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

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ClinicalTrials.gov Identifier: NCT02773693
Recruitment Status : Unknown
Verified September 2018 by University of North Texas, Denton, TX.
Recruitment status was:  Active, not recruiting
First Posted : May 16, 2016
Last Update Posted : September 27, 2018
Sponsor:
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.
Information provided by (Responsible Party):
University of North Texas, Denton, TX

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.

Condition or disease Intervention/treatment Phase
Trauma Insomnia Nightmares Behavioral: Cognitive Processing Therapy-Cognitive Only (CPT) Behavioral: Cognitive Behavioral Therapy of Insomnia and Nightmares (CBTin) Behavioral: Continuation Cognitive Processing Therapy-Cognitive Only (CPT) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Treatment of Comorbid Sleep Disorders and Post Traumatic Stress Disorder (PTSD)
Study Start Date : August 2016
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: CPT
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.
Behavioral: Cognitive Processing Therapy-Cognitive Only (CPT)
Twice weekly CPT over 6 weeks.

Behavioral: Continuation Cognitive Processing Therapy-Cognitive Only (CPT)
Once weekly continuation CPT over 6 weeks.

Active Comparator: CBTin+CPT
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.
Behavioral: Cognitive Processing Therapy-Cognitive Only (CPT)
Twice weekly CPT over 6 weeks.

Behavioral: Cognitive Behavioral Therapy of Insomnia and Nightmares (CBTin)
Cognitive behavioral therapy of insomnia and nightmares weekly over 6 weeks.

Active Comparator: CPT+CBTin
12 twice-weekly sessions of CPT followed by 6 sessions of CBTin.
Behavioral: Cognitive Processing Therapy-Cognitive Only (CPT)
Twice weekly CPT over 6 weeks.

Behavioral: Cognitive Behavioral Therapy of Insomnia and Nightmares (CBTin)
Cognitive behavioral therapy of insomnia and nightmares weekly over 6 weeks.




Primary Outcome Measures :
  1. Clinician Administered PTSD Scale (CAPS-5) [ 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). ]
    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 :
  1. PTSD Checklist -DSM-5 (PCL-5) [ 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). ]
    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.

  2. Sleep Diary Sleep Efficiency [ 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). ]
    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.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02773693


Locations
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United States, Texas
Carl R. Darnall Army Medical Center
Fort Hood, Texas, United States, 76544
Sponsors and Collaborators
University of North Texas, Denton, TX
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.
Investigators
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Principal Investigator: Daniel J Taylor, Ph.D. University of North Texas Health Science Center
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Responsible Party: University of North Texas, Denton, TX
ClinicalTrials.gov Identifier: NCT02773693    
Other Study ID Numbers: W81XWH-13-2-0065
1 I01 CX001136-01 ( Other Grant/Funding Number: Veterans Affairs )
First Posted: May 16, 2016    Key Record Dates
Last Update Posted: September 27, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Sleep Wake Disorders
Parasomnias
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Nervous System Diseases
Mental Disorders
Trauma and Stressor Related Disorders
Neurologic Manifestations