TraumaNCT02773693
Treatment of Comorbid Sleep Disorders and Post Traumatic Stress Disorder (PTSD)
A study testing Cognitive Processing Therapy-Cognitive Only (CPT), Cognitive Behavioral Therapy of Insomnia and Nightmares (CBTin) and Continuation Cognitive Processing Therapy-Cognitive Only (CPT) in people with Trauma and Insomnia, run by University of North Texas, Denton, TX at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Trauma, Insomnia, Nightmares
- What is being tested?
- Cognitive Processing Therapy-Cognitive Only (CPT), Cognitive Behavioral Therapy of Insomnia and Nightmares (CBTin) and Continuation Cognitive Processing Therapy-Cognitive Only (CPT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Carl R. Darnall Army Medical Center
Fort Hood, Texas, 76544
About this study
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.
- Conditions
- Trauma, Insomnia, Nightmares
- Being tested
- Cognitive Processing Therapy-Cognitive Only (CPT), Cognitive Behavioral Therapy of Insomnia and Nightmares (CBTin), Continuation Cognitive Processing Therapy-Cognitive Only (CPT)
- Medical subject headings
- Wounds and Injuries, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Processing Therapy-Cognitive Only (CPT)Behavioural
Twice weekly CPT over 6 weeks.
Cognitive Behavioral Therapy of Insomnia and Nightmares (CBTin)Behavioural
Cognitive behavioral therapy of insomnia and nightmares weekly over 6 weeks.
Continuation Cognitive Processing Therapy-Cognitive Only (CPT)Behavioural
Once weekly continuation CPT over 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| CPT | Active comparator | 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. Receives: Behavioral: Cognitive Processing Therapy-Cognitive Only (CPT); Behavioral: Continuation Cognitive Processing Therapy-Cognitive Only (CPT) |
| CBTin+CPT | Active comparator | 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. Receives: Behavioral: Cognitive Processing Therapy-Cognitive Only (CPT); Behavioral: Cognitive Behavioral Therapy of Insomnia and Nightmares (CBTin) |
| CPT+CBTin | Active comparator | 12 twice-weekly sessions of CPT followed by 6 sessions of CBTin. Receives: Behavioral: Cognitive Processing Therapy-Cognitive Only (CPT); Behavioral: Cognitive Behavioral Therapy of Insomnia and Nightmares (CBTin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (2)
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.
Measured: 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
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.
Measured: Change from baseline to 1-month post-treatment (i.e., after the completion of all 18 sessions, not to exceed 22 weeks from baseline).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2016 (estimated)
- Study startAug 2016
- Primary completionSep 2019 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Texas, Denton, TX
- Sponsor type
- University, hospital or other
- 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.
- Responsible party
- Sponsor
- Investigators
- Daniel J Taylor, Ph.D., Principal investigator, University of North Texas Health Science Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02773693
- Sponsor's protocol ID
- W81XWH-13-2-0065
- Other IDs
- 1 I01 CX001136-01
- Status last verified
- Sep 2018
- First submitted
- 9 May 2016
- Last updated
- 27 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Taylor DJ, Pruiksma KE, Mintz J, Slavish DC, Wardle-Pinkston S, Dietch JR, Dondanville KA, Young-McCaughan S, Nicholson KL, Litz BT, Keane TM, Peterson AL, Resick PA; Consortium to Alleviate PTSD. Treatment of comorbid sleep disorders and posttraumatic stress disorder in U.S. active duty military personnel: A pilot randomized clinical trial. J Trauma Stress. 2023 Aug;36(4):712-726. doi: 10.1002/jts.22939. Epub 2023 Jun 15.
PubMed 37322836Miles 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.
PubMed 35197191
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Comorbid Sleep Disorders and Post Traumatic Stress Disorder (PTSD)
- ClinicalTrials.gov ID
- NCT02773693
- Acronym / sponsor ID
- W81XWH-13-2-0065
- Conditions
- Trauma, Insomnia, Nightmares
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (actual)
- Lead sponsor
- University of North Texas, Denton, TXUniversity, hospital or other
- 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.
- Study start
- Aug 2016
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 16 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CPT | Active comparator | Behavioral: Cognitive Processing Therapy-Cognitive Only (CPT), Behavioral: Continuation Cognitive Processing Therapy-Cognitive Only (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. |
| CBTin+CPT | Active comparator | Behavioral: Cognitive Processing Therapy-Cognitive Only (CPT), Behavioral: Cognitive Behavioral Therapy of Insomnia and Nightmares (CBTin)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. |
| CPT+CBTin | Active comparator | Behavioral: Cognitive Processing Therapy-Cognitive Only (CPT), Behavioral: Cognitive Behavioral Therapy of Insomnia and Nightmares (CBTin)12 twice-weekly sessions of CPT followed by 6 sessions of CBTin. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Processing Therapy-Cognitive Only (CPT)Twice weekly CPT over 6 weeks. | Behavioural | CBTin+CPT, CPT, CPT+CBTin |
| Cognitive Behavioral Therapy of Insomnia and Nightmares (CBTin)Cognitive behavioral therapy of insomnia and nightmares weekly over 6 weeks. | Behavioural | CBTin+CPT, CPT+CBTin |
| Continuation Cognitive Processing Therapy-Cognitive Only (CPT)Once weekly continuation CPT over 6 weeks. | Behavioural | CPT |
Primary outcome
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.
2 secondary outcomes
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).
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2018.
- Derived from this study: PubMed 37322836Taylor DJ, Pruiksma KE, Mintz J, Slavish DC, Wardle-Pinkston S, Dietch JR, Dondanville KA, Young-McCaughan S, Nicholson KL, Litz BT, Keane TM, Peterson AL, Resick PA; Consortium to Alleviate PTSD. Treatment of comorbid sleep disorders and posttraumatic stress disorder in U.S. active duty military personnel: A pilot randomized clinical trial. J Trauma Stress. 2023 Aug;36(4):712-726. doi: 10.1002/jts.22939. Epub 2023 Jun 15.
- Derived from this study: PubMed 35197191Miles 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel J Taylor, Ph.D. principal investigator
University of North Texas Health Science Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Processing Therapy-Cognitive Only (CPT), Cognitive Behavioral Therapy of Insomnia and Nightmares (CBTin) and Continuation Cognitive Processing Therapy-Cognitive Only (CPT) in people with Trauma and Insomnia, run by University of North Texas, Denton, TX at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02773693, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2018.