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Behavioral Intervention

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

N/A
Waitlist Available
Led By Daniel J Taylor, Ph.D.
Research Sponsored by University of North Texas, Denton, TX
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to 1-month post-treatment (i.e., after the completion of all 18 sessions, not to exceed 22 weeks from baseline).
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Insomnia
  • Trauma
  • Nightmares

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to 1-month post-treatment (i.e., after the completion of all 18 sessions, not to exceed 22 weeks from baseline).
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to 1-month post-treatment (i.e., after the completion of all 18 sessions, not to exceed 22 weeks from baseline). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Clinician Administered PTSD Scale (CAPS-5)
Secondary study objectives
PTSD Checklist -DSM-5 (PCL-5)
Sleep Diary Sleep Efficiency

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Active Control
Group I: CBTin+CPTActive Control2 Interventions
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.
Group II: CPTActive Control2 Interventions
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.
Group III: CPT+CBTinActive Control2 Interventions
12 twice-weekly sessions of CPT followed by 6 sessions of CBTin.

Find a Location

Who is running the clinical trial?

Duke UniversityOTHER
2,461 Previous Clinical Trials
2,969,413 Total Patients Enrolled
Durham VA Medical CenterFED
39 Previous Clinical Trials
9,249 Total Patients Enrolled
Boston VA Research Institute, Inc.OTHER
23 Previous Clinical Trials
10,752 Total Patients Enrolled
University of North Texas, Denton, TXLead Sponsor
12 Previous Clinical Trials
6,967 Total Patients Enrolled
The University of Texas Health Science Center at San AntonioOTHER
476 Previous Clinical Trials
92,848 Total Patients Enrolled
2 Trials studying Nightmares
97 Patients Enrolled for Nightmares
South Texas Veterans Health Care SystemFED
18 Previous Clinical Trials
5,972 Total Patients Enrolled
Daniel J Taylor, Ph.D.Principal InvestigatorUniversity of North Texas Health Science Center
2 Previous Clinical Trials
287 Total Patients Enrolled
~10 spots leftby Dec 2025