Post-traumatic Stress Disorder (PTSD)NCT01614444
Acupressure and Stress Resilience
A study testing Active Acupressure Treatment in people with Post-traumatic Stress Disorder (PTSD) and Mild Traumatic Brain Injury (mTBI), run by VA Eastern Colorado Health Care System at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Post-traumatic Stress Disorder (PTSD), Mild Traumatic Brain Injury (mTBI)
- What is being tested?
- Active Acupressure Treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2012to 7 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Active Acupressure Treatment, Placebo Acupressure Treatment
- Medical subject headings
- Stress Disorders, Post-Traumatic, Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Acupressure TreatmentOther
Participant will receive 8 active acupressure treatments.
Placebo Acupressure TreatmentOther
Participants will receive 8 placebo acupressure treatments.
| Study group | Role | What they receive |
|---|---|---|
| Acupressure Treatment | Active comparator | Not described Receives: Other: Active Acupressure Treatment |
| Placebo Acupressure Treatment | Placebo comparator | Not described Receives: Other: Placebo Acupressure Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trier Social Stress Test
Measured: 72 hours post final acupressure treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2012 (estimated)
- Study start13 Jun 2012
- Primary completion11 Aug 2014
- Study completion7 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-traumatic Stress Disorder (PTSD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Eastern Colorado Health Care System
- Sponsor type
- US federal agency
- Collaborators
- University of Colorado, Boulder, United States Department of Defense
- Responsible party
- Principal investigator, Lisa Brenner, VA Eastern Colorado Health Care System
- Investigators
- Theresa D Hernandez, Ph.D., Principal investigator, Senior Investigator and Research Psychologist Eastern Colorado Healthcare System, VISN19, MIRECCLisa A Brenner, Ph.D., Principal investigator, Eastern Colorado Healthcare System VISN 19 MIRECC Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01614444
- Sponsor's protocol ID
- COMIRB# 12-0452
- Status last verified
- May 2017
- First submitted
- 5 Jun 2012
- Last updated
- 19 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Complementary and Alternative Medicine (CAM) to Promote Stress Resilience in Those With Co-Occurring Mild TBI and PTSD
- ClinicalTrials.gov ID
- NCT01614444
- Acronym / sponsor ID
- COMIRB# 12-0452
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- VA Eastern Colorado Health Care SystemUS federal agency
- Collaborators
- University of Colorado, Boulder, United States Department of Defense
- Study start
- 13 Jun 2012 (actual)
- Primary completion
- 11 Aug 2014 (actual)
- Study completion
- 7 Mar 2017 (actual)
- First posted
- 8 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupressure Treatment | Active comparator | Other: Active Acupressure Treatment |
| Placebo Acupressure Treatment | Placebo comparator | Other: Placebo Acupressure Treatment |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Acupressure TreatmentParticipant will receive 8 active acupressure treatments. | Other | Acupressure Treatment |
| Placebo Acupressure TreatmentParticipants will receive 8 placebo acupressure treatments. | Other | Placebo Acupressure Treatment |
Primary outcome
Trier Social Stress Test
Time frame: 72 hours post final acupressure treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theresa D Hernandez, Ph.D. principal investigator
Senior Investigator and Research Psychologist Eastern Colorado Healthcare System, VISN19, MIRECC
Lisa A Brenner, Ph.D. principal investigator
Eastern Colorado Healthcare System VISN 19 MIRECC Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Acupressure Treatment in people with Post-traumatic Stress Disorder (PTSD) and Mild Traumatic Brain Injury (mTBI), run by VA Eastern Colorado Health Care System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trier Social Stress Test (time frame: 72 hours post final acupressure treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2017.