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Treatment of Comorbid Sleep Disorders and Post Traumatic Stress Disorder (PTSD)

Primary Purpose

Trauma, Insomnia, Nightmares

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Processing Therapy-Cognitive Only (CPT)
Cognitive Behavioral Therapy of Insomnia and Nightmares (CBTin)
Continuation Cognitive Processing Therapy-Cognitive Only (CPT)
Sponsored by
University of North Texas, Denton, TX
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trauma

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Aged 18-50.
  • Chronic Insomnia, as defined by the Diagnostic and Statistical Manual-fifth edition (DSM-5) (American Psychiatric Association, 2013) assessed with Structured Clinical Interview for DSM-5 Sleep Disorders (SCISD).
  • Chronic Nightmare Disorder, as defined by DSM-5, assessed with the SCISD.
  • PTSD, as defined by DSM-5, assessed by Clinician-Administered Posttraumatic Stress Scale-5 (CAPS-5).
  • Active duty military and recently discharged Veterans at Fort Hood eligible for treatment at Carl R. Darnall Army Medical Center (CRDAMC).
  • History of having deployed in support of combat operations following 9/11, assessed by self-report.
  • Stable on psychotropic and/or hypnotic medications and/or interventions for sleep (e.g., Continuous Positive Air Pressure for sleep apnea) administered by other providers for at least one month assessed by self-report and review of medical record.
  • Willing to refrain from new behavioral health or medication treatment for issues pertaining to sleep, PTSD, or nightmares during participation in the study.
  • Indication that the individual plans to be in the area for the 5 months following the first assessment.

Exclusion Criteria:

  • Individuals who have been re-deployed from a theater of operation less than 3 months.
  • Current suicide or homicide risk meriting crisis intervention as assessed by the Patient Health Questionnaire (PHQ-9), The Depressive Symptom Index - Suicidality Subscale (DSI-SS), or the Self-Injurious Thoughts and Behaviors Interview (SITBI).
  • Inability to speak and read English.
  • Moderate to severe brain damage, assessed by the inability to comprehend the baseline questionnaires.
  • Pregnancy, assessed by self-report and review of medical record, because sleep disturbances due to pregnancy may be the result of different mechanisms and the proposed instruments and treatments have not been validated in this population.
  • Current circadian rhythm, environmental, sleep deprivation, or hypersomnia sleep disorder, assessed by self-report because CBTin has not been validated in these populations.
  • Other untreated sleep disorders to include individuals with clinically significant obstructive sleep apnea (Respiratory Disturbance Index >5/hr), periodic limb movement disorder (PLMD; >15/hr with arousals), nocturnal seizures, or a parasomnia (e.g., sleepwalking, confusional arousals, nocturnal eating and drinking syndrome), based on criteria from the International Classification of Sleep Disorders-third edition (American Academy of Sleep Medicine, 2013). Individuals meeting criteria for one of the above sleep disorders will be seen for clinical care at the CRDAMC Sleep Center. Once the aforementioned sleep disorder is stably treated, individuals meeting the study criteria for insomnia, nightmares, and PTSD can be reassessed for participation in this study.
  • Sleep efficiency >85%, as assessed by the sleep diary.
  • Serious mental health diagnosis (e.g., bipolar disorder or psychosis) assessed with review of baseline questionnaires, review of medical record, and/or Mini International Neuropsychiatric Interview (MINI 7.0 Mania module).
  • Currently engaged in evidence-based psychotherapy for PTSD (i.e., Prolonged Exposure Therapy or Cognitive Processing Therapy) or Insomnia or nightmares (i.e., Cognitive Behavioral Therapy) by self-report and review of medical record.

Sites / Locations

  • Carl R. Darnall Army Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

CPT

CBTin+CPT

CPT+CBTin

Arm Description

Cognitive Processing Therapy-cognitive only version (typically labeled CPT-C, but labeled CPT in this grant for simplicity) is a type of Cognitive Therapy addressing daytime symptoms of PTSD. This arm will have 12 twice-weekly sessions, followed by 6 weekly sessions.

Cognitive Behavioral Therapy of Insomnia and nightmares (CBTin) will be used to address nighttime symptoms of PTSD during 6 weekly sessions, followed by 12 twice-weekly sessions of CPT.

12 twice-weekly sessions of CPT followed by 6 sessions of CBTin.

Outcomes

Primary Outcome Measures

Clinician Administered PTSD Scale (CAPS-5)
The CAPS-5 (Weathers, Litz, et al., 2013) is a structured diagnostic interview and gold standard for assessing PTSD. The scale also assesses social and occupational functioning, dissociation, and the validity of symptom reports. The CAPS was revised to match DSM-5. The CAPS was revised to accommodate the changes made in DSM-5, to reduce administration time, and to facilitate learning administration and scoring procedures. The CAPS-5 will be the primary outcome of PTSD symptom severity.

Secondary Outcome Measures

PTSD Checklist -DSM-5 (PCL-5)
The PCL-5 (Weathers, Blake, et al., 2013) is a 20-item self-report measure designed to assess PSTSD symptoms as defined by the DSM-5. The PCL-5 will be the secondary outcome of PTSD symptom severity.
Sleep Diary Sleep Efficiency
Sleep diaries will be used for seven days to measure subjective sleep patterns (Carney et al., 2012). Participants will be asked to make daily diary entries with an estimate of their sleep the night before (e.g., bedtime, sleep onset). Questions will also assess nightmare frequency and severity. Average sleep efficiency ((total sleep time/time in bed) x 100) derived from the sleep diaries will be the primary outcome of insomnia symptom severity.

Full Information

First Posted
May 9, 2016
Last Updated
September 26, 2018
Sponsor
University of North Texas, Denton, TX
Collaborators
The University of Texas Health Science Center at San Antonio, South Texas Veterans Health Care System, Duke University, Durham VA Medical Center, Boston VA Research Institute, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02773693
Brief Title
Treatment of Comorbid Sleep Disorders and Post Traumatic Stress Disorder (PTSD)
Official Title
Treatment of Comorbid Sleep Disorders and Post Traumatic Stress Disorder (PTSD)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
September 2019 (Anticipated)
Study Completion Date
September 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Texas, Denton, TX
Collaborators
The University of Texas Health Science Center at San Antonio, South Texas Veterans Health Care System, Duke University, Durham VA Medical Center, Boston VA Research Institute, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective of the current study is to determine if providing cognitive-behavioral therapy of Insomnia and nightmares (CBTin) and Cognitive Processing Therapy of PTSD (CPT) results in greater PTSD and sleep symptom reduction than CPT only. A secondary objective is to determine if the sequencing of CBTl&N before or after CPT results in differential effects on PTSD and sleep symptom reduction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma, Insomnia, Nightmares

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CPT
Arm Type
Active Comparator
Arm Description
Cognitive Processing Therapy-cognitive only version (typically labeled CPT-C, but labeled CPT in this grant for simplicity) is a type of Cognitive Therapy addressing daytime symptoms of PTSD. This arm will have 12 twice-weekly sessions, followed by 6 weekly sessions.
Arm Title
CBTin+CPT
Arm Type
Active Comparator
Arm Description
Cognitive Behavioral Therapy of Insomnia and nightmares (CBTin) will be used to address nighttime symptoms of PTSD during 6 weekly sessions, followed by 12 twice-weekly sessions of CPT.
Arm Title
CPT+CBTin
Arm Type
Active Comparator
Arm Description
12 twice-weekly sessions of CPT followed by 6 sessions of CBTin.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Processing Therapy-Cognitive Only (CPT)
Intervention Description
Twice weekly CPT over 6 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy of Insomnia and Nightmares (CBTin)
Intervention Description
Cognitive behavioral therapy of insomnia and nightmares weekly over 6 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Continuation Cognitive Processing Therapy-Cognitive Only (CPT)
Intervention Description
Once weekly continuation CPT over 6 weeks.
Primary Outcome Measure Information:
Title
Clinician Administered PTSD Scale (CAPS-5)
Description
The CAPS-5 (Weathers, Litz, et al., 2013) is a structured diagnostic interview and gold standard for assessing PTSD. The scale also assesses social and occupational functioning, dissociation, and the validity of symptom reports. The CAPS was revised to match DSM-5. The CAPS was revised to accommodate the changes made in DSM-5, to reduce administration time, and to facilitate learning administration and scoring procedures. The CAPS-5 will be the primary outcome of PTSD symptom severity.
Time Frame
Change from baseline to 1-month post-treatment (i.e., after the completion of all 18 sessions, not to exceed 22 weeks from baseline).
Secondary Outcome Measure Information:
Title
PTSD Checklist -DSM-5 (PCL-5)
Description
The PCL-5 (Weathers, Blake, et al., 2013) is a 20-item self-report measure designed to assess PSTSD symptoms as defined by the DSM-5. The PCL-5 will be the secondary outcome of PTSD symptom severity.
Time Frame
Change from baseline to 1-month post-treatment (i.e., after the completion of all 18 sessions, not to exceed 22 weeks from baseline).
Title
Sleep Diary Sleep Efficiency
Description
Sleep diaries will be used for seven days to measure subjective sleep patterns (Carney et al., 2012). Participants will be asked to make daily diary entries with an estimate of their sleep the night before (e.g., bedtime, sleep onset). Questions will also assess nightmare frequency and severity. Average sleep efficiency ((total sleep time/time in bed) x 100) derived from the sleep diaries will be the primary outcome of insomnia symptom severity.
Time Frame
Change from baseline to 1-month post-treatment (i.e., after the completion of all 18 sessions, not to exceed 22 weeks from baseline).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Aged 18-50. Chronic Insomnia, as defined by the Diagnostic and Statistical Manual-fifth edition (DSM-5) (American Psychiatric Association, 2013) assessed with Structured Clinical Interview for DSM-5 Sleep Disorders (SCISD). Chronic Nightmare Disorder, as defined by DSM-5, assessed with the SCISD. PTSD, as defined by DSM-5, assessed by Clinician-Administered Posttraumatic Stress Scale-5 (CAPS-5). Active duty military and recently discharged Veterans at Fort Hood eligible for treatment at Carl R. Darnall Army Medical Center (CRDAMC). History of having deployed in support of combat operations following 9/11, assessed by self-report. Stable on psychotropic and/or hypnotic medications and/or interventions for sleep (e.g., Continuous Positive Air Pressure for sleep apnea) administered by other providers for at least one month assessed by self-report and review of medical record. Willing to refrain from new behavioral health or medication treatment for issues pertaining to sleep, PTSD, or nightmares during participation in the study. Indication that the individual plans to be in the area for the 5 months following the first assessment. Exclusion Criteria: Individuals who have been re-deployed from a theater of operation less than 3 months. Current suicide or homicide risk meriting crisis intervention as assessed by the Patient Health Questionnaire (PHQ-9), The Depressive Symptom Index - Suicidality Subscale (DSI-SS), or the Self-Injurious Thoughts and Behaviors Interview (SITBI). Inability to speak and read English. Moderate to severe brain damage, assessed by the inability to comprehend the baseline questionnaires. Pregnancy, assessed by self-report and review of medical record, because sleep disturbances due to pregnancy may be the result of different mechanisms and the proposed instruments and treatments have not been validated in this population. Current circadian rhythm, environmental, sleep deprivation, or hypersomnia sleep disorder, assessed by self-report because CBTin has not been validated in these populations. Other untreated sleep disorders to include individuals with clinically significant obstructive sleep apnea (Respiratory Disturbance Index >5/hr), periodic limb movement disorder (PLMD; >15/hr with arousals), nocturnal seizures, or a parasomnia (e.g., sleepwalking, confusional arousals, nocturnal eating and drinking syndrome), based on criteria from the International Classification of Sleep Disorders-third edition (American Academy of Sleep Medicine, 2013). Individuals meeting criteria for one of the above sleep disorders will be seen for clinical care at the CRDAMC Sleep Center. Once the aforementioned sleep disorder is stably treated, individuals meeting the study criteria for insomnia, nightmares, and PTSD can be reassessed for participation in this study. Sleep efficiency >85%, as assessed by the sleep diary. Serious mental health diagnosis (e.g., bipolar disorder or psychosis) assessed with review of baseline questionnaires, review of medical record, and/or Mini International Neuropsychiatric Interview (MINI 7.0 Mania module). Currently engaged in evidence-based psychotherapy for PTSD (i.e., Prolonged Exposure Therapy or Cognitive Processing Therapy) or Insomnia or nightmares (i.e., Cognitive Behavioral Therapy) by self-report and review of medical record.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel J Taylor, Ph.D.
Organizational Affiliation
University of North Texas Health Science Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carl R. Darnall Army Medical Center
City
Fort Hood
State/Province
Texas
ZIP/Postal Code
76544
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35197191
Citation
Miles SR, Pruiksma KE, Slavish D, Dietch JR, Wardle-Pinkston S, Litz BT, Rodgers M, Nicholson KL, Young-McCaughan S, Dondanville KA, Nakase-Richardson R, Mintz J, Keane TM, Peterson AL, Resick PA, Taylor DJ; Consortium to Alleviate PTSD. Sleep disorder symptoms are associated with greater posttraumatic stress and anger symptoms in US Army service members seeking treatment for posttraumatic stress disorder. J Clin Sleep Med. 2022 Jun 1;18(6):1617-1627. doi: 10.5664/jcsm.9926.
Results Reference
derived

Learn more about this trial

Treatment of Comorbid Sleep Disorders and Post Traumatic Stress Disorder (PTSD)

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