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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00784771
Other study ID # lichtenberg4 CTIL
Secondary ID
Status Completed
Phase N/A
First received November 3, 2008
Last updated November 19, 2015
Start date January 2005
Est. completion date February 2007

Study information

Verified date November 2008
Source Herzog Hospital
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial Summary

Chronic combat-related posttraumatic stress disorder can be difficult to treat. The investigators believe that hypnosis, with a stress on the sensation of scent which often plays a role in the traumatic memories, can offer help for victims of this disorder who continue to suffer after receiving other treatments.


Description:

Our study examines the effect of hypnosis upon 36 individuals who suffer from posttraumatic stress disorder incurred in battles or training. The hypnotherapy stresses elements of odor, both in conditioning the subject to relate certain pleasant odors with security and calm, and in gradually reexposing the patient to the olfactory aspects of the traumatic memories. All subjects are taken form the Israel Defense Forces Mental Health Clinic, treated with 6 one-and-a-half-hour hypnotherapy sessions, and evaluated at baseline, end of treatment, after 6 months, and after 12 months, on a battery of clinical scales.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date February 2007
Est. primary completion date February 2007
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. A diagnosis of chronic combat-related PTSD according to DSM-IV criteria (APA, 1994), as determined by semi-structured psychiatric interview conducted by a psychiatrist with over ten years of experience treating PTSD

2. Flashbacks and/or panic attacks with olfactory components

3. Prior attempt at treatment with unsatisfactory results

4. Competence and agreement to sign an informed consent.

Exclusion Criteria:

1. Evidence of psychosis

2. Severe traumatic brain injury

3. Post-concussion syndrome

4. Uncontrolled substance abuse.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Behavioral:
Hypnotherapeutic Olfactory Conditioning (HOC)


Locations

Country Name City State
Israel Combat Stress Reaction Unit, Medical Corps, Mental Health Department, Israel Defense Forces Tel Hashomer Ramat Gan

Sponsors (1)

Lead Sponsor Collaborator
Herzog Hospital

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Impact of Event Scale Baseline, 6 weeks, 6 months, one year No
Secondary Beck Depression Inventory Baseline, 6 weeks, 6 months, one year No
Secondary Dissociative Experience Scale Baseline, 6 weeks, 6 months, one year No
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