Posttraumatic Stress DisorderNCT00691626
Cognitive Behavioral Therapy (CBT) for Nightmares in Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans
A study testing CBT for Insomnia plus Imagery Rehearsal and CBT for Insomnia plus psychoeducation in people with Posttraumatic Stress Disorder and Sleep Disorders, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The purpose of this study is to compare the effectiveness of two talk therapies for OEF/OIF Veterans at the Michael J. Crescenz and the West Haven VA Medical Centers. Participants will randomly receive one of two individual treatments intended to improve the sleep disturbance and nightmares of returning Veterans. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Posttraumatic Stress Disorder, Sleep Disorders, Nightmares
- What is being tested?
- CBT for Insomnia plus Imagery Rehearsal and CBT for Insomnia plus psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2009to 31 Dec 2019
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Currently enrolled in treatment in the Michael J. Crescenz VA Medical Center or VA Connecticut Healthcare System Mental Health Clinic
- Meets DSM-IV-R criteria for current PTSD (within the past month)
- Repetitive, military-related nightmares (at least 1 every 2 weeks, for at least 6 months)
- A global sleep disturbance, as indicated by a score of five or greater on the Pittsburgh Sleep Quality Index
- Ability to read and speak English
- A concurrent anxiety disorder or depressive disorder diagnosis will be allowed
- Dementia related to head injury and amnestic disorder related to head injury will be allowed
Who cannot join
- Current substance dependence
- Bipolar disorder
- Delirium
- Dementia that is not related to head injury
- Amnestic disorder that is not related to head injury
- Schizophrenia and other psychotic disorders
- Severe traumatic brain injury, as indicated by self-report (loss of consciousness or alteration of mental status greater than 24 hours, or peri-traumatic memory loss, or any posttraumatic amnesia greater than 7 days)
- The presence of diagnosed sleep disorders other than insomnia: narcolepsy, circadian rhythm sleep disorders, and periodic limb movement disorder. Participants in treatment for sleep apnea, or who have not benefited from or declined available treatment may be included.
Trial locations and contacts
1 site in 1 country.
United States1 site
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, 19104
About this study
Official title: CBT for Nightmares in OEF/OIF Veterans
The purpose of this study is to compare the effectiveness of two talk therapies for OEF/OIF Veterans at the Michael J. Crescenz and the West Haven VA Medical Centers. Participants will randomly receive one of two individual treatments intended to improve the sleep disturbance and nightmares of returning Veterans.
Read the detailed description
This is a dismantling study with the objective of determining whether imagery rehearsal is essential to the efficacy of imagery rehearsal + CBT-I for improving the sleep and nightmare disturbance in Veterans with PTSD and recurrent nightmares.
- Conditions
- Posttraumatic Stress Disorder, Sleep Disorders, Nightmares
- Being tested
- CBT for Insomnia plus Imagery Rehearsal, CBT for Insomnia plus psychoeducation
- Keywords
- posttraumatic stress, nightmares, sleep, psychotherapy, imagery rehearsal, insomnia, behavioral treatment, veterans, Operation Iraqi Freedom, Operation Enduring Freedom
- Medical subject headings
- Stress Disorders, Post-Traumatic, Sleep Wake Disorders, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT for Insomnia plus Imagery RehearsalBehavioural
patients receive standard CBT for insomnia and psychoeducation combined with techniques of imagery rehearsal aimed at reducing posttraumatic nightmare frequency and distress
CBT for Insomnia plus psychoeducationBehavioural
Also called Sleep and Nightmare Management
patients receive standard CBT for insomnia combined with psychoeducation
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: CBT for Insomnia plus Imagery Rehearsal | Experimental | CBT for Insomnia plus Imagery Rehearsal Receives: Behavioral: CBT for Insomnia plus Imagery Rehearsal |
| Arm 2: CBT for Insomnia | Active comparator | CBT for Insomnia Receives: Behavioral: CBT for Insomnia plus psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nightmare Frequency Questionnaire, Nightmare Distress Questionnaire
The NFQ measures the number of nightmares/week and the number of nights with a nightmare/week.
The NDQ measures the distress associated with nightmare experiences.
Measured: post-treatment, 3 month and 6-month follow-up
Secondary outcomes (1)
Pittsburgh Sleep Quality Index
This is a standard instrument for measuring basic sleep parameters.
Measured: post-treatment, 3 month and 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2008 (estimated)
- Study start1 Apr 2009
- Primary completion1 Jan 2015
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized controlled trial comparing two forms of psychotherapy.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Richard J. Ross, MD PhD, Principal investigator, Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PAIlan Harpaz-Rotem, PhD, Principal investigator, VA Connecticut Healthcare System West Haven Campus, West Haven, CT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00691626
- Sponsor's protocol ID
- PT074364
- Status last verified
- Jan 2020
- First submitted
- 2 Jun 2008
- Last updated
- 31 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Scott JC, Harb G, Brownlow JA, Greene J, Gur RC, Ross RJ. Verbal memory functioning moderates psychotherapy treatment response for PTSD-Related nightmares. Behav Res Ther. 2017 Apr;91:24-32. doi: 10.1016/j.brat.2017.01.004. Epub 2017 Jan 13.
PubMed 28110112Harb GC, Cook JM, Phelps AJ, Gehrman PR, Forbes D, Localio R, Harpaz-Rotem I, Gur RC, Ross RJ. Randomized Controlled Trial of Imagery Rehearsal for Posttraumatic Nightmares in Combat Veterans. J Clin Sleep Med. 2019 May 15;15(5):757-767. doi: 10.5664/jcsm.7770.
PubMed 31053215
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CBT for Nightmares in OEF/OIF Veterans
- ClinicalTrials.gov ID
- NCT00691626
- Acronym / sponsor ID
- PT074364
- Conditions
- Posttraumatic Stress Disorder, Sleep Disorders, Nightmares
- Keywords
- posttraumatic stress, nightmares, sleep, psychotherapy, imagery rehearsal, insomnia, behavioral treatment, veterans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Apr 2009 (actual)
- Primary completion
- 1 Jan 2015 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 5 Jun 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.
The purpose of this study is to compare the effectiveness of two talk therapies for OEF/OIF Veterans at the Michael J. Crescenz and the West Haven VA Medical Centers. Participants will randomly receive one of two individual treatments intended to improve the sleep disturbance and nightmares of returning Veterans.
Detailed description
This is a dismantling study with the objective of determining whether imagery rehearsal is essential to the efficacy of imagery rehearsal + CBT-I for improving the sleep and nightmare disturbance in Veterans with PTSD and recurrent nightmares.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized controlled trial comparing two forms of psychotherapy.
| Arm | Type | Receives |
|---|---|---|
| Arm 1: CBT for Insomnia plus Imagery Rehearsal | Experimental | Behavioral: CBT for Insomnia plus Imagery RehearsalCBT for Insomnia plus Imagery Rehearsal |
| Arm 2: CBT for Insomnia | Active comparator | Behavioral: CBT for Insomnia plus psychoeducationCBT for Insomnia |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Currently enrolled in treatment in the Michael J. Crescenz VA Medical Center or VA Connecticut Healthcare System Mental Health Clinic
- Meets DSM-IV-R criteria for current PTSD (within the past month)
- Repetitive, military-related nightmares (at least 1 every 2 weeks, for at least 6 months)
- A global sleep disturbance, as indicated by a score of five or greater on the Pittsburgh Sleep Quality Index
- Ability to read and speak English
Key exclusion criteria (8 listed)
- Current substance dependence
- Bipolar disorder
- Delirium
- Dementia that is not related to head injury
- Amnestic disorder that is not related to head injury
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 |
|---|---|---|
| CBT for Insomnia plus Imagery Rehearsalpatients receive standard CBT for insomnia and psychoeducation combined with techniques of imagery rehearsal aimed at reducing posttraumatic nightmare frequency and distress | Behavioural | Arm 1: CBT for Insomnia plus Imagery Rehearsal |
| CBT for Insomnia plus psychoeducationAlso: Sleep and Nightmare Managementpatients receive standard CBT for insomnia combined with psychoeducation | Behavioural | Arm 2: CBT for Insomnia |
Primary outcome
Nightmare Frequency Questionnaire, Nightmare Distress Questionnaire
Time frame: post-treatment, 3 month and 6-month follow-up
The NFQ measures the number of nightmares/week and the number of nights with a nightmare/week. The NDQ measures the distress associated with nightmare experiences.
1 secondary outcome
Pittsburgh Sleep Quality Index
Time frame: post-treatment, 3 month and 6-month follow-up
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 31 Jan 2020.
- Results publication: PubMed 28110112Scott JC, Harb G, Brownlow JA, Greene J, Gur RC, Ross RJ. Verbal memory functioning moderates psychotherapy treatment response for PTSD-Related nightmares. Behav Res Ther. 2017 Apr;91:24-32. doi: 10.1016/j.brat.2017.01.004. Epub 2017 Jan 13.
- Results publication: PubMed 31053215Harb GC, Cook JM, Phelps AJ, Gehrman PR, Forbes D, Localio R, Harpaz-Rotem I, Gur RC, Ross RJ. Randomized Controlled Trial of Imagery Rehearsal for Posttraumatic Nightmares in Combat Veterans. J Clin Sleep Med. 2019 May 15;15(5):757-767. doi: 10.5664/jcsm.7770.
- Individual participant dataSharing planned: No
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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.
Richard J. Ross, MD PhD principal investigator
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Ilan Harpaz-Rotem, PhD principal investigator
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT for Insomnia plus Imagery Rehearsal and CBT for Insomnia plus psychoeducation in people with Posttraumatic Stress Disorder and Sleep Disorders, run by VA Office of Research and Development 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 7 inclusion and 8 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 31 Jan 2020. 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 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?
Nightmare Frequency Questionnaire, Nightmare Distress Questionnaire (time frame: post-treatment, 3 month and 6-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00691626, which also lists 2 linked publications.
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 31 Jan 2020; AzTrials last refreshed its copy on 6 Nov 2026.