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

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02773693
• Other study ID #: W81XWH-13-2-0065
• Secondary ID: 1 I01 CX001136-0
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 2016
• Est. completion date: September 2020

Study information

• Verified date: September 2018
• Source: University of North Texas, Denton, TX
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 94
• Est. completion date: September 2020
• Est. primary completion date: September 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Insomnia
• Nightmares
• Parasomnias
• Sleep Wake Disorders
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Trauma

Intervention

Behavioral:
• Cognitive Processing Therapy-Cognitive Only (CPT)
Twice weekly CPT over 6 weeks.
• Cognitive Behavioral Therapy of Insomnia and Nightmares (CBTin)
Cognitive behavioral therapy of insomnia and nightmares weekly over 6 weeks.
• Continuation Cognitive Processing Therapy-Cognitive Only (CPT)
Once weekly continuation CPT over 6 weeks.

Locations

Country	Name	City	State
United States	Carl R. Darnall Army Medical Center	Fort Hood	Texas

Sponsors (6)

Lead Sponsor	Collaborator
University of North Texas, Denton, TX	Boston VA Research Institute, Inc., Duke University, Durham VA Medical Center, South Texas Veterans Health Care System, The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	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.	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	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.	Change from baseline to 1-month post-treatment (i.e., after the completion of all 18 sessions, not to exceed 22 weeks from baseline).