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New treatment option for Insomnia
Official title Treatments for Insomnia in Veterans With PTSD
ClinicalTrials.gov ID: NCT05194930
What this study is testing
- What it's testing
- This randomized trial will compare a novel treatment, Acceptance of the Behavioral Changes to Treat Insomnia (ABC-I) to Cognitive Behavioral Therapy for Insomnia (CBT-I) among Veterans with comorbid Post-Traumatic Stress Disorder (PTSD) and insomnia disorder. ABC-I combines the behavioral components of CBT-I with components of another behavioral therapy (Acceptance and Commitment Therapy) and has been shown to improve treatment adherence.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- community-dwelling Veterans aged 18 years and older,
- received care from VAGLAHS in the prior year,
- live within a 50-mile radius of the research offices at the VA Sepulveda Ambulatory Care Center,
- have symptoms of PTSD,
- have symptoms of insomnia.
You likely can't join if
- current pregnancy or has a child less than 6 months of age (men and women),
- active substance users or in recovery with less than 90 days of sobriety,
- too ill to engage in the study procedures,
- unable to self-consent to participate,
- unstable housing (since we may not be able to retrieve costly and difficult to replace monitoring equipment),
- severe, untreated sleep disordered breathing (AHI\>15 with excessive daytime sleepiness, or AHI\>30),
See the full eligibility criteria
- community-dwelling Veterans aged 18 years and older,
- received care from VAGLAHS in the prior year,
- live within a 50-mile radius of the research offices at the VA Sepulveda Ambulatory Care Center,
- have symptoms of PTSD,
- have symptoms of insomnia.
- current pregnancy or has a child less than 6 months of age (men and women),
- active substance users or in recovery with less than 90 days of sobriety,
- too ill to engage in the study procedures,
- unable to self-consent to participate,
- unstable housing (since we may not be able to retrieve costly and difficult to replace monitoring equipment),
- severe, untreated sleep disordered breathing (AHI\>15 with excessive daytime sleepiness, or AHI\>30),
- restless legs syndrome that accounts for the sleep disturbances reported,
- a circadian rhythm sleep disorder that accounts for the sleep disturbances reported (including shift work sleep disorder),
- unstable medical or psychiatric disorders (which is a contraindication for behavioral treatment of insomnia);
- remission of insomnia symptoms prior to randomization;
- current participation in prolonged exposure therapy for PTSD.
The study team makes the final eligibility decision.
Where it's taking place
- Sepulveda, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sepulveda, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.