Trial record 8 of 151 for:    complementary and alternative medicine | Open Studies

Acupressure and Stress Resilience

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by VA Eastern Colorado Health Care System.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
University of Colorado, Boulder
Information provided by (Responsible Party):
Lisa Brenner, VA Eastern Colorado Health Care System
ClinicalTrials.gov Identifier:
NCT01614444
First received: June 5, 2012
Last updated: September 20, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Post-traumatic Stress Disorder (PTSD)
Mild Traumatic Brain Injury (mTBI)
Other: Active Acupressure Treatment
Other: Placebo Acupressure Treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Using Complementary and Alternative Medicine (CAM) to Promote Stress Resilience in Those With Co-Occurring Mild TBI and PTSD

Resource links provided by NLM:


Further study details as provided by VA Eastern Colorado Health Care System:

Primary Outcome Measures:
  • Trier Social Stress Test [ Time Frame: 72 hours post final acupressure treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: June 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Between the ages of 18-50
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01614444

Contacts
Contact: Tyler L Jorgensen, BA 303-399-8020 ext 5653 tyler.jorgensen@va.gov

Locations
United States, Colorado
Denver VAMC Recruiting
Denver, Colorado, United States, 80220
Contact: Tyler Jorgensen       tyler.jorgensen@va.gov   
Sub-Investigator: Theresa Hernandez, Ph.D.         
Sponsors and Collaborators
VA Eastern Colorado Health Care System
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
  More Information

No publications provided

Responsible Party: Lisa Brenner, Director of MIRECC (Mental Illness Research, Education and Clinical Center, VA Eastern Colorado Health Care System
ClinicalTrials.gov Identifier: NCT01614444     History of Changes
Other Study ID Numbers: COMIRB# 12-0452
Study First Received: June 5, 2012
Last Updated: September 20, 2012
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Brain Injuries
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Mental Disorders
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on October 23, 2014