Group Intervention for Interpersonal Trauma

Depression Clinical Trial

Official title:

Trauma Interventions for Low-income Women in Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00348036
• Other study ID #: P20MH068450
• Secondary ID: P20MH068450DSIR
• Status: Completed
• Phase: N/A
• First received: June 30, 2006
• Last updated: April 29, 2013
• Start date: September 2008
• Est. completion date: August 2010

Study information

• Verified date: April 2013
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Post-Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.

Locations

Country	Name	City	State
United States	Georgetown University	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Georgetown University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PTSD checklist		Measured at baseline, Week 12, and Month 6	No
Primary	Hamilton Depression Inventory		Measured at baseline, Week 12, and Month 6	No
Secondary	Inventory of Interpersonal Problems		Measured at baseline, Week 12, and Month 6	No
Secondary	Health care utilization		Measured at baseline, Week 12, and Month 6	No

External Links

•   Click here for the developing center website of the Georgetown Center for Trauma and the Community