Investigators
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 July 31, 2014