Group Intervention for Interpersonal Trauma - Full Text View

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00348036

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	Phase
Post-Traumatic Stress Disorder Depression	Behavioral: Group Intervention for Interpersonal Trauma Other: Information only	Phase II

MedlinePlus related topics: Depression Injuries Post-Traumatic Stress Disorder Wounds

U.S. FDA Resources

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

Further study details as provided by National Institute of Mental Health (NIMH):

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 ]

Estimated Enrollment:	150
Study Start Date:	September 2008
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group therapy: Experimental 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.
Control: Active Comparator 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.

Arms

Assigned Interventions

Group therapy: Experimental

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.

Control: Active Comparator

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

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

Contacts

Contact: Janice L. Krupnick, PhD	202-687-1496	krupnicj@georgetown.edu
Contact: Bonnie L. Green, PhD	202-687-6529	bgreen01@georgetown.edu

Locations

United States, District of Columbia
Georgetown University
Washington, District of Columbia, United States, 20057

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Bonnie L. Green, PhD

Georgetown University Medical School Psychiatry

More Information

Click here for the developing center website of the Georgetown Center for Trauma and the Community This link exits the ClinicalTrials.gov site

Responsible Party:	Georgetown University Department of Psychiatry ( Bonnie L. Green, Principal Investigator )
Study ID Numbers:	P20 MH68450, DSIR 83-ATAS
Study First Received:	June 30, 2006
Last Updated:	August 18, 2008
ClinicalTrials.gov Identifier:	NCT00348036
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Major Depression
Trauma
Primary Care
Low-Income Patients

Study placed in the following topic categories:

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

ClinicalTrials.gov processed this record on January 14, 2009