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

June 30, 2006
April 29, 2013
September 2008
August 2010   (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
Not Provided
Not Provided
 
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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Post-Traumatic Stress Disorder
  • Depression
  • 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.
  • 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.
  • Experimental: Group therapy
    Participants will receive interpersonal group therapy.
    Intervention: Behavioral: Group Intervention for Interpersonal Trauma
  • Active Comparator: Control
    Participants will receive information only on PTSD.
    Intervention: Other: Information only
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
August 2010
August 2010   (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
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00348036
P20 MH068450, P20MH068450, DSIR 83-ATAS
No
Georgetown University
Georgetown University
National Institute of Mental Health (NIMH)
Principal Investigator: Bonnie L. Green, PhD Georgetown University Medical School Psychiatry
Georgetown University
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP