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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01348750
Other study ID # PTSD_HSC07_4684
Secondary ID
Status Completed
Phase N/A
First received May 3, 2011
Last updated May 4, 2011
Start date July 2008
Est. completion date August 2010

Study information

Verified date May 2011
Source Scripps Center for Integrative Medicine
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical 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 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.


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 .


Recruitment information / eligibility

Status Completed
Enrollment 123
Est. completion date August 2010
Est. primary completion date July 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Female or male subjects 18 years or older

2. Post-deployment from a combat zone

3. Identified by post-deployment health re-assessment to have PTSD symptoms

4. Referred by Camp Pendleton

5. Subjects who are willing to sign a consent

6. Subjects who are willing to participate for the length of the study

Exclusions:

1. Female subjects who are now pregnant or nursing

2. Subjects who are receiving healing touch or using guided imagery from other sources

3. Subjects who have any major health condition that may interfere with participating in this study

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment


Intervention

Other:
Healing Touch & Guided Imagery
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.

Locations

Country Name City State
United States Scripps Center for Integrative Medicine La Jolla California

Sponsors (2)

Lead Sponsor Collaborator
Scripps Center for Integrative Medicine Marine Corps Base Camp Pendleton California

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 17-item PTSD Checklist (Military)is used to determine the effect of the intervention After 6 treatments of healing touch and guided imagery No
Secondary Depression (Beck Depression Inventory) After 6 treatments of healing touch and guided imagery No
Secondary Quality of Life (SF36) After 6 treatments of healing touch and guided imagery No
Secondary Hostility (Cook-Medley Hostility Inventory) After 6 treatments of healing touch and guided No
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