← Back to Search

Cognitive-Behavioral Therapy for Insomnia for Insomnia

N/A
Waitlist Available
Led By Henry J. Orff, PhD
Research Sponsored by VA Office of Research and Development
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 3-weeks, 6-weeks, 10-weeks
Awards & highlights

Study Summary

This trial will assess whether CBT-I is an effective treatment for insomnia in Veterans with mTBI.

Eligible Conditions
  • Insomnia
  • Traumatic Brain Injury

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-weeks, 6-weeks, 10-weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-weeks, 6-weeks, 10-weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Sleep Efficiency
Secondary outcome measures
Change in PTSD Stressor Specific Checklist 5
Change in World Health Organization Disability Assessment Scale-2
Change in depressive symptomatology
Other outcome measures
Change in Patient Reported Outcomes Measurement Information System (PROMIS) pain
Change in global deficit score (composite score) of neuropsychological functioning
Change in sleep efficiency as measured by polysomnography

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Cognitive-Behavioral Therapy for InsomniaExperimental Treatment1 Intervention
6-week manualized treatment designed to improve symptoms of chronic insomnia.
Group II: Sleep EducationActive Control1 Intervention
6-week manualized treatment designed to provide information regarding traumatic brain injury and its relationship to sleep disturbance, which incorporates training in sleep hygiene to help improve nighttime sleep and daytime functioning.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive-Behavioral Therapy for Insomnia
2016
Completed Phase 2
~260

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,530 Total Patients Enrolled
26 Trials studying Insomnia
4,124 Patients Enrolled for Insomnia
Henry J. Orff, PhDPrincipal InvestigatorVA San Diego Healthcare System, San Diego, CA
1 Previous Clinical Trials
250 Total Patients Enrolled
1 Trials studying Insomnia
250 Patients Enrolled for Insomnia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
CBT-I for Veterans With TBI
2016. "CBT-I for Veterans With TBI". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02658669.
~8 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top