Post-traumatic Stress DisorderNCT00108628
Cognitive Behavioral Treatments for Post-traumatic Stress Disorder (PTSD) Sleep Disturbance
A study testing Imagery Rehearsal and Sleep and Nightmare Management in people with Post-traumatic Stress Disorder, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
The purpose of this study is to compare the effectiveness of two cognitive behavioral group psychotherapy interventions in controlling the subjective sleep disturbance in veterans with Post-traumatic Stress Disorder. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Post-traumatic Stress Disorder
- What is being tested?
- Imagery Rehearsal and Sleep and Nightmare Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2004to Jul 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male
- Vietnam Combat Veteran
- Diagnosis of combat-related PTSD
- Stable psychotropic regimen for a minimum of three months
- Experiences recurrent nightmares
Who cannot join
- Bipolar disorder, delirium, dementia, amnestic and other cognitive disorders
- Schizophrenia and other psychotic disorders
- Substance abuse or dependence within the last six months
- Untreated medical disorders known to impact sleep
Trial locations and contacts
1 site in 1 country.
United States1 site
Philadelphia VA Medical Center
Philadelphia, Pennsylvania, 19104
About this study
Official title: 7857 Cognitive - Behavioral Treatments for PTSD Sleep Disturbance
The purpose of this study is to compare the effectiveness of two cognitive behavioral group psychotherapy interventions in controlling the subjective sleep disturbance in veterans with Post-traumatic Stress Disorder.
Read the detailed description
Repetitive, stereotypical nightmares and insomnia commonly characterize post-traumatic stress disorder (PTSD). Identifying the pathophysiological mechanisms of disrupted sleep in PTSD has therefore assumed considerable clinical importance. We previously reported an increase in rapid eye movement activity (REM activity) during REM sleep (REMS) in Vietnam War combat veterans with PTSD, and this finding can be seen as consistent with the view that most, although not all, dreaming occurs during REMS and the repeated observation that REM activity correlates with the intensity of dream mentation. There is a growing body of evidence that post-traumatic nightmares can respond to psychological treatment interventions. Namely, a cognitive-behavioral technique entitled imagery rehearsal (IR) has been reported to be effective in the treatment of such nightmares in victims of crime and in women who have been sexually assaulted. In a small pilot study, it has also been reported to be effective in the treatment of Vietnam veterans with combat-related PTSD. The two objectives of this proposal are: 1. To compare, in a study with random assignment and a parallel group design, the effectiveness in controlling the subjective sleep disturbance in veterans with PTSD of IR and Sleep and Nightmare Management (SN), a psychological treatment that targets life stressors and problems with sleep hygiene that may exacerbate insomnia and nightmares. 2. In a subset of these subjects, to compare the effectiveness in reducing REM activity of IR and SN.
- Conditions
- Post-traumatic Stress Disorder
- Being tested
- Imagery Rehearsal, Sleep and Nightmare Management
- Keywords
- Imagery, Nightmares, Post-Traumatic Stress Disorder, Psychotherapy
- 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.
Imagery RehearsalBehavioural
IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime.
Sleep and Nightmare ManagementBehavioural
This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Imagery Rehearsal Therapy Receives: Behavioral: Imagery Rehearsal |
| Arm 2 | Active comparator | Sleep and Nightmare Management Receives: Behavioral: Sleep and Nightmare Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weekly Number of Nightmares
Measured: Baseline and 1, 3, and 6 months post-treatment
Weekly Nights With a Nightmare
Measured: Baseline and 1, 3, and 6 months post-treatment
Pittsburgh Sleep Quality Index
Total scores range from 0 to 21, with higher values indicating poorer sleep quality. A score greater than 5 distinguishes between poor and good sleepers.
Measured: Baseline and 1, 3, and 6 months post-treatment
Secondary outcomes (7)
Pittsburgh Sleep Quality Index - Addendum
The PSQI-A is a measure of PTSD-related sleep and dream disturbances. Scores can range from 0 to 21, with higher scores reflecting greater sleep problems.
Measured: Baseline and 1, 3, and 6 months post-treatment
Nightmare Effects Survey
This self-report questionnaire assesses psychosocial impairment attributed to nightmares. Eleven self-report questions are rated on a scale of zero to four. The individual scores are summed to produce a total score ranging from 0 to 44 (reported in the Table). Higher scores reflect greater impairment.
Measured: Baseline and 1, 3, and 6 months post-treatment
PTSD Military Checklist
Seventeen items indicating the 17 DSM-IV criteria for PTSD are rated on a 5-point scale, from 1 to 5. Scores range from 17 to 85, with a higher score indicating greater symptom severity.
Measured: Baseline and 1, 3, and 6 months post-treatment
Beck Depression Inventory
Twenty-one items are rated on a 4-point scale. Total scores range from zero to 63, with higher scores indicating more severe depression.
Measured: Baseline and 1, 3, and 6 months post-treatment
SF-36 Physical Component
The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Scales 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Scores on each scale are summed and averaged (range = 0 "worst"-100 "best").
Measured: Baseline and 1, 3, and 6 months post-treatment
SF-36 Mental Component
The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Scales 5-8 primarily contribute to the mental component summary score (PCS) of the SF-36. Scores on each scale are summed and averaged (range = 0 "worst"-100 "best").
Measured: Baseline and 1, 3, and 6 months post-treatment
Clinician-Administered PTSD Scale (CAPS)
Seventeen questions assess the frequency and intensity of PTSD symptoms. Scores range from zero to 136, with a higher score indicating more severe symptoms.
Measured: Baseline and 1 month post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2005 (estimated)
- Study startApr 2004
- Primary completionSep 2008
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Post-traumatic 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Richard J. Ross, MD PhD, Principal investigator, Corporal Michael J. Crescenz VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00108628
- Sponsor's protocol ID
- CLIN-018-03S
- Status last verified
- Feb 2015
- First submitted
- 15 Apr 2005
- Last updated
- 18 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Harb GC, Thompson R, Ross RJ, Cook JM. Combat-related PTSD nightmares and imagery rehearsal: nightmare characteristics and relation to treatment outcome. J Trauma Stress. 2012 Oct;25(5):511-8. doi: 10.1002/jts.21748. Epub 2012 Oct 9.
PubMed 23047646Cook JM, Harb GC, Gehrman PR, Cary MS, Gamble GM, Forbes D, Ross RJ. Imagery rehearsal for posttraumatic nightmares: a randomized controlled trial. J Trauma Stress. 2010 Oct;23(5):553-63. doi: 10.1002/jts.20569.
PubMed 20839311Cook JM, Thompson R, Harb GC, Ross RJ. Cognitive-behavioral treatment for posttraumatic nightmares: An investigation of predictors of dropout and outcome. Psychological trauma : theory, research, practice and policy. 2013 Nov 1; 5(6):545-553.
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 7857 Cognitive - Behavioral Treatments for PTSD Sleep Disturbance
- ClinicalTrials.gov ID
- NCT00108628
- Acronym / sponsor ID
- CLIN-018-03S
- Conditions
- Post-traumatic Stress Disorder
- Keywords
- Imagery, Nightmares, Post-Traumatic Stress Disorder, Psychotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Apr 2004
- Primary completion
- Sep 2008 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 18 Apr 2005 (estimated)
- Results
- Posted 18 Feb 2015
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 cognitive behavioral group psychotherapy interventions in controlling the subjective sleep disturbance in veterans with Post-traumatic Stress Disorder.
Detailed description
Repetitive, stereotypical nightmares and insomnia commonly characterize post-traumatic stress disorder (PTSD). Identifying the pathophysiological mechanisms of disrupted sleep in PTSD has therefore assumed considerable clinical importance. We previously reported an increase in rapid eye movement activity (REM activity) during REM sleep (REMS) in Vietnam War combat veterans with PTSD, and this finding can be seen as consistent with the view that most, although not all, dreaming occurs during REMS and the repeated observation that REM activity correlates with the intensity of dream mentation. There is a growing body of evidence that post-traumatic nightmares can respond to psychological treatment interventions. Namely, a cognitive-behavioral technique entitled imagery rehearsal (IR) has been reported to be effective in the treatment of such nightmares in victims of crime and in women who have been sexually assaulted. In a small pilot study, it has also been reported to be effective in the treatment of Vietnam veterans with combat-related PTSD. The two objectives of this proposal are: 1. To compare, in a study with random assignment and a parallel group design, the effectiveness in controlling the subjective sleep disturbance in veterans with PTSD of IR and Sleep and Nightmare Management (SN), a psychological treatment that targets life stressors and problems with sleep hygiene that may exacerbate insomnia and nightmares. 2. In a subset of these subjects, to compare the effectiveness in reducing REM activity of IR and SN.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Behavioral: Imagery RehearsalImagery Rehearsal Therapy |
| Arm 2 | Active comparator | Behavioral: Sleep and Nightmare ManagementSleep and Nightmare Management |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Male
- Vietnam Combat Veteran
- Diagnosis of combat-related PTSD
- Stable psychotropic regimen for a minimum of three months
- Experiences recurrent nightmares
Key exclusion criteria (4 listed)
- Bipolar disorder, delirium, dementia, amnestic and other cognitive disorders
- Schizophrenia and other psychotic disorders
- Substance abuse or dependence within the last six months
- Untreated medical disorders known to impact sleep
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 |
|---|---|---|
| Imagery RehearsalIR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime. | Behavioural | Arm 1 |
| Sleep and Nightmare ManagementThis comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets | Behavioural | Arm 2 |
Primary outcome
Weekly Number of Nightmares
Time frame: Baseline and 1, 3, and 6 months post-treatment
Weekly Nights With a Nightmare
Time frame: Baseline and 1, 3, and 6 months post-treatment
Pittsburgh Sleep Quality Index
Time frame: Baseline and 1, 3, and 6 months post-treatment
Total scores range from 0 to 21, with higher values indicating poorer sleep quality. A score greater than 5 distinguishes between poor and good sleepers.
7 secondary outcomes
Pittsburgh Sleep Quality Index - Addendum
Time frame: Baseline and 1, 3, and 6 months post-treatment
Nightmare Effects Survey
Time frame: Baseline and 1, 3, and 6 months post-treatment
PTSD Military Checklist
Time frame: Baseline and 1, 3, and 6 months post-treatment
Beck Depression Inventory
Time frame: Baseline and 1, 3, and 6 months post-treatment
SF-36 Physical Component
Time frame: Baseline and 1, 3, and 6 months post-treatment
SF-36 Mental Component
Time frame: Baseline and 1, 3, and 6 months post-treatment
Clinician-Administered PTSD Scale (CAPS)
Time frame: Baseline and 1 month post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23047646Harb GC, Thompson R, Ross RJ, Cook JM. Combat-related PTSD nightmares and imagery rehearsal: nightmare characteristics and relation to treatment outcome. J Trauma Stress. 2012 Oct;25(5):511-8. doi: 10.1002/jts.21748. Epub 2012 Oct 9.
- Results publication: PubMed 20839311Cook JM, Harb GC, Gehrman PR, Cary MS, Gamble GM, Forbes D, Ross RJ. Imagery rehearsal for posttraumatic nightmares: a randomized controlled trial. J Trauma Stress. 2010 Oct;23(5):553-63. doi: 10.1002/jts.20569.
- Results publicationCook JM, Thompson R, Harb GC, Ross RJ. Cognitive-behavioral treatment for posttraumatic nightmares: An investigation of predictors of dropout and outcome. Psychological trauma : theory, research, practice and policy. 2013 Nov 1; 5(6):545-553.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Imagery Rehearsal and Sleep and Nightmare Management in people with Post-traumatic Stress Disorder, 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 5 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 18 Feb 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 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?
Yes. Results are posted in the registry (first posted 18 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Weekly Number of Nightmares (time frame: Baseline and 1, 3, and 6 months post-treatment). The study lists 3 primary outcomes in all. 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 NCT00108628, which also lists 3 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 18 Feb 2015.