NCT01348750

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 5, 2011

Completed
Last Updated

May 5, 2011

Status Verified

May 1, 2011

Enrollment Period

2 years

First QC Date

May 3, 2011

Last Update Submit

May 4, 2011

Conditions

Keywords

PTSDHealing TouchGuided ImageryMilitaryComplementary Medicine

Outcome Measures

Primary Outcomes (1)

  • 17-item PTSD Checklist (Military)is used to determine the effect of the intervention

    After 6 treatments of healing touch and guided imagery

Secondary Outcomes (3)

  • Depression (Beck Depression Inventory)

    After 6 treatments of healing touch and guided imagery

  • Quality of Life (SF36)

    After 6 treatments of healing touch and guided imagery

  • Hostility (Cook-Medley Hostility Inventory)

    After 6 treatments of healing touch and guided

Study Arms (2)

Group A

OTHER

This group receives 6 Healing Touch \& Guided Imagery treatments in addition to standard medical care.

Other: Healing Touch & Guided Imagery

Group B

NO INTERVENTION

This group receives standard medical care but NO Healing Touch and Guided Imagery.

Interventions

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.

Group A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Scripps Center for Integrative Medicine

La Jolla, California, 92037, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

TouchImagery, Psychotherapy

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

SensationNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaMind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Erminia M Guarneri, MD

    Scripps Center for Integrative Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 3, 2011

First Posted

May 5, 2011

Study Start

July 1, 2008

Primary Completion

July 1, 2010

Study Completion

August 1, 2010

Last Updated

May 5, 2011

Record last verified: 2011-05

Locations