Stress Disorders, Post-TraumaticNCT00837382
Imagery Rescripting for Posttraumatic Nightmares in Rural Operation Enduring Freedom (OEF)/Operation Iraqi Freedom (OIF) Veterans With Posttraumatic Stress Disorder (PTSD)
A study testing MEDVAMC Nightmare Treatment and Telepsychiatry Nightmare Treatment in people with Stress Disorders, Post-Traumatic and Sleep Disorders, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
Many service members returning from Iraq and Afghanistan have difficulties adjusting back to civilian life. Research shows that symptoms of posttraumatic stress disorder (PTSD) are particularly high in returning Operation Enduring Freedom (OEF)/Operation Iraqi Freedom (OIF) veterans, and that combat-related nightmares… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Stress Disorders, Post-Traumatic, Sleep Disorders
- What is being tested?
- MEDVAMC Nightmare Treatment and Telepsychiatry Nightmare Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to 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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients for the open trial will be
- OEF/OIF veterans (aged 18-64);
- English-speaking;
- currently enrolled in the Trauma Recovery Program (TRP) at the Michael E. DeBakey Veteran Affairs Medical Center (MEDVAMC);
- reporting at least one combat or war zone associated PTNM in the past week;
- have an existing PTSD International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM); and
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- consenting to be in an open trial for treatment of PTNM. In addition, patients must agree to allow their assessment and therapy sessions to be video/audiotaped for the purposes of supervision.
- Pilot Study: Patients for the pilot study will be
- OEF/OIF veterans (aged 18-64);
- English-speaking;
- currently enrolled in the Conroe CBOC for their primary or mental health care;
- reporting at least one combat or war zone associated PTNM in the past week;
- have an existing PTSD ICD-9-CM diagnosis; and
- consenting to be in the pilot study for treatment of PTNM. In addition, patients must agree to allow their assessment and therapy sessions to be video/audiotaped for the purposes of supervision.
Who cannot join
- Patients will be excluded for the following reasons:
- current active suicidal/homicidal ideation and intent;
- current substance dependence;
- a diagnosis of bipolar or psychosis;
- active participation in another psychosocial treatment for PTSD;
- prescribed the medication Prazosin (a psychotropic medication for the treatment of nightmares).
- Patients interested in receiving the intervention will not be excluded if they are taking psychotropic medication (except for Prazosin) and may continue to take their medication as prescribed throughout the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Michael E. DeBakey VA Medical Center (152)
Houston, Texas, 77030
About this study
Many service members returning from Iraq and Afghanistan have difficulties adjusting back to civilian life. Research shows that symptoms of posttraumatic stress disorder (PTSD) are particularly high in returning Operation Enduring Freedom (OEF)/Operation Iraqi Freedom (OIF) veterans, and that combat-related nightmares and sleep disturbances are common in veterans with PTSD. This is of concern because people with these problems will often use unhealthy ways of coping. Although combat-related nightmares and difficulty sleeping are highly distressing, there are helpful treatments that do not involve taking medication. One of these treatments teaches specific skills to help people improve their sleep habits and to change their nightmares so that they are less upsetting. This treatment can be very helpful and research shows that people experience decreases in the frequency and severity of their nightmares, decreased symptoms of depression and PTSD, and improved sleep quality and quantity after completing treatment. However, because this treatment has only been studied with civilians, it is not clear how well this treatment works for returning veterans. This study tests how well this treatment works in treating combat nightmares in veterans who also have PTSD from experiencing a traumatic event.
- Conditions
- Stress Disorders, Post-Traumatic, Sleep Disorders
- Being tested
- MEDVAMC Nightmare Treatment, Telepsychiatry Nightmare Treatment
- Medical subject headings
- Stress Disorders, Post-Traumatic, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDVAMC Nightmare TreatmentBehavioural
Veteran Nightmare Treatment Using Imagery Rescripting
Telepsychiatry Nightmare TreatmentBehavioural
Veteran Nightmare Treatment Using Imagery Rescripting Through Videoconferencing
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | MEDVAMC Nightmare Treatment Receives: Behavioral: MEDVAMC Nightmare Treatment |
| 2 | Experimental | Videoconferencing nightmare Treatment Receives: Behavioral: Telepsychiatry Nightmare Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician Administered PTSD Scale (CAPS), Posttraumatic Stress Symptom Scale-Self-Report (PSS-SR) & Beck Depression Inventory-II (BDI-II)
Measured: Baseline & post-treatment
Secondary outcomes (6)
Posttraumatic Cognitions Inventory (PTCI).
Measured: Baseline & post-treatment
The Pittsburgh Sleep Quality Index-Addendum for PTSD (PSQI)
Measured: Baseline & post-treatment
Trauma Related Nightmare Survey (TRNS).
Measured: Baseline & post-treatment
Mini-International Neuropsychiatric Interview (MINI)
Measured: Baseline
Treatment Evaluation Inventory (TEI)
Measured: Post-treatment
Client Satisfaction Questionnaire (CSQ)
Measured: Post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2009 (estimated)
- Study startJan 2010
- Primary completionAug 2010
- Study completionAug 2010
Why it stopped: Primary investigator is no longer a part of the VA.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Disorders, Post-TraumaticStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Investigators
- Mary E. Long, PhD, Principal investigator, Michael E. DeBakey VA Medical Center (152)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00837382
- Sponsor's protocol ID
- H-24157
- Status last verified
- Sep 2010
- First submitted
- 3 Feb 2009
- Last updated
- 29 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imagery Rescripting for Posttraumatic Nightmares in Rural Operation Enduring Freedom (OEF)/Operation Iraqi Freedom (OIF) Veterans With Posttraumatic Stress Disorder (PTSD)
- ClinicalTrials.gov ID
- NCT00837382
- Acronym / sponsor ID
- H-24157
- Conditions
- Stress Disorders, Post-Traumatic, Sleep Disorders
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Primary investigator is no longer a part of the VA.
- Enrolment
- 7 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Jan 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 5 Feb 2009 (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.
Many service members returning from Iraq and Afghanistan have difficulties adjusting back to civilian life. Research shows that symptoms of posttraumatic stress disorder (PTSD) are particularly high in returning Operation Enduring Freedom (OEF)/Operation Iraqi Freedom (OIF) veterans, and that combat-related nightmares and sleep disturbances are common in veterans with PTSD. This is of concern because people with these problems will often use unhealthy ways of coping. Although combat-related nightmares and difficulty sleeping are highly distressing, there are helpful treatments that do not involve taking medication. One of these treatments teaches specific skills to help people improve their sleep habits and to change their nightmares so that they are less upsetting. This treatment can be very helpful and research shows that people experience decreases in the frequency and severity of their nightmares, decreased symptoms of depression and PTSD, and improved sleep quality and quantity after completing treatment. However, because this treatment has only been studied with civilians, it is not clear how well this treatment works for returning veterans. This study tests how well this treatment works in treating combat nightmares in veterans who also have PTSD from experiencing a traumatic event.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: MEDVAMC Nightmare TreatmentMEDVAMC Nightmare Treatment |
| 2 | Experimental | Behavioral: Telepsychiatry Nightmare TreatmentVideoconferencing nightmare Treatment |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Patients for the open trial will be
- OEF/OIF veterans (aged 18-64);
- English-speaking;
- currently enrolled in the Trauma Recovery Program (TRP) at the Michael E. DeBakey Veteran Affairs Medical Center (MEDVAMC);
- reporting at least one combat or war zone associated PTNM in the past week;
Key exclusion criteria (7 listed)
- current active suicidal/homicidal ideation and intent;
- current substance dependence;
- a diagnosis of bipolar or psychosis;
- active participation in another psychosocial treatment for PTSD;
- prescribed the medication Prazosin (a psychotropic medication for the treatment of nightmares).
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 |
|---|---|---|
| MEDVAMC Nightmare TreatmentVeteran Nightmare Treatment Using Imagery Rescripting | Behavioural | 1 |
| Telepsychiatry Nightmare TreatmentVeteran Nightmare Treatment Using Imagery Rescripting Through Videoconferencing | Behavioural | 2 |
Primary outcome
Clinician Administered PTSD Scale (CAPS), Posttraumatic Stress Symptom Scale-Self-Report (PSS-SR) & Beck Depression Inventory-II (BDI-II)
Time frame: Baseline & post-treatment
6 secondary outcomes
Posttraumatic Cognitions Inventory (PTCI).
Time frame: Baseline & post-treatment
The Pittsburgh Sleep Quality Index-Addendum for PTSD (PSQI)
Time frame: Baseline & post-treatment
Trauma Related Nightmare Survey (TRNS).
Time frame: Baseline & post-treatment
Mini-International Neuropsychiatric Interview (MINI)
Time frame: Baseline
Treatment Evaluation Inventory (TEI)
Time frame: Post-treatment
Client Satisfaction Questionnaire (CSQ)
Time frame: Post-treatment
Results and safety
The study was stopped early (reason given: Primary investigator is no longer a part of the VA.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2010.
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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.
Mary E. Long, PhD principal investigator
Michael E. DeBakey VA Medical Center (152)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MEDVAMC Nightmare Treatment and Telepsychiatry Nightmare Treatment in people with Stress Disorders, Post-Traumatic and Sleep Disorders, run by US Department of Veterans Affairs 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 14 inclusion and 7 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: stopped early, as of the sponsor's last update on 29 Sep 2010. 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 was stopped early (reason given: Primary investigator is no longer a part of the VA.). Results are not available in the source record.
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?
Clinician Administered PTSD Scale (CAPS), Posttraumatic Stress Symptom Scale-Self-Report (PSS-SR) & Beck Depression Inventory-II (BDI-II) (time frame: Baseline & post-treatment). 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 29 Sep 2010.