Acupressure and Stress Resilience
Primary Purpose
Post-traumatic Stress Disorder (PTSD), Mild Traumatic Brain Injury (mTBI)
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active Acupressure Treatment
Placebo Acupressure Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Post-traumatic Stress Disorder (PTSD)
Eligibility Criteria
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.
Sites / Locations
- Denver VAMC
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Acupressure Treatment
Placebo Acupressure Treatment
Arm Description
Outcomes
Primary Outcome Measures
Trier Social Stress Test
Secondary Outcome Measures
Full Information
NCT ID
NCT01614444
First Posted
June 5, 2012
Last Updated
May 18, 2017
Sponsor
VA Eastern Colorado Health Care System
Collaborators
University of Colorado, Boulder, United States Department of Defense
1. Study Identification
Unique Protocol Identification Number
NCT01614444
Brief Title
Acupressure and Stress Resilience
Official Title
Using Complementary and Alternative Medicine (CAM) to Promote Stress Resilience in Those With Co-Occurring Mild TBI and PTSD
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
June 13, 2012 (Actual)
Primary Completion Date
August 11, 2014 (Actual)
Study Completion Date
March 7, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VA Eastern Colorado Health Care System
Collaborators
University of Colorado, Boulder, United States Department of Defense
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-traumatic Stress Disorder (PTSD), Mild Traumatic Brain Injury (mTBI)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acupressure Treatment
Arm Type
Active Comparator
Arm Title
Placebo Acupressure Treatment
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Active Acupressure Treatment
Intervention Description
Participant will receive 8 active acupressure treatments.
Intervention Type
Other
Intervention Name(s)
Placebo Acupressure Treatment
Intervention Description
Participants will receive 8 placebo acupressure treatments.
Primary Outcome Measure Information:
Title
Trier Social Stress Test
Time Frame
72 hours post final acupressure treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theresa D Hernandez, Ph.D.
Organizational Affiliation
Senior Investigator and Research Psychologist Eastern Colorado Healthcare System, VISN19, MIRECC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lisa A Brenner, Ph.D.
Organizational Affiliation
Eastern Colorado Healthcare System VISN 19 MIRECC Director
Official's Role
Principal Investigator
Facility Information:
Facility Name
Denver VAMC
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
12. IPD Sharing Statement
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Acupressure and Stress Resilience
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