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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


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
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