Group Intervention for Interpersonal Trauma

NCT ID: NCT00348036

Last Updated: 2013-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2010-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Post-Traumatic Stress Disorder Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group therapy

Participants will receive interpersonal group therapy.

Group Type EXPERIMENTAL

Group Intervention for Interpersonal Trauma

Intervention Type BEHAVIORAL

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

Participants will receive information only on PTSD.

Group Type ACTIVE_COMPARATOR

Information only

Intervention Type OTHER

Participants will receive information about PTSD and depression, in the form of a brochures and a DVD about trauma and its emotional consequences.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Georgetown University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bonnie L. Green, PhD

Role: PRINCIPAL_INVESTIGATOR

Georgetown University Medical School Psychiatry

Locations

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Georgetown University

Washington D.C., District of Columbia, United States

Site Status

Countries

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United States

Other Identifiers

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P20MH068450

Identifier Type: NIH

Identifier Source: secondary_id

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DSIR 83-ATAS

Identifier Type: -

Identifier Source: secondary_id

P20MH068450

Identifier Type: NIH

Identifier Source: org_study_id

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