The Nightmare Augmented Protocol for Treatment of Nightmares in Veterans With PTSD
NCT ID: NCT05120674
Last Updated: 2021-11-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
28 participants
INTERVENTIONAL
2018-08-07
2021-05-27
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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CPT+CBT-I (usual care)
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.
CPT
Cognitive Therapy for PTSD
Cognitive Behavioral Therapy for Insomnia
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.
CPT+ CBT-I + ERRT
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.
CPT
Cognitive Therapy for PTSD
ERRT
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 Insomnia
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.
CPT+ CBT-I + ERRT + NAP
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).
NAP
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.
CPT
Cognitive Therapy for PTSD
ERRT
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 Insomnia
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.
Interventions
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NAP
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.
CPT
Cognitive Therapy for PTSD
ERRT
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 Insomnia
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Veterans who consent to participating in the treatment study.
3. Veterans who report experiencing weekly nightmares related to a traumatic event.
Exclusion Criteria
2. Veterans who do not experience nightmares related to a traumatic event.
3. Veterans who are unable to wear an electronic headband during sleep.
18 Years
99 Years
ALL
No
Sponsors
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VA Eastern Kansas
FED
Responsible Party
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Christi M. Houston, PsyD
Principal Investigator
Locations
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VA Eastern Kansas
Leavenworth, Kansas, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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CH-0001
Identifier Type: -
Identifier Source: org_study_id