PTSDNAPNCT05120674
The Nightmare Augmented Protocol for Treatment of Nightmares in Veterans With PTSD
A study testing NAP, CPT and ERRT in people with PTSD, run by VA Eastern Kansas at 1 site in United States.
Trial summary
The primary goal of this study is to determine whether the use of a timed tone played during sleep, in addition to the use of established therapies, will reduce or eliminate the occurrence of nightmares. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- PTSD
- What is being tested?
- NAP, CPT and ERRT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2018to 27 May 2021
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veterans enrolled in the inpatient stress unit.
- Veterans who consent to participating in the treatment study.
- Veterans who report experiencing weekly nightmares related to a traumatic event.
Who cannot join
- Does not own a smartphone that can access the internet.
- Veterans who do not experience nightmares related to a traumatic event.
- Veterans who are unable to wear an electronic headband during sleep.
Trial locations and contacts
1 site in 1 country.
About this study
The primary goal of this study is to determine whether the use of a timed tone played during sleep, in addition to the use of established therapies, will reduce or eliminate the occurrence of nightmares. In particular, the protocol tests two different mechanisms for improvement: 1) further decreasing autonomic arousal and providing a mechanism for restoration and 2) enhancing memory processing for the alternate version of the traumatic events.
Read the detailed description
Study Population: The study population consisted of veterans who experienced nightmares and were enrolled in a voluntary inpatient stress unit at the Topeka VA. Given that individuals enrolled in the inpatient unit were under constant treatment conditions, there are no specific demographic requirements for this study.
Participants were informed about the study and, if interested, completed the informed consent process. Consented participants were randomly assigned to a treatment group. Self-reported symptoms (e.g., sleep duration, quality, presence and severity of nightmares) were assessed every morning via sleep diaries and sleep was recorded objectively via the DREEM device. Participants were debriefed upon completion of treatment.
All participants who consent for participation and meet inclusion/exclusion criteria were randomly assigned into one of three potential groups. Participants were randomly sorted into groups via an ordered systematic separation pattern. Both participants and data analysts were blinded to the group assignments. Specific protocol details for each group are described below. Regardless of group assignment, all participants followed the treatment unit's standard protocols, with the only change being that Groups 2 (Cognitive Processing Therapy + Cognitive Behavioral Therapy for Insomnia) \& 3 (Cognitive Processing Therapy + Cognitive Behavioral Therapy for Insomnia + Nightmare Augmented Protocol-NAP) participated in an Exposure, Relaxation, and Rescripting Therapy (ERRT) and Group 1 (Cognitive Processing Therapy only group) did not.
The NAP intervention: Veterans in group 3 completed the Cognitive Processing Therapy +ERRT protocol augmented by the auditory stimulation delivered by the DREEM device. Auditory stimulation consists of exposure and sleep stimulation. Exposure stimulation includes playing a rhythmic tone at 40-60hz (commonly referred to as pink noise) throughout the ERRT session and during the presleep exposure portion of ERRT. During the ERRT session, the tone will be played softly so as not to interfere with the session and will be played throughout the entire session. Before sleep, the veteran played the 40-60hz tone via their smartphone while they read their rescripted nightmare. During sleep, the 40-60hz tone was delivered during slow-wave-sleep (SWS) by the DREEM device. The DREEM device is a headband like device used to measure and enhance sleep via auditory stimulation. The DREEM device uses electroencephalogram (EEG) to determine when an individual is in SWS and then uses built in speakers to play the desired tone (this tone is undetectable to the dreamer and will not wake them). The DREEM device has been demonstrated to be a safe and effective device for measuring and enhancing sleep.
Data Collection: Presleep arousal, sleep quality, and the occurrence of a posttrauma nightmare(s) were assessed via sleep diaries. Sleep diaries were completed every night prior to bedtime and every morning upon awakening. Each daily diary consisted of outcome measures including the Nightmare Diary entry, Presleep Arousal Scale (PAS), Morning Diary entry, Pittsburgh Sleep Quality Index (PSQI), and the Trauma-Related Nightmare Survey (TRNS).
Statistical Analyses: Repeated measures Analysis of Variance (ANOVA) will be used to compare nightmare frequency and sleep quality both within and between treatment groups. These analyses will be used to determine if groups had significant reductions in nightmare frequency/ improvements in sleep quality improvement and to determine if there are group differences in sleep quality. For participants in the NAP group, the researchers will use multilevel modeling (MLM) to determine whether there were changes in sleep macro or micro architecture concurrent with introduction of the auditory tone.
- Conditions
- PTSD
- Being tested
- NAP, CPT, ERRT, Cognitive Behavioral Therapy for Insomnia
- 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.
NAPBehavioural
During the ERRT session, the tone will be played softly so as not to interfere with the session and will be played throughout the entire session. Before sleep, the veteran will play the 40-60hz tone via their smartphone while they read their rescripted nightmare. During sleep, the 40-60hz tone will be delivered during slow-wave-sleep (SWS) by the DREEM device. The pairing of the tone with the intervention is expected to trigger benefits of the exercise in reducing nightmare disturbance during sleep.
CPTBehavioural
Also called Cognitive Processing Therapy
Cognitive Therapy for PTSD
ERRTBehavioural
Also called Exposure, Relaxation, and Rescripting Therapy
ERRT asks individuals to rewrite the traumatic event that triggered their nightmares and then review the rescription before bed. This technique has been proven to drastically reduce the frequency of chronic nightmares.
Cognitive Behavioral Therapy for InsomniaBehavioural
Also called CBT-I
Cognitive Behavioral Therapy for Insomnia that includes behavioral and cognitive interventions related to sleep hygiene, increasing sleep drive, and modifying behaviors that result in association between laying in bed and wakeful states.
| Study group | Role | What they receive |
|---|---|---|
| CPT+CBT-I (usual care) | Active comparator | Veterans in this group completed the inpatient unit's existing Cognitive Processing Therapy (CPT) group based protocol. Furthermore, veterans in this group will also complete the inpatient unit's existing Cognitive Behavioral Therapy for Insomnia (CBT-I) group based protocol. Receives: Behavioral: CPT; Behavioral: Cognitive Behavioral Therapy for Insomnia |
| CPT+ CBT-I + ERRT | Active comparator | Veterans in this group completed the CPT and CBT-I protocols augmented by the ERRT. ERRT therapy focuses on treating the posttrauma nightmares and does these via sleep hygiene, nightmare rescription, and exposure. Receives: Behavioral: CPT; Behavioral: ERRT; Behavioral: Cognitive Behavioral Therapy for Insomnia |
| CPT+ CBT-I + ERRT + NAP | Experimental | Veterans in this group will complete the CPT+CBT-I+ERRT protocol augmented by auditory stimulation (NAP). Exposure stimulation includes playing a rhythmic tone at 40-60hz (commonly referred to as pink noise) throughout the ERRT session and during the presleep exposure portion of ERRT. During the ERRT session, the tone will be played softly so as not to interfere with the session and will be played throughout the entire session. Before sleep, the veteran will play the 40-60hz tone via their smartphone while they read their rescripted nightmare. During sleep, the 40-60hz tone will be delivered during slow-wave-sleep (SWS) by the DREEM device (DREEM, 2013). Receives: Behavioral: NAP; Behavioral: CPT; Behavioral: ERRT; Behavioral: Cognitive Behavioral Therapy for Insomnia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh Sleep Quality Index (PSQI)
The PSQI is a self-report measure designed to assess certain qualities and problems associated with sleep. Participants rate quality of sleep and degree of sleep difficulties for the month preceding the assessment. A global sleep quality score is obtained by summing the seven component scores including: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Higher scores reflect poorer sleep quality. The global score ranges from 0-21. A cut-off score of 5 as distinguishing "good" sleepers from "poor" sleepers with a diagnostic sensitivity of 89.6% and specificity of 86.5%. The PSQI was adapted for daily usage following standard protocols.
Measured: through study completion, an average of 1 month
Trauma-Related Nightmare Survey (TRNS)
The TRNS is a self-report measure developed for the assessment of nightmares and related sleep disturbance. The TRNS was adapted for daily usage following standard protocols.
Measured: through study completion, an average of 1 month
Secondary outcomes (1)
Presleep Arousal Scale (PAS)
The PAS is a self-report measure designed to assess somatic and cognitive arousal prior to sleep. Furthermore, the PAS can be combined to assess overall presleep arousal. The PAS has been found to be a reliable and valid measure of arousal. Cronbach's αs of the Cognitive and Somatic subscales were, respectively, 0.88 and 0.79. Furthermore, all item-subscale correlations are highly significant and in the predicted direction (all rs significant at p < 0.01). The PAS was updated for daily use.
Measured: through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start7 Aug 2018
- Primary completion27 May 2021
- Study completion27 May 2021
Why it stopped: Study interrupted due to COVID-19 and then investigator changed institutions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies 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
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Eastern Kansas
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Christi M. Houston, PsyD, VA Eastern Kansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05120674
- Sponsor's protocol ID
- CH-0001
- Acronym
- NAP
- Status last verified
- Oct 2021
- First submitted
- 5 Oct 2021
- Last updated
- 15 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Nightmare Augmented Protocol for Treatment of Nightmares in Veterans With PTSD
- ClinicalTrials.gov ID
- NCT05120674
- Acronym / sponsor ID
- NAP / CH-0001
- Conditions
- PTSD
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study interrupted due to COVID-19 and then investigator changed institutions
- Enrolment
- 28 participants (actual)
- Lead sponsor
- VA Eastern KansasUS federal agency
- Study start
- 7 Aug 2018 (actual)
- Primary completion
- 27 May 2021 (actual)
- Study completion
- 27 May 2021 (actual)
- First posted
- 15 Nov 2021 (actual)
- 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 primary goal of this study is to determine whether the use of a timed tone played during sleep, in addition to the use of established therapies, will reduce or eliminate the occurrence of nightmares. In particular, the protocol tests two different mechanisms for improvement: 1) further decreasing autonomic arousal and providing a mechanism for restoration and 2) enhancing memory processing for the alternate version of the traumatic events.
Detailed description
Study Population: The study population consisted of veterans who experienced nightmares and were enrolled in a voluntary inpatient stress unit at the Topeka VA. Given that individuals enrolled in the inpatient unit were under constant treatment conditions, there are no specific demographic requirements for this study.
Participants were informed about the study and, if interested, completed the informed consent process. Consented participants were randomly assigned to a treatment group. Self-reported symptoms (e.g., sleep duration, quality, presence and severity of nightmares) were assessed every morning via sleep diaries and sleep was recorded objectively via the DREEM device. Participants were debriefed upon completion of treatment.
All participants who consent for participation and meet inclusion/exclusion criteria were randomly assigned into one of three potential groups. Participants were randomly sorted into groups via an ordered systematic separation pattern. Both participants and data analysts were blinded to the group assignments. Specific protocol details for each group are described below. Regardless of group assignment, all participants followed the treatment unit's standard protocols, with the only change being that Groups 2 (Cognitive Processing Therapy + Cognitive Behavioral Therapy for Insomnia) \& 3 (Cognitive Processing Therapy + Cognitive Behavioral Therapy for Insomnia + Nightmare Augmented Protocol-NAP) participated in an Exposure, Relaxation, and Rescripting Therapy (ERRT) and Group 1 (Cognitive Processing Therapy only group) did not.
The NAP intervention: Veterans in group 3 completed the Cognitive Processing Therapy +ERRT protocol augmented by the auditory stimulation delivered by the DREEM device. Auditory stimulation consists of exposure and sleep stimulation. Exposure stimulation includes playing a rhythmic tone at 40-60hz (commonly referred to as pink noise) throughout the ERRT session and during the presleep exposure portion of ERRT. During the ERRT session, the tone will be played softly so as not to interfere with the session and will be played throughout the entire session. Before sleep, the veteran played the 40-60hz tone via their smartphone while they read their rescripted nightmare. During sleep, the 40-60hz tone was delivered during slow-wave-sleep (SWS) by the DREEM device. The DREEM device is a headband like device used to measure and enhance sleep via auditory stimulation. The DREEM device uses electroencephalogram (EEG) to determine when an individual is in SWS and then uses built in speakers to play the desired tone (this tone is undetectable to the dreamer and will not wake them). The DREEM device has been demonstrated to be a safe and effective device for measuring and enhancing sleep.
Data Collection: Presleep arousal, sleep quality, and the occurrence of a posttrauma nightmare(s) were assessed via sleep diaries. Sleep diaries were completed every night prior to bedtime and every morning upon awakening. Each daily diary consisted of outcome measures including the Nightmare Diary entry, Presleep Arousal Scale (PAS), Morning Diary entry, Pittsburgh Sleep Quality Index (PSQI), and the Trauma-Related Nightmare Survey (TRNS).
Statistical Analyses: Repeated measures Analysis of Variance (ANOVA) will be used to compare nightmare frequency and sleep quality both within and between treatment groups. These analyses will be used to determine if groups had significant reductions in nightmare frequency/ improvements in sleep quality improvement and to determine if there are group differences in sleep quality. For participants in the NAP group, the researchers will use multilevel modeling (MLM) to determine whether there were changes in sleep macro or micro architecture concurrent with introduction of the auditory tone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CPT+CBT-I (usual care) | Active comparator | Behavioral: CPT, Behavioral: Cognitive Behavioral Therapy for InsomniaVeterans in this group completed the inpatient unit's existing Cognitive Processing Therapy (CPT) group based protocol. Furthermore, veterans in this group will also complete the inpatient unit's existing Cognitive Behavioral Therapy for Insomnia (CBT-I) group based protocol. |
| CPT+ CBT-I + ERRT | Active comparator | Behavioral: CPT, Behavioral: ERRT, Behavioral: Cognitive Behavioral Therapy for InsomniaVeterans in this group completed the CPT and CBT-I protocols augmented by the ERRT. ERRT therapy focuses on treating the posttrauma nightmares and does these via sleep hygiene, nightmare rescription, and exposure. |
| CPT+ CBT-I + ERRT + NAP | Experimental | Behavioral: NAP, Behavioral: CPT, Behavioral: ERRT, Behavioral: Cognitive Behavioral Therapy for InsomniaVeterans in this group will complete the CPT+CBT-I+ERRT protocol augmented by auditory stimulation (NAP). Exposure stimulation includes playing a rhythmic tone at 40-60hz (commonly referred to as pink noise) throughout the ERRT session and during the presleep exposure portion of ERRT. During the ERRT session, the tone will be played softly so as not to interfere with the session and will be played throughout the entire session. Before sleep, the veteran will play the 40-60hz tone via their smartphone while they read their rescripted nightmare. During sleep, the 40-60hz tone will be delivered during slow-wave-sleep (SWS) by the DREEM device (DREEM, 2013). |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Veterans enrolled in the inpatient stress unit.
- Veterans who consent to participating in the treatment study.
- Veterans who report experiencing weekly nightmares related to a traumatic event.
Key exclusion criteria (3 listed)
- Does not own a smartphone that can access the internet.
- Veterans who do not experience nightmares related to a traumatic event.
- Veterans who are unable to wear an electronic headband during 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 |
|---|---|---|
| NAPDuring the ERRT session, the tone will be played softly so as not to interfere with the session and will be played throughout the entire session. Before sleep, the veteran will play the 40-60hz tone via their smartphone while they read their rescripted nightmare. During sleep, the 40-60hz tone will be delivered during slow-wave-sleep (SWS) by the DREEM device. The pairing of the tone with the intervention is expected to trigger benefits of the exercise in reducing nightmare disturbance during sleep. | Behavioural | CPT+ CBT-I + ERRT + NAP |
| CPTAlso: Cognitive Processing TherapyCognitive Therapy for PTSD | Behavioural | CPT+ CBT-I + ERRT, CPT+ CBT-I + ERRT + NAP, CPT+CBT-I (usual care) |
| ERRTAlso: Exposure, Relaxation, and Rescripting TherapyERRT asks individuals to rewrite the traumatic event that triggered their nightmares and then review the rescription before bed. This technique has been proven to drastically reduce the frequency of chronic nightmares. | Behavioural | CPT+ CBT-I + ERRT, CPT+ CBT-I + ERRT + NAP |
| Cognitive Behavioral Therapy for InsomniaAlso: CBT-ICognitive Behavioral Therapy for Insomnia that includes behavioral and cognitive interventions related to sleep hygiene, increasing sleep drive, and modifying behaviors that result in association between laying in bed and wakeful states. | Behavioural | CPT+ CBT-I + ERRT, CPT+ CBT-I + ERRT + NAP, CPT+CBT-I (usual care) |
Primary outcome
Pittsburgh Sleep Quality Index (PSQI)
Time frame: through study completion, an average of 1 month
The PSQI is a self-report measure designed to assess certain qualities and problems associated with sleep. Participants rate quality of sleep and degree of sleep difficulties for the month preceding the assessment. A global sleep quality score is obtained by summing the seven component scores including: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Higher scores reflect poorer sleep quality. The global score ranges from 0-21. A cut-off score of 5 as distinguishing "good" sleepers from "poor" sleepers with a diagnostic sensitivity of 89.6% and specificity of 86.5%. The PSQI was adapted for daily usage following standard protocols.
Trauma-Related Nightmare Survey (TRNS)
Time frame: through study completion, an average of 1 month
The TRNS is a self-report measure developed for the assessment of nightmares and related sleep disturbance. The TRNS was adapted for daily usage following standard protocols.
1 secondary outcome
Presleep Arousal Scale (PAS)
Time frame: through study completion, an average of 1 month
Results and safety
The study was stopped early (reason given: Study interrupted due to COVID-19 and then investigator changed institutions). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2021.
- 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.
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 NAP, CPT and ERRT in people with PTSD, run by VA Eastern Kansas 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 3 inclusion and 3 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 15 Nov 2021. 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: Study interrupted due to COVID-19 and then investigator changed institutions). 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?
Pittsburgh Sleep Quality Index (PSQI) (time frame: through study completion, an average of 1 month). The study lists 2 primary outcomes in all. 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 15 Nov 2021.