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Clinical Trials/NCT01614444
NCT01614444
Completed
Not Applicable

Using Complementary and Alternative Medicine (CAM) to Promote Stress Resilience in Those With Co-Occurring Mild TBI and PTSD

VA Eastern Colorado Health Care System1 site in 1 country60 target enrollmentJune 13, 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Post-traumatic Stress Disorder (PTSD)
Sponsor
VA Eastern Colorado Health Care System
Enrollment
60
Locations
1
Primary Endpoint
Trier Social Stress Test
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

The current study will assess the efficacy of acupressure, a type of complementary and alternative medicine (CAM) in the Veteran population. Veterans with co-occurring mild traumatic brain injury (mTBI) and post-traumatic stress disorder (PTSD) will be consented and randomly assigned to either an active or placebo acupressure treatment series of 8 sessions. The investigators will determine if acupressure affects aspects of day-to-day function, such as memory, sleep, mood, psychiatric health and stress resilience. This information will help identify potential treatment strategies to improve quality of life and overall function in this particular Veteran population.

Registry
clinicaltrials.gov
Start Date
June 13, 2012
End Date
March 7, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lisa Brenner

Director of MIRECC (Mental Illness Research, Education and Clinical Center

VA Eastern Colorado Health Care System

Eligibility Criteria

Inclusion Criteria

  • Between the ages of 18-60
  • Diagnosis of mild TBI and PTSD as assessed by interview and/or chart review
  • Currently receiving or eligible to receive physical and/or mental healthcare through the VA Eastern Colorado Health Care System

Exclusion Criteria

  • History of other significant neurological disease (e.g., Alzheimer's, Parkinson's, multiple sclerosis etc.) as assessed by interview and/or chart review. Such conditions could affect outcome measures independently, thereby creating an experimental confound.
  • History or diagnosis of lifetime moderate to severe TBI, as assessed by interview and/or chart review.
  • History of psychotic disorder or bipolar I disorder as assessed by structured interview. Such conditions could affect outcome measures independently, thereby creating an experimental confound.
  • Inability to read the informed consent document or adequately respond to questions regarding the informed consent procedure.
  • Prior experience with acupressure, as this would result in individuals potentially being able to detect Placebo treatments if randomly assigned to that group.

Outcomes

Primary Outcomes

Trier Social Stress Test

Time Frame: 72 hours post final acupressure treatment

Study Sites (1)

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