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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01614444
Other study ID # COMIRB# 12-0452
Secondary ID
Status Completed
Phase N/A
First received June 5, 2012
Last updated May 18, 2017
Start date June 13, 2012
Est. completion date March 7, 2017

Study information

Verified date May 2017
Source VA Eastern Colorado Health Care System
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date March 7, 2017
Est. primary completion date August 11, 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Active Acupressure Treatment
Participant will receive 8 active acupressure treatments.
Placebo Acupressure Treatment
Participants will receive 8 placebo acupressure treatments.

Locations

Country Name City State
United States Denver VAMC Denver Colorado

Sponsors (3)

Lead Sponsor Collaborator
VA Eastern Colorado Health Care System United States Department of Defense, University of Colorado, Boulder

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Trier Social Stress Test 72 hours post final acupressure treatment
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