Post-Traumatic Stress DisorderNCT01348750
Healing Touch & Guided Imagery for Posttraumatic Stress Disorder Symptoms
A study testing Healing Touch & Guided Imagery in people with Post-Traumatic Stress Disorder, run by Scripps Center for Integrative Medicine at 1 site in United States.
Trial summary
This is a randomized controlled 2 year trial at Camp Pendleton, CA to determine whether a complementary medicine intervention (Healing Touch with Guided Imagery, HT+GI) reduces Posttraumatic Stress Disorder (PTSD) symptoms as compared to treatment as usual (TAU) in returning combat-exposed active duty military with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Traumatic Stress Disorder
- What is being tested?
- Healing Touch & Guided Imagery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Aug 2010
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female or male subjects 18 years or older
- Post-deployment from a combat zone
- Identified by post-deployment health re-assessment to have PTSD symptoms
- Referred by Camp Pendleton
- Subjects who are willing to sign a consent
- Subjects who are willing to participate for the length of the study
Show all 10Show fewer
- Exclusions:
- Female subjects who are now pregnant or nursing
- Subjects who are receiving healing touch or using guided imagery from other sources
- Subjects who have any major health condition that may interfere with participating in this study
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Scripps Center for Integrative Medicine
La Jolla, California, 92037
About this study
Official title: Healing Touch and Guided Imagery Intervention in Post-deployment Military Personnel With Posttraumatic Stress Disorder Symptoms
This is a randomized controlled 2 year trial at Camp Pendleton, CA to determine whether a complementary medicine intervention (Healing Touch with Guided Imagery, HT+GI) reduces Posttraumatic Stress Disorder (PTSD) symptoms as compared to treatment as usual (TAU) in returning combat-exposed active duty military with significant PTSD symptoms. Secondary aims will evaluate the effect of HT and GI on measures of depression, hostility, and general health status in this population.
Read the detailed description
The study enrolled 123 active duty subjects from the Marine Corps Base Camp Pendleton in Southern California with at least one or more symptoms of PTSD .
- Conditions
- Post-Traumatic Stress Disorder
- Being tested
- Healing Touch & Guided Imagery
- Keywords
- PTSD, Healing Touch, Guided Imagery, Military, Complementary Medicine
- 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.
Healing Touch & Guided ImageryOther
Healing Touch (HT) is an energy based approach to health and healing. It uses light touch to influence the energy field that surrounds the body, and the energy centers which control the flow of energy to the physical body.
HT complements traditional health care and is used together with other approaches to health and healing.
Guided Imagery (GI) is a form of focused relaxation used to create harmony between the mind and body. Positive mental imagery can promote relaxation, reduce stress and improve mood as well as alter heart rate, blood pressure and breathing.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Other | This group receives 6 Healing Touch \& Guided Imagery treatments in addition to standard medical care. Receives: Other: Healing Touch & Guided Imagery |
| Group B | No intervention | This group receives standard medical care but NO Healing Touch and Guided Imagery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
17-item PTSD Checklist (Military)is used to determine the effect of the intervention
Measured: After 6 treatments of healing touch and guided imagery
Secondary outcomes (3)
Depression (Beck Depression Inventory)
Measured: After 6 treatments of healing touch and guided imagery
Quality of Life (SF36)
Measured: After 6 treatments of healing touch and guided imagery
Hostility (Cook-Medley Hostility Inventory)
Measured: After 6 treatments of healing touch and guided
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2011 (estimated)
- Study startJul 2008
- Primary completionJul 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Traumatic 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scripps Center for Integrative Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Marine Corps Base Camp Pendleton
- Investigators
- Erminia M Guarneri, MD, Principal investigator, Scripps Center for Integrative Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01348750
- Sponsor's protocol ID
- PTSD_HSC07_4684
- Status last verified
- May 2011
- First submitted
- 3 May 2011
- Last updated
- 5 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healing Touch and Guided Imagery Intervention in Post-deployment Military Personnel With Posttraumatic Stress Disorder Symptoms
- ClinicalTrials.gov ID
- NCT01348750
- Acronym / sponsor ID
- PTSD_HSC07_4684
- Conditions
- Post-Traumatic Stress Disorder
- Keywords
- PTSD, Healing Touch, Guided Imagery, Military, Complementary Medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Scripps Center for Integrative MedicineUniversity, hospital or other
- Collaborators
- Marine Corps Base Camp Pendleton
- Study start
- Jul 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 5 May 2011 (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.
This is a randomized controlled 2 year trial at Camp Pendleton, CA to determine whether a complementary medicine intervention (Healing Touch with Guided Imagery, HT+GI) reduces Posttraumatic Stress Disorder (PTSD) symptoms as compared to treatment as usual (TAU) in returning combat-exposed active duty military with significant PTSD symptoms. Secondary aims will evaluate the effect of HT and GI on measures of depression, hostility, and general health status in this population.
Detailed description
The study enrolled 123 active duty subjects from the Marine Corps Base Camp Pendleton in Southern California with at least one or more symptoms of PTSD .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Other | Other: Healing Touch & Guided ImageryThis group receives 6 Healing Touch \& Guided Imagery treatments in addition to standard medical care. |
| Group B | No intervention | –This group receives standard medical care but NO Healing Touch and Guided Imagery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Female or male subjects 18 years or older
- Post-deployment from a combat zone
- Identified by post-deployment health re-assessment to have PTSD symptoms
- Referred by Camp Pendleton
- Subjects who are willing to sign a consent
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Healing Touch & Guided ImageryHealing Touch (HT) is an energy based approach to health and healing. It uses light touch to influence the energy field that surrounds the body, and the energy centers which control the flow of energy to the physical body. HT complements traditional health care and is used together with other approaches to health and healing. Guided Imagery (GI) is a form of focused relaxation used to create harmony between the mind and body. Positive mental imagery can promote relaxation, reduce stress and improve mood as well as alter heart rate, blood pressure and breathing. | Other | Group A |
Primary outcome
17-item PTSD Checklist (Military)is used to determine the effect of the intervention
Time frame: After 6 treatments of healing touch and guided imagery
3 secondary outcomes
Depression (Beck Depression Inventory)
Time frame: After 6 treatments of healing touch and guided imagery
Quality of Life (SF36)
Time frame: After 6 treatments of healing touch and guided imagery
Hostility (Cook-Medley Hostility Inventory)
Time frame: After 6 treatments of healing touch and guided
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 5 May 2011.
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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.
Erminia M Guarneri, MD principal investigator
Scripps Center for Integrative Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healing Touch & Guided Imagery in people with Post-Traumatic Stress Disorder, run by Scripps Center for Integrative Medicine 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 10 inclusion and 0 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 5 May 2011. 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 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?
17-item PTSD Checklist (Military)is used to determine the effect of the intervention (time frame: After 6 treatments of healing touch and guided imagery). 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 5 May 2011.