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Behavioral Intervention
Behavioral Therapy for Insomnia in Concussions
N/A
Recruiting
Led By Kristi E Pruiksma, PhD
Research Sponsored by The University of Texas Health Science Center at San Antonio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* At least 18 years of age.
* At least 2 postconcussive symptoms scored \> 2 (moderate) on the Neurobehavioral Symptom Inventory (NSI), with at least 1 of these symptoms from the cognitive domain in addition to the sleep disturbances item.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 7 week follow-up, 12 week follow-up
Awards & highlights
No Placebo-Only Group
Summary
This trial will compare the effectiveness of six sessions of Cognitive Behavioral Therapy for Insomnia (CBT-I) with four sessions of Brief Behavioral Therapy for Insomnia (BBT-I) in service members who
Who is the study for?
This trial is for active duty U.S. military service members aged 18 or older who have had a mild traumatic brain injury at least 3 months ago and are experiencing insomnia. They must be able to consent, follow instructions, stay in the area for 3 months, and have stable medication use if applicable.
What is being tested?
The study compares two treatments for insomnia after a brain injury: six sessions of Cognitive Behavioral Therapy (CBT-I) versus four sessions of Brief Behavioral Therapy (BBT-I). Participants will be randomly assigned to one of these two approaches.
What are the potential side effects?
As both interventions involve behavioral therapy rather than medication, side effects may include discomfort with discussing personal issues or temporary increases in distress as sleep patterns are modified.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have moderate postconcussive symptoms, including cognitive issues and sleep problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 7 week follow-up, 12 week follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 7 week follow-up, 12 week follow-up
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Insomnia Severity Index (ISI)
NIH Toolbox v3
Neurobehavioral Symptom Inventory (NSI)
Secondary study objectives
Depressive Symptoms Index-Suicidality Subscale (DSI-SS)
Dysfunctional Beliefs and Attitudes about Sleep (DBAS)
Epworth Sleepiness Scale (ESS)
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Cognitive Behavioral Therapy for InsomniaActive Control1 Intervention
6 weekly, 50-minute sessions delivered individually using in-person or telehealth format by a trained behavioral health provider.
Group II: Brief Behavioral Therapy for InsomniaActive Control1 Intervention
4 weekly, 30-minute sessions delivered individually using in-person or telehealth format by a trained behavioral health provider.
Find a Location
Who is running the clinical trial?
Congressionally Directed Medical Research ProgramsFED
57 Previous Clinical Trials
10,313 Total Patients Enrolled
The University of Texas Health Science Center at San AntonioLead Sponsor
476 Previous Clinical Trials
92,750 Total Patients Enrolled
Hope Health Research InstituteUNKNOWN
Kristi E Pruiksma, PhDPrincipal InvestigatorThe University of Texas Health Science Center at San Antonio