NCT05120674

Brief 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. 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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 7, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 27, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 27, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 5, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 15, 2021

Completed
Last Updated

November 15, 2021

Status Verified

October 1, 2021

Enrollment Period

2.8 years

First QC Date

October 5, 2021

Last Update Submit

November 3, 2021

Conditions

PTSD

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    through study completion, an average of 1 month

Secondary Outcomes (1)

  • Presleep Arousal Scale (PAS)

    through study completion, an average of 1 month

Study Arms (3)

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.

Behavioral: CPTBehavioral: 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.

Behavioral: CPTBehavioral: ERRTBehavioral: 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).

Behavioral: NAPBehavioral: CPTBehavioral: ERRTBehavioral: Cognitive Behavioral Therapy for Insomnia

Interventions

NAPBEHAVIORAL

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+ CBT-I + ERRT + NAP
CPTBEHAVIORAL

Cognitive Therapy for PTSD

Also known as: Cognitive Processing Therapy
CPT+ CBT-I + ERRTCPT+ CBT-I + ERRT + NAPCPT+CBT-I (usual care)
ERRTBEHAVIORAL

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.

Also known as: Exposure, Relaxation, and Rescripting Therapy
CPT+ CBT-I + ERRTCPT+ CBT-I + ERRT + NAP
Cognitive Behavioral Therapy for InsomniaBEHAVIORAL

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.

Also known as: CBT-I
CPT+ CBT-I + ERRTCPT+ CBT-I + ERRT + NAPCPT+CBT-I (usual care)

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Eastern Kansas

Leavenworth, Kansas, 66048, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

2-cyclohexylidenhydrazo-4-phenyl-thiazoleCognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 5, 2021

First Posted

November 15, 2021

Study Start

August 7, 2018

Primary Completion

May 27, 2021

Study Completion

May 27, 2021

Last Updated

November 15, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)