Posttraumatic Stress DisorderNCT00784771
Hypnotherapeutic Olfactory Conditioning for Posttraumatic Stress Disorder (PTSD)
A study testing Hypnotherapeutic Olfactory Conditioning (HOC) in people with Posttraumatic Stress Disorder, run by Herzog Hospital at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Hypnotherapeutic Olfactory Conditioning (HOC)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 36 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2005to Feb 2007
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Flashbacks and/or panic attacks with olfactory components
- Prior attempt at treatment with unsatisfactory results
- Competence and agreement to sign an informed consent.
Who cannot join
- Evidence of psychosis
- Severe traumatic brain injury
- Post-concussion syndrome
- Uncontrolled substance abuse.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Combat Stress Reaction Unit, Medical Corps, Mental Health Department, Israel Defense Forces
Tel HaShomer, Ramat Gan, 71700
About this study
Official title: Hypnotherapeutic Olfactory Conditioning for Chronic Combat-Related Posttraumatic Stress Disorder
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.
Read the detailed 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.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Hypnotherapeutic Olfactory Conditioning (HOC)
- Keywords
- Hypnotherapy, Hypnosis, PTSD
- 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.
Hypnotherapeutic Olfactory Conditioning (HOC)Behavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of Event Scale
Measured: Baseline, 6 weeks, 6 months, one year
Secondary outcomes (2)
Beck Depression Inventory
Measured: Baseline, 6 weeks, 6 months, one year
Dissociative Experience Scale
Measured: Baseline, 6 weeks, 6 months, one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2008 (estimated)
- Study startJan 2005
- Primary completionFeb 2007
- Study completionFeb 2007
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herzog Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00784771
- Sponsor's protocol ID
- lichtenberg4 CTIL
- Status last verified
- Nov 2008
- First submitted
- 3 Nov 2008
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypnotherapeutic Olfactory Conditioning for Chronic Combat-Related Posttraumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT00784771
- Acronym / sponsor ID
- lichtenberg4 CTIL
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- Hypnotherapy, Hypnosis, PTSD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Herzog HospitalUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 4 Nov 2008 (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.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
- Flashbacks and/or panic attacks with olfactory components
- Prior attempt at treatment with unsatisfactory results
- Competence and agreement to sign an informed consent.
Key exclusion criteria (4 listed)
- Evidence of psychosis
- Severe traumatic brain injury
- Post-concussion syndrome
- Uncontrolled substance abuse.
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 |
|---|---|---|
| Hypnotherapeutic Olfactory Conditioning (HOC) | Behavioural | – |
Primary outcome
Impact of Event Scale
Time frame: Baseline, 6 weeks, 6 months, one year
2 secondary outcomes
Beck Depression Inventory
Time frame: Baseline, 6 weeks, 6 months, one year
Dissociative Experience Scale
Time frame: Baseline, 6 weeks, 6 months, one year
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 20 Nov 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnotherapeutic Olfactory Conditioning (HOC) in people with Posttraumatic Stress Disorder, run by Herzog Hospital at 1 site in Israel.
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 4 inclusion and 4 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 20 Nov 2015. 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 Israel. 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?
Impact of Event Scale (time frame: Baseline, 6 weeks, 6 months, one year). 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 20 Nov 2015.