NightmaresNCT01009112
Treating Insomnia & Nightmares After Trauma: Impact on Symptoms & Quality of Life
A study testing PTSD + IRT/CBT-I and PTSD + Supportive Care Therapy in people with Nightmares and Insomnia, run by University of California, San Diego at 1 site in United States.
Trial summary
Exposure to trauma, especially when it manifests as Posttraumatic Stress Disorder (PTSD), results in numerous negative consequences for patients, families, and society. Some of the most frequent, disturbing, and treatment resistant symptoms of PTSD are nightmares and insomnia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nightmares, Insomnia, Posttraumatic Stress Disorder
- What is being tested?
- PTSD + IRT/CBT-I and PTSD + Supportive Care Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Nov 2012
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1 or more deployments to OEF or OIF
- Exposure to Trauma
- Nightmares 2 or more times per week
- Insomnia for 1 month or more
- Live in greater San Diego County region
Who cannot join
- Use of medications for sleep or nightmares in the past 2 weeks
- Current enrollment in psychotherapy for PTSD
- Current or recent substance or alcohol abuse or dependence
- Other untreated sleep disorders (e.g., sleep apnea)
Trial locations and contacts
1 site in 1 country.
United States1 site
Veterans Affairs San Diego Healthcare System
San Diego, California, 92161
About this study
Exposure to trauma, especially when it manifests as Posttraumatic Stress Disorder (PTSD), results in numerous negative consequences for patients, families, and society. Some of the most frequent, disturbing, and treatment resistant symptoms of PTSD are nightmares and insomnia. This study will examine whether treatments specifically targeted at those sleep disorders can improve clinical outcomes and increase health-related quality of life in individuals recently exposed to war-related trauma. Hypotheses are that treating nightmares and insomnia will improve both nighttime and daytime symptoms of PTSD, as well as quality of life.
- Conditions
- Nightmares, Insomnia, Posttraumatic Stress Disorder
- Being tested
- PTSD + IRT/CBT-I, PTSD + Supportive Care Therapy
- Keywords
- Sleep, Sleep Disorder, Veterans, Active Duty, OEF, OIF, PTSD
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, 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.
PTSD + IRT/CBT-IBehavioural
Also called IRT, PE, exposure therapy, Cognitive Behavioral Therapy for Insomnia
6 weeks of prolonged exposure, 5 weeks of imagery rehearsal therapy, and 7 weeks of cognitive behavioral therapy for insomnia
PTSD + Supportive Care TherapyBehavioural
Also called PE, exposure therapy
6 weeks of prolonged exposure + 12 weeks of supportive care therapy
| Study group | Role | What they receive |
|---|---|---|
| CBT for Insomnia | Experimental | Patients change their sleep times and habits in order to reduce alertness and "over thinking" when they are trying to sleep. This helps them learn how to sleep overnight in one solid block of time Receives: Behavioral: PTSD + IRT/CBT-I |
| Imagery Rehearsal Therapy | Experimental | Patients "rescript" the narrative of a nightmare to eliminate the distressing elements and create a new pleasant dream scene. They then rehearse this scene in their imagination at least twice each day. This reduces the frequency and intensity of the target nightmare and often reduces other nightmares, too. Receives: Behavioral: PTSD + IRT/CBT-I |
| Prolonged Exposure | Experimental | This behavioral treatment for PTSD involves 1) systematic and repeated exposure to objects and situations that are avoided due to trauma-related distress, 2) prolonged, repeated recounting of trauma memories through visualization, and 3)therapist-guided discussions of thoughts and emotions related to the exposure exercises. The goals of PE are to reduce the anxiety and distress elicited by trauma-related memories and situations, show patients these memories and situations are distinct from the trauma, and teach patients they can tolerate the distress caused by these memories and situations. Receives: Behavioral: PTSD + IRT/CBT-I; Behavioral: PTSD + Supportive Care Therapy |
| Suportive Care Therapy | Active comparator | This is an active therapy where the focus of the intervention is on helping patients better understand their emotional response to their PTSD and sleep symptoms. Receives: Behavioral: PTSD + Supportive Care Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
nightmares and insomnia symptoms
Measured: pre-treatment; weeks 6, 11, and 18 of treatment; 3-month follow-up post-treatment
Secondary outcomes (2)
daytime (non-sleep) PTSD symptoms
Measured: pre-treatment; weeks 6, 11, and 18 of treatment; 3-month follow-up post-treatment
health-related quality of life
Measured: pre-treatment; weeks 6, 11, and 18 of treatment; 3-month follow-up post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2009 (estimated)
- Study startJan 2010
- Primary completionAug 2012
- Study completionNov 2012
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 NightmaresStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Sean P.A. Drummond, University of California, San Diego
- Investigators
- Sean PA Drummond, PhD, Principal investigator, Veterans Medical Research Foundation & University of California San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01009112
- Sponsor's protocol ID
- 1RC1NR011728-01
- Status last verified
- May 2015
- First submitted
- 5 Nov 2009
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Mascaro L, Phillips AJK, Clark JW, Straus LD, Drummond SPA. Diurnal Rhythm Robustness in Individuals With PTSD and Insomnia and The Association With Sleep. J Biol Rhythms. 2021 Apr;36(2):185-195. doi: 10.1177/0748730420984563. Epub 2021 Jan 20.
PubMed 33472513Walters EM, Jenkins MM, Nappi CM, Clark J, Lies J, Norman SB, Drummond SPA. The impact of prolonged exposure on sleep and enhancing treatment outcomes with evidence-based sleep interventions: A pilot study. Psychol Trauma. 2020 Feb;12(2):175-185. doi: 10.1037/tra0000478. Epub 2019 Jun 27.
PubMed 31246050
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Insomnia & Nightmares After Trauma: Impact on Symptoms & Quality of Life
- ClinicalTrials.gov ID
- NCT01009112
- Acronym / sponsor ID
- 1RC1NR011728-01
- Conditions
- Nightmares, Insomnia, Posttraumatic Stress Disorder
- Keywords
- Sleep, Sleep Disorder, Veterans, Active Duty, OEF, OIF, PTSD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Nursing Research (NINR)
- Study start
- Jan 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 6 Nov 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.
Exposure to trauma, especially when it manifests as Posttraumatic Stress Disorder (PTSD), results in numerous negative consequences for patients, families, and society. Some of the most frequent, disturbing, and treatment resistant symptoms of PTSD are nightmares and insomnia. This study will examine whether treatments specifically targeted at those sleep disorders can improve clinical outcomes and increase health-related quality of life in individuals recently exposed to war-related trauma. Hypotheses are that treating nightmares and insomnia will improve both nighttime and daytime symptoms of PTSD, as well as quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CBT for Insomnia | Experimental | Behavioral: PTSD + IRT/CBT-IPatients change their sleep times and habits in order to reduce alertness and "over thinking" when they are trying to sleep. This helps them learn how to sleep overnight in one solid block of time |
| Imagery Rehearsal Therapy | Experimental | Behavioral: PTSD + IRT/CBT-IPatients "rescript" the narrative of a nightmare to eliminate the distressing elements and create a new pleasant dream scene. They then rehearse this scene in their imagination at least twice each day. This reduces the frequency and intensity of the target nightmare and often reduces other nightmares, too. |
| Prolonged Exposure | Experimental | Behavioral: PTSD + IRT/CBT-I, Behavioral: PTSD + Supportive Care TherapyThis behavioral treatment for PTSD involves 1) systematic and repeated exposure to objects and situations that are avoided due to trauma-related distress, 2) prolonged, repeated recounting of trauma memories through visualization, and 3)therapist-guided discussions of thoughts and emotions related to the exposure exercises. The goals of PE are to reduce the anxiety and distress elicited by trauma-related memories and situations, show patients these memories and situations are distinct from the trauma, and teach patients they can tolerate the distress caused by these memories and situations. |
| Suportive Care Therapy | Active comparator | Behavioral: PTSD + Supportive Care TherapyThis is an active therapy where the focus of the intervention is on helping patients better understand their emotional response to their PTSD and sleep symptoms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1 or more deployments to OEF or OIF
- Exposure to Trauma
- Nightmares 2 or more times per week
- Insomnia for 1 month or more
- Live in greater San Diego County region
Key exclusion criteria (4 listed)
- Use of medications for sleep or nightmares in the past 2 weeks
- Current enrollment in psychotherapy for PTSD
- Current or recent substance or alcohol abuse or dependence
- Other untreated sleep disorders (e.g., sleep apnea)
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 |
|---|---|---|
| PTSD + IRT/CBT-IAlso: IRT, PE, exposure therapy, Cognitive Behavioral Therapy for Insomnia6 weeks of prolonged exposure, 5 weeks of imagery rehearsal therapy, and 7 weeks of cognitive behavioral therapy for insomnia | Behavioural | CBT for Insomnia, Imagery Rehearsal Therapy, Prolonged Exposure |
| PTSD + Supportive Care TherapyAlso: PE, exposure therapy6 weeks of prolonged exposure + 12 weeks of supportive care therapy | Behavioural | Prolonged Exposure, Suportive Care Therapy |
Primary outcome
nightmares and insomnia symptoms
Time frame: pre-treatment; weeks 6, 11, and 18 of treatment; 3-month follow-up post-treatment
2 secondary outcomes
daytime (non-sleep) PTSD symptoms
Time frame: pre-treatment; weeks 6, 11, and 18 of treatment; 3-month follow-up post-treatment
health-related quality of life
Time frame: pre-treatment; weeks 6, 11, and 18 of treatment; 3-month follow-up post-treatment
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 28 May 2015.
- Derived from this study: PubMed 33472513Mascaro L, Phillips AJK, Clark JW, Straus LD, Drummond SPA. Diurnal Rhythm Robustness in Individuals With PTSD and Insomnia and The Association With Sleep. J Biol Rhythms. 2021 Apr;36(2):185-195. doi: 10.1177/0748730420984563. Epub 2021 Jan 20.
- Derived from this study: PubMed 31246050Walters EM, Jenkins MM, Nappi CM, Clark J, Lies J, Norman SB, Drummond SPA. The impact of prolonged exposure on sleep and enhancing treatment outcomes with evidence-based sleep interventions: A pilot study. Psychol Trauma. 2020 Feb;12(2):175-185. doi: 10.1037/tra0000478. Epub 2019 Jun 27.
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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.
Sean PA Drummond, PhD principal investigator
Veterans Medical Research Foundation & University of California San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PTSD + IRT/CBT-I and PTSD + Supportive Care Therapy in people with Nightmares and Insomnia, run by University of California, San Diego 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 28 May 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?
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?
nightmares and insomnia symptoms (time frame: pre-treatment; weeks 6, 11, and 18 of treatment; 3-month follow-up post-treatment). 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 NCT01009112, 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 28 May 2015.