This trial is active, not recruiting.

Conditions post-traumatic stress disorder (ptsd), mild traumatic brain injury (mtbi)
Treatments active acupressure treatment, placebo acupressure treatment
Sponsor VA Eastern Colorado Health Care System
Collaborator University of Colorado, Boulder
Start date June 2012
End date January 2016
Trial size 80 participants
Trial identifier NCT01614444, COMIRB# 12-0452


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
(Active Comparator)
active acupressure treatment
Participant will receive 8 active acupressure treatments.
(Placebo Comparator)
placebo acupressure treatment
Participants will receive 8 placebo acupressure treatments.

Primary Outcomes

Trier Social Stress Test
time frame: 72 hours post final acupressure treatment

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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.

Additional Information

Official title Using Complementary and Alternative Medicine (CAM) to Promote Stress Resilience in Those With Co-Occurring Mild TBI and PTSD
Principal investigator Theresa D Hernandez, Ph.D.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by VA Eastern Colorado Health Care System.