Ignite Creation Date:
2024-05-06 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05724498
Status:
RECRUITING
Last Update Posted:
2024-05-03
First Post:
2023-02-02
Brief Title:
Brief Versus Standard Cognitive Behavioral Therapy for Insomnia in Veterans
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
A Randomized Clinical Trial Comparing Brief and Standard Cognitive-Behavioral Therapies for Insomnia in Veterans
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Insomnia is a common condition in Veterans with prevalence rates as high as 53 among treatment-seeking Veterans Chronic untreated insomnia is associated with increased risk for functional impairment psychiatric illness suicidal ideation unhealthy lifestyles and decreased quality of life Cognitive-Behavioral Therapy for Insomnia CBT-I is recognized as the first-line treatment for insomnia Despite its proven efficacy CBT-I is not always readily provided andor accessible to Veterans To address these limitations behavioral sleep medicine specialists have endeavored to streamline CBT-I through development of time-shortened variations of CBT-I Although these modifications show promise for advancing care and access studies comparing brief treatments to standard CBT-I have yet to be performed This investigation will therefore compare a 4-session brief CBT-I to VA standard 6-session CBT-I to evaluate whether a brief intervention can provide comparable benefits to sleep functional and psychiatric outcomes in Veterans with insomnia
Detailed Description:
Veterans seen in VA primary care and mental health clinics commonly present with complaints of sleep disturbance especially insomnia For example in a cross-sectional study examining sleep disorders among Veterans seeking care through the Veterans Health Administration between 2000-2010 sleep apnea 47 and insomnia 26 were the most commonly diagnosed conditions In a study of 375 Operation Enduring FreedomOperation Iraqi Freedom Veterans 45 reported extended time spent trying to fall asleep 30 minutes 21 reported reduced total sleep times 45 hours and 56 reported being awake in bed more than 15 of the night Similarly in another observational study of 5552 Veterans 572 of the sample population was found to have insomnia disorder This sample also was at high-risk for a host of clinical disorders including PTSD TBI and pain all of which showed higher rates of insomnia
Cognitive Behavioral Therapy for Insomnia CBT-I is a multi-component intervention that features sleep restriction stimulus control sleep hygiene education cognitive therapy and can include relaxation techniques CBT-I is recognized as the first-line treatment for chronic insomnia and is effective in Veterans however limitations to use still remain In recent years advances in treatment approaches have attempted to streamline CBT-I by focusing on delivery of specific treatment components reducing number of treatment sessions andor use of technologies that provide for ease of dissemination and implementation Brief Cognitive-Behavioral Therapy for Insomnia bCBT-I represents one such empirically tested brief intervention which may decrease patient burden through reduced sessions needed to achieve treatment goals and through use of hybrid treatment administration ie in-person and telemedicine
To better inform both clinical practice and future research this investigation proposes to assess the comparative effectiveness of bCBT-I to VA standard CBT- with several overarching goals 1 in a randomized clinical trial RCT evaluate the equivalence non-inferiority of bCBT-I to VA standard CBT-I 2 evaluate the impact of these treatment approaches on functional rehabilitation outcomes 3 evaluate the impact of these treatment approaches on psychiatric symptomatology and 4 in an exploratory fashion determine which patient factors best predict success or failure with a given treatment as a means of developing insomnia phenotypes that might be used diagnostically to match patient characteristics and type of treatment to help optimize clinical outcomes ie a personalized medicine approach to treatment
The investigation timeline consists of four parts 1 baseline assessment of sleep functional and psychiatric outcome measures 2 randomization and assignment to either CBT-I or bCBT-I 3 post-treatment assessment and 4 3-month follow-up assessment Over 40 months of recruitment this study will enroll and randomize 180 Veterans on a 11 ratio CBT-IbCBT-I 9090 from VA primary care and mental health clinics at two Centers of Excellence sites VA San Diego Healthcare System and Finger Lakes VAMC Healthcare System For the primary study aim one-sided mean difference testing will be conducted with the noninferiority margin added to the null value Secondary analyses will utilize structural equation modeling to evaluate how CBT-I and bCBT-I influence functional and psychosocial outcomes The Exploratory aim will utilize moderation analyses to better understand for whom either CBT-I andor bCBT-I might be more effective
Cognitive Behavioral Therapy for Insomnia CBT-I is a multi-component intervention that features sleep restriction stimulus control sleep hygiene education cognitive therapy and can include relaxation techniques CBT-I is recognized as the first-line treatment for chronic insomnia and is effective in Veterans however limitations to use still remain In recent years advances in treatment approaches have attempted to streamline CBT-I by focusing on delivery of specific treatment components reducing number of treatment sessions andor use of technologies that provide for ease of dissemination and implementation Brief Cognitive-Behavioral Therapy for Insomnia bCBT-I represents one such empirically tested brief intervention which may decrease patient burden through reduced sessions needed to achieve treatment goals and through use of hybrid treatment administration ie in-person and telemedicine
To better inform both clinical practice and future research this investigation proposes to assess the comparative effectiveness of bCBT-I to VA standard CBT- with several overarching goals 1 in a randomized clinical trial RCT evaluate the equivalence non-inferiority of bCBT-I to VA standard CBT-I 2 evaluate the impact of these treatment approaches on functional rehabilitation outcomes 3 evaluate the impact of these treatment approaches on psychiatric symptomatology and 4 in an exploratory fashion determine which patient factors best predict success or failure with a given treatment as a means of developing insomnia phenotypes that might be used diagnostically to match patient characteristics and type of treatment to help optimize clinical outcomes ie a personalized medicine approach to treatment
The investigation timeline consists of four parts 1 baseline assessment of sleep functional and psychiatric outcome measures 2 randomization and assignment to either CBT-I or bCBT-I 3 post-treatment assessment and 4 3-month follow-up assessment Over 40 months of recruitment this study will enroll and randomize 180 Veterans on a 11 ratio CBT-IbCBT-I 9090 from VA primary care and mental health clinics at two Centers of Excellence sites VA San Diego Healthcare System and Finger Lakes VAMC Healthcare System For the primary study aim one-sided mean difference testing will be conducted with the noninferiority margin added to the null value Secondary analyses will utilize structural equation modeling to evaluate how CBT-I and bCBT-I influence functional and psychosocial outcomes The Exploratory aim will utilize moderation analyses to better understand for whom either CBT-I andor bCBT-I might be more effective
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1I01RX003840-01A2 | NIH | None | httpsreporternihgovquickSearch1I01RX003840-01A2 |