Acupressure and Stress Resilience

NCT ID: NCT01614444

Last Updated: 2017-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-13

Study Completion Date

2017-03-07

Brief Summary

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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.

Detailed Description

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Conditions

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Post-traumatic Stress Disorder (PTSD) Mild Traumatic Brain Injury (mTBI)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Acupressure Treatment

Group Type ACTIVE_COMPARATOR

Active Acupressure Treatment

Intervention Type OTHER

Participant will receive 8 active acupressure treatments.

Placebo Acupressure Treatment

Group Type PLACEBO_COMPARATOR

Placebo Acupressure Treatment

Intervention Type OTHER

Participants will receive 8 placebo acupressure treatments.

Interventions

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Active Acupressure Treatment

Participant will receive 8 active acupressure treatments.

Intervention Type OTHER

Placebo Acupressure Treatment

Participants will receive 8 placebo acupressure treatments.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Colorado, Boulder

OTHER

Sponsor Role collaborator

United States Department of Defense

FED

Sponsor Role collaborator

VA Eastern Colorado Health Care System

FED

Sponsor Role lead

Responsible Party

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Lisa Brenner

Director of MIRECC (Mental Illness Research, Education and Clinical Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Theresa D Hernandez, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Senior Investigator and Research Psychologist Eastern Colorado Healthcare System, VISN19, MIRECC

Lisa A Brenner, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Eastern Colorado Healthcare System VISN 19 MIRECC Director

Locations

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Denver VAMC

Denver, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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COMIRB# 12-0452

Identifier Type: -

Identifier Source: org_study_id

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