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

September 26, 2018 updated by: University of North Texas, Denton, TX
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
94

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Fort Hood, Texas, United States, 76544
        • Carl R. Darnall Army Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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 Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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 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.
Change from baseline to 1-month post-treatment (i.e., after the completion of all 18 sessions, not to exceed 22 weeks from baseline).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of North Texas, Denton, TX

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Duke University
The University of Texas Health Science Center at San Antonio
Boston VA Research Institute, Inc.
Durham VA Medical Center
South Texas Veterans Health Care System

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Daniel J Taylor, Ph.D., University of North Texas Health Science Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 9, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 16, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 27, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • W81XWH-13-2-0065
  • 1 I01 CX001136-01 (Other Grant/Funding Number: Veterans Affairs)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings