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OpenTrials
Completed

NCT Number: NCT00069381

Treatment for Women With Post-Traumatic Stress Disorder Related to Childhood Abuse

This study will compare one- and two-component treatments in women with post-traumatic stress disorder (PTSD).

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Key information

Age range

22 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

NYU Child Study Center Institute for Trauma and Stress

New York, 10016, United States

About this study

PTSD is a debilitating and often chronic anxiety disorder with serious psychiatric comorbidity. The most common trauma associated with PTSD among women is childhood abuse. PTSD related to childhood abuse may cause problems with emotion regulation and interpersonal functioning. This study will address three domains of PTSD related to childhood abuse: emotion management problems, interpersonal problems, and PTSD symptoms.

Participants in this study will be randomly assigned to 16 sessions of one of three treatments: Skills Training for Affective and Interpersonal Regulation (STAIR), which focuses on helping individuals strengthen and build skills in managing feelings and improving interpersonal relationships; Modified Prolonged Exposure (MPE), which focuses on developing narratives of abuse history and completing an "emotional processing" of the trauma in a safe environment; and a combination of STAIR and MPE. Dropout rates and adverse effects will be measured.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • DSM-IV criteria for Post-Traumatic Stress Disorder related to childhood physical and/or sexual abuse by a care-giver
  • At least one clear memory of the abuse
  • Willing to have all assessments tape recorded and sessions video taped
  • Willing to maintain any concurrent treatments for the duration of the study

Exclusion criteria

  • Bipolar Disorder
  • Eating Disorder
  • Borderline Personality Disorder
  • Active substance abuse or dependence
  • Living with the abuser
  • Self mutilation
  • Pregnancy

Treatment and study plan

Psychotherapy treatment

Behavioral

Primary outcomes

  1. outcome

    Time frame: within study timeframe

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Skills Training, Exposure, and Their Combination in Childhood Abuse PTSD

Important dates

Study start
2002
Primary completion
2009
Study completion
2009
First posted
Sep 25, 2003
Registry last updated
Mar 29, 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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