Acupressure and Stress Resilience

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

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.

Study Overview

• Status: Completed
• Conditions: Post-traumatic Stress Disorder (PTSD); Mild Traumatic Brain Injury (mTBI)
• Intervention / Treatment: Other: Active Acupressure Treatment; Other: Placebo Acupressure Treatment

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80220
      • Denver VAMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Acupressure Treatment	Other: Active Acupressure Treatment; Participant will receive 8 active acupressure treatments.
Placebo Comparator: Placebo Acupressure Treatment	Other: Placebo Acupressure Treatment; Participants will receive 8 placebo acupressure treatments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Trier Social Stress Test	72 hours post final acupressure treatment

Collaborators and Investigators

• Sponsor: VA Eastern Colorado Health Care System
• Collaborators: United States Department of Defense; University of Colorado, Boulder
• Investigators: Principal Investigator: Theresa D Hernandez, Ph.D., Senior Investigator and Research Psychologist Eastern Colorado Healthcare System, VISN19, MIRECC; Principal Investigator: Lisa A Brenner, Ph.D., Eastern Colorado Healthcare System VISN 19 MIRECC Director

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2012
• Primary Completion (Actual): August 11, 2014
• Study Completion (Actual): March 7, 2017

Study Registration Dates

• First Submitted: June 5, 2012
• First Submitted That Met QC Criteria: June 5, 2012
• First Posted (Estimate): June 8, 2012

Study Record Updates

• Last Update Posted (Actual): May 19, 2017
• Last Update Submitted That Met QC Criteria: May 18, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Trauma and Stressor Related Disorders; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Brain Injuries, Traumatic; Brain Concussion
• Other Study ID Numbers: COMIRB# 12-0452