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Non-Pharmacological Treatments for Insomnia in Traumatic Brain Injury
N/A
Waitlist Available
Led By Ansgar J. Furst, 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
Stable adult onset diabetes, controlled with insulin, oral medications or diet is acceptable
Independent Living (not in nursing home or VA Extended Care facility)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline at week 8 after treatment
Awards & highlights
Study Summary
This trial will compare two treatments for insomnia in Veterans with mTBI, to see which is more effective.
Who is the study for?
This trial is for Veterans with chronic mild traumatic brain injury (mTBI) who have been experiencing insomnia for at least 3 months. Participants must be living independently, not in a care facility, and can manage stable health conditions like diabetes. Those with PTSD can join if they don't have depression. People are excluded if they have severe mental or physical health issues, recent trauma, work night shifts, or consume excessive caffeine.Check my eligibility
What is being tested?
The study compares two non-drug treatments for insomnia in individuals with mTBI: Cognitive Behavioral Therapy for Insomnia (CBT-I) and another therapy called ABT-I. The goal is to see which method is more effective in helping Veterans sleep better.See study design
What are the potential side effects?
Since the interventions are non-pharmacological therapies focused on behavior modification and psychological support rather than medication, there may be minimal to no direct side effects; however, changes in sleep patterns or stress levels could potentially occur.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My diabetes is stable and managed with insulin, pills, or diet.
Select...
I live independently, not in a nursing home or VA care facility.
Select...
I have been having trouble sleeping for the last 3 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline at week 8 after treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline at week 8 after treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Insomnia Severity Index (ISI)
Trial Design
2Treatment groups
Experimental Treatment
Group I: CBTIExperimental Treatment1 Intervention
Patients in this arm will receive Cognitive Behavioral Therapy for Insomnia (CBT-I)
Group II: ABTIExperimental Treatment1 Intervention
Arousal-Based Therapy for Insomnia (ABT-I)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CBT-I
2018
Completed Phase 2
~620
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,313 Total Patients Enrolled
Ansgar J. Furst, PhDPrincipal InvestigatorVA Palo Alto Health Care System, Palo Alto, CA
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My diabetes is stable and managed with insulin, pills, or diet.I am currently receiving or planning to receive therapy for a mental health condition.I have a mental health condition that needs immediate treatment.I do not have any severe, uncontrolled health conditions.I live independently, not in a nursing home or VA care facility.I have been having trouble sleeping for the last 3 months.I have PTSD but do not meet the criteria for depression.I am on stable medication that affects my sleep or alertness.I have never been diagnosed with bipolar disorder and do not have thoughts of harming myself or others.I am a veteran with a mild traumatic brain injury for more than 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: CBTI
- Group 2: ABTI
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are new participants being sought for this research project?
"Yes, that is accurate. The clinicaltrials.gov website says that this trial is currently looking for participants. This study was first posted on June 28th, 2018 and was last updated on January 7th, 2022. They are hoping to find 120 people total from 1 site."
Answered by AI
Could you inform me as to how many patients are currently enrolled in this research project?
"The answer is affirmative. According to the information on clinicaltrials.gov, this particular clinical trial is still looking for patients to enroll. The first posting was on 6/28/2018 and the latest update was 1/7/2022. They require 120 individuals in total from at least one location."
Answered by AI
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