Acupressure and Stress Resilience

Post-traumatic Stress Disorder (PTSD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01614444
• Other study ID #: COMIRB# 12-0452
• 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
• 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.

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Mild Traumatic Brain Injury (mTBI)
• Post-traumatic Stress Disorder (PTSD)
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

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