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Completed

NCT Number: NCT00348036

Group Intervention for Interpersonal Trauma

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.

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Key information

Conditions

Post-traumatic Stress Disorder Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Georgetown University

Washington D.C., District of Columbia, 20057, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group Intervention for Interpersonal Trauma

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.

Information only

Other

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

Primary outcomes

  1. PTSD checklist

    Time frame: Measured at baseline, Week 12, and Month 6

  2. Hamilton Depression Inventory

    Time frame: Measured at baseline, Week 12, and Month 6

Secondary outcomes

  1. Inventory of Interpersonal Problems

    Time frame: Measured at baseline, Week 12, and Month 6

  2. Health care utilization

    Time frame: Measured at baseline, Week 12, and Month 6

Sponsors and collaborators

Lead sponsor

Georgetown University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Trauma Interventions for Low-income Women in Primary Care

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jul 4, 2006
Registry last updated
Apr 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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