Posttraumatic Stress DisorderRRNCT01725854
Relaxation Response Training for PTSD Prevention in US Military Personnel
A study testing Relaxation Response training in people with Posttraumatic Stress Disorder, run by William Beaumont Army Medical Center at 1 site in United States.
Trial summary
The purposes of this study are to evaluate the acceptability and utility of a mind-body intervention on a convenience sample of Soldiers (n=120) who have screened positive through RESPECT-MIL for symptoms that may lead to post-traumatic stress and to test the effectiveness of this Relaxation Response (RR) intervention… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Relaxation Response training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to May 2015
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older, male and female volunteer individual military Service Members, DoD civilians or approved contractors working for DoD, primarily from multidisciplinary healthcare providers.
- Willingness to participate in the research project.
- Committed to the entire period of time of the research project.
- Currently working or stationed at Ft Bliss, Texas.
- No impending orders for deployment/ TDY/ PCS/ ETS or retirement for at least 8 weeks from the day of study enrollment.
- Able to read and speak English.
- Capable to consent.
Who cannot join
- Diagnosed with severe PTSD or other mental health issues disclosed as self-reported
Trial locations and contacts
1 site in 1 country.
United States1 site
William Beaumont Army Medical Center, Ft Bliss
El Paso, Texas, 79920
About this study
Official title: Relaxation Response (RR) Training for PTSD Prevention in Soldiers a.k.a. "SPIRIT SMART" (Stemming PTSD, Increasing Resilience and Impeding Trauma in Service Members: Assessing Relaxation Response Training)
The purposes of this study are to evaluate the acceptability and utility of a mind-body intervention on a convenience sample of Soldiers (n=120) who have screened positive through RESPECT-MIL for symptoms that may lead to post-traumatic stress and to test the effectiveness of this Relaxation Response (RR) intervention designed to decrease the physiological and psychosocial effects of stress and trauma. The study aims to enhance the psychological health of Soldiers with a RR intervention designed to promote self-awareness of physiological responses to stress and the ability to increase relaxation responses.
Read the detailed description
Specific Aims:
- Demonstrate that trainers can be trained effectively to deliver the intervention, a mind-body skills training program based on the Benson-Henry Institute's standard RR training curriculum and tailored to a military population.
- Evaluate feasibility, acceptability, and compliance to the training program in an active duty military population.
- Compare outcomes on sleep disturbance, PTSD, stress-related symptoms, quality of life, and psychosocial variables related to resilience of Soldiers who receive the 6-week training program to promote the Relaxation Response to those Soldiers who do not receive the intervention.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Relaxation Response training
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relaxation Response trainingBehavioural
Also called Benson-Henry Institute Relaxation response training
Behavioral Relaxation Response Training (Benson-Henry Institute Relaxation Response Training) Participants randomized to the intervention group will participate in the six weekly RR sessions. Examples of in-group skill building exercises are mini relaxations, diaphragmatic breathing, introduction to imagery, and eliciting RR through Yoga. Presentations topics include Introduction to Mind/Body Medicine, Introduction to the RR, Experiential RR Sessions, and Introduction to Cognitive Restructuring. Home skill building assignments include relaxation focus practice, an appreciation journal, self-monitoring with Biodots (biosensor technology that helps participants to monitor and regulate their psycho-emotional state), physical activity, balanced nutrition, and progress notes.
| Study group | Role | What they receive |
|---|---|---|
| Relaxation Response Training | Experimental | The Military tailored RR training program will consist of six weekly small group sessions which involve group presentations, in-group skill building exercises, and at-home assignments. Groups will contain 5-8 participants who are active-duty Soldiers enrolled in either Respect-MIL or the Interdisciplinary Pain Management Center (IPMC). Receives: Behavioral: Relaxation Response training |
| Standard of Care | No intervention | Participants randomized to the control group will receive standard care through their providers at Respect-MIL or at the IPMC. Participants randomized to the control group will remain on the wait list for further standard care. After the collection of the final data point, these participants will also have the option to participate in an abbreviated, two-hour version of the RR training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep
Sleep will be measured pre and post intervention. Sleep will be measured by the Pittsburgh Sleep Quality Index (PSQI). The PSQI assesses sleep quality and disturbances during the past month based on seven component scores for sleep quality, latency, duration, efficiency, disturbance, medication use, and daytime dysfunction that sum to a global score. A Sleep Diary will also be used to measure sleep and related factors.
Measured: 6 weeks
Secondary outcomes (4)
Anger
Anger, measured with the Spielberger State-Trait Anger Expression Inventory-2 (STAXI-2)
Measured: 6 Weeks
Health Status
Health Status as measured with the Veterans RAND 12-item Health Survey Short Form (VR-12 or SF-12) and the Functional Assessment of Chronic Illness Therapy- Spiritual Well-Being 12 (Non-Illness)
Measured: 6 Weeks
Resilience
Resilience will be measured with the Post Traumatic Growth Inventory
Measured: 6 Weeks
Stress
Stress as measured with physiological measurements of blood pressure and heart rate (pulse) and subjective measurement using the Perceived Stress Scale
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2012 (estimated)
- Study startJul 2012
- Primary completionMay 2015
- Study completionMay 2015
Why it stopped: Loss of staff for completion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- William Beaumont Army Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Richard P Petri, MD, Principal investigator, William Beaumont Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01725854
- Sponsor's protocol ID
- W81XWH-10-1-1011/ 367294
- Acronym
- RR
- Status last verified
- Oct 2016
- First submitted
- 9 Nov 2012
- Last updated
- 2 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: Study terminated
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relaxation Response (RR) Training for PTSD Prevention in Soldiers a.k.a. "SPIRIT SMART" (Stemming PTSD, Increasing Resilience and Impeding Trauma in Service Members: Assessing Relaxation Response Training)
- ClinicalTrials.gov ID
- NCT01725854
- Acronym / sponsor ID
- RR / W81XWH-10-1-1011/ 367294
- Conditions
- Posttraumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Loss of staff for completion
- Enrolment
- 8 participants (actual)
- Lead sponsor
- William Beaumont Army Medical CenterUS federal agency
- Study start
- Jul 2012
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 14 Nov 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 purposes of this study are to evaluate the acceptability and utility of a mind-body intervention on a convenience sample of Soldiers (n=120) who have screened positive through RESPECT-MIL for symptoms that may lead to post-traumatic stress and to test the effectiveness of this Relaxation Response (RR) intervention designed to decrease the physiological and psychosocial effects of stress and trauma. The study aims to enhance the psychological health of Soldiers with a RR intervention designed to promote self-awareness of physiological responses to stress and the ability to increase relaxation responses.
Detailed description
Specific Aims:
- Demonstrate that trainers can be trained effectively to deliver the intervention, a mind-body skills training program based on the Benson-Henry Institute's standard RR training curriculum and tailored to a military population.
- Evaluate feasibility, acceptability, and compliance to the training program in an active duty military population.
- Compare outcomes on sleep disturbance, PTSD, stress-related symptoms, quality of life, and psychosocial variables related to resilience of Soldiers who receive the 6-week training program to promote the Relaxation Response to those Soldiers who do not receive the intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Relaxation Response Training | Experimental | Behavioral: Relaxation Response trainingThe Military tailored RR training program will consist of six weekly small group sessions which involve group presentations, in-group skill building exercises, and at-home assignments. Groups will contain 5-8 participants who are active-duty Soldiers enrolled in either Respect-MIL or the Interdisciplinary Pain Management Center (IPMC). |
| Standard of Care | No intervention | –Participants randomized to the control group will receive standard care through their providers at Respect-MIL or at the IPMC. Participants randomized to the control group will remain on the wait list for further standard care. After the collection of the final data point, these participants will also have the option to participate in an abbreviated, two-hour version of the RR training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years or older, male and female volunteer individual military Service Members, DoD civilians or approved contractors working for DoD, primarily from multidisciplinary healthcare providers.
- Willingness to participate in the research project.
- Committed to the entire period of time of the research project.
- Currently working or stationed at Ft Bliss, Texas.
- No impending orders for deployment/ TDY/ PCS/ ETS or retirement for at least 8 weeks from the day of study enrollment.
Key exclusion criteria (1 listed)
- Diagnosed with severe PTSD or other mental health issues disclosed as self-reported
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 |
|---|---|---|
| Relaxation Response trainingAlso: Benson-Henry Institute Relaxation response trainingBehavioral Relaxation Response Training (Benson-Henry Institute Relaxation Response Training) Participants randomized to the intervention group will participate in the six weekly RR sessions. Examples of in-group skill building exercises are mini relaxations, diaphragmatic breathing, introduction to imagery, and eliciting RR through Yoga. Presentations topics include Introduction to Mind/Body Medicine, Introduction to the RR, Experiential RR Sessions, and Introduction to Cognitive Restructuring. Home skill building assignments include relaxation focus practice, an appreciation journal, self-monitoring with Biodots (biosensor technology that helps participants to monitor and regulate their psycho-emotional state), physical activity, balanced nutrition, and progress notes. | Behavioural | Relaxation Response Training |
Primary outcome
Sleep
Time frame: 6 weeks
Sleep will be measured pre and post intervention. Sleep will be measured by the Pittsburgh Sleep Quality Index (PSQI). The PSQI assesses sleep quality and disturbances during the past month based on seven component scores for sleep quality, latency, duration, efficiency, disturbance, medication use, and daytime dysfunction that sum to a global score. A Sleep Diary will also be used to measure sleep and related factors.
4 secondary outcomes
Anger
Time frame: 6 Weeks
Health Status
Time frame: 6 Weeks
Resilience
Time frame: 6 Weeks
Stress
Time frame: 6 Weeks
Results and safety
The study was stopped early (reason given: Loss of staff for completion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
- Individual participant dataSharing planned: Undecided. Study terminated
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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.
Richard P Petri, MD principal investigator
William Beaumont Army Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relaxation Response training in people with Posttraumatic Stress Disorder, run by William Beaumont Army Medical Center 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 7 inclusion and 1 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: stopped early, as of the sponsor's last update on 2 Nov 2016. 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. 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 was stopped early (reason given: Loss of staff for completion). Results are not available in the source record.
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?
Sleep (time frame: 6 weeks). 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 2 Nov 2016.