Ignite Creation Date:
2024-05-06 @ 12:53 AM
Last Modification Date:
2024-10-26 @ 10:56 AM
Study NCT ID:
NCT01686438
Status:
COMPLETED
Last Update Posted:
2019-08-29
First Post:
2012-09-06
Brief Title:
Telemedicine Management of Chronic Insomnia
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Telemedicine Management of Veterans With PTSD and Chronic Insomnia
Status:
COMPLETED
Status Verified Date:
2019-07
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:
VIP
Brief Summary:
Insomnia is commonly present in Veterans with post-traumatic stress disorder PTSD Treatment of insomnia with a specialized type of psychotherapy has been shown to be more effective than treatment with medications Unfortunately few psychologists are trained to provide this treatment limiting Veterans access to care especially those Veterans in remote and rural areas This project will evaluate the ability to deliver this psychotherapy to groups of Veterans by video teleconferencing Groups of Veterans with PTSD and chronic insomnia will receive the psychotherapy treatment either by meeting in-person with the psychologist or by the psychologist delivering the treatment by video teleconferencing Finding that video teleconferencing is a cost effective way to deliver this treatment could add an important new component to the care of Veterans with PTSD that provides an alternative to medications
Detailed Description:
Objectivess The investigators are conducting a randomized controlled trial of Veterans with PTSD and chronic insomnia to determine if cognitive behavioral therapy for insomnia CBT-I administered by video teleconferencing is not clinically inferior to in-person treatment in terms of improvement in insomnia symptoms Secondary aims are 1 comparing the differences in cost and quality-adjusted life years between the treatment delivery approaches and 2 determining the effectiveness of CBT-I on functional outcomes sleep quality and non-sleep-related PTSD symptoms The investigators are also conducting a patient- and provider-focused formative evaluation of CBT-I delivery by video teleconferencing to assess potential barriers to its widespread implementation
Research Design This prospective randomized controlled non-inferiority study will determine if Veterans with PTSD and chronic insomnia receiving CBT-I by video teleconferencing have an improvement in insomnia severity as determined by change in Insomnia Severity Index ISI score that is not clinically inferior to that in Veterans receiving in-person CBT-I Differences in cost and quality-adjusted life years QALY between groups will also be compared
Methodology Veterans with PTSD and chronic insomnia receiving their primary care at community-based outpatient clinics CBOC affiliated with the Philadelphia VAMC are be randomized to receive one of the following interventions in a group setting at their CBOC 1 a manual-based CBT-I program delivered via video teleconferencing 2 the CBT-I program delivered in-person and 3 in-person delivery of sleep hygiene education a known active control intervention Participants are assessed at baseline and 2 weeks and every 3 months following the intervention The primary outcome measure in Aim 1 is the change in the Insomnia Severity Index ISI score at 6 months following intervention Non-inferiority analysis will be used to compare the effectiveness of the two delivery methods with a pre-specified margin Results will be ascertained via intent to treat and per-protocol procedures The investigators hypothesize that the change in ISI score following CBT-I by video teleconferencing will not be clinically inferior to that following in-person delivery In Aim 2 VA and non-VA total healthcare costs are being collected to test whether average cost is lower for Veterans receiving CBT-I by video teleconferencing versus in-person care Preference is being assessed by the EuroQol and Health Utilities Index 2 Differences in the ratio of cost and quality-adjusted life years saved between CBT-I by video teleconferencing and in-person encounter will be compared to test the hypothesis that video teleconferencing will have lower cost and equivalent outcomes Aim 3 is assessing the effect of CBT-I on functional outcomes Short Form-12 Work and Social Adjustment Scale sleep quality Pittsburgh Sleep Quality Index sleep diary and wrist actigraphy and PTSD severity the non-sleep component of the PTSD Checklist-Military The investigators hypothesize that these functional outcomes and sleep quality measures will improve following each method of CBT-I delivery and that CBT-I will improve non-sleep-related PTSD severity The formative evaluation of the telemedicine delivery of CBT-I in Aim 4 is using qualitative targeted focus groups with participants and therapist interviews and quantitative measures Work Alliance Inventory Treatment Credibility Scale attrition that will help guide future implementation of CBT-I by video teleconferencing
Anticipated Findings The investigators believe these results will demonstrate that 1 Veterans in both CBT-I groups will have similar improvement in functional outcomes and 2 treatment delivery by video teleconferencing will be more cost effective than in-person care These findings should lead to wider acceptance of video teleconferencing thereby increasing patient access to care and reducing treatment costs
Research Design This prospective randomized controlled non-inferiority study will determine if Veterans with PTSD and chronic insomnia receiving CBT-I by video teleconferencing have an improvement in insomnia severity as determined by change in Insomnia Severity Index ISI score that is not clinically inferior to that in Veterans receiving in-person CBT-I Differences in cost and quality-adjusted life years QALY between groups will also be compared
Methodology Veterans with PTSD and chronic insomnia receiving their primary care at community-based outpatient clinics CBOC affiliated with the Philadelphia VAMC are be randomized to receive one of the following interventions in a group setting at their CBOC 1 a manual-based CBT-I program delivered via video teleconferencing 2 the CBT-I program delivered in-person and 3 in-person delivery of sleep hygiene education a known active control intervention Participants are assessed at baseline and 2 weeks and every 3 months following the intervention The primary outcome measure in Aim 1 is the change in the Insomnia Severity Index ISI score at 6 months following intervention Non-inferiority analysis will be used to compare the effectiveness of the two delivery methods with a pre-specified margin Results will be ascertained via intent to treat and per-protocol procedures The investigators hypothesize that the change in ISI score following CBT-I by video teleconferencing will not be clinically inferior to that following in-person delivery In Aim 2 VA and non-VA total healthcare costs are being collected to test whether average cost is lower for Veterans receiving CBT-I by video teleconferencing versus in-person care Preference is being assessed by the EuroQol and Health Utilities Index 2 Differences in the ratio of cost and quality-adjusted life years saved between CBT-I by video teleconferencing and in-person encounter will be compared to test the hypothesis that video teleconferencing will have lower cost and equivalent outcomes Aim 3 is assessing the effect of CBT-I on functional outcomes Short Form-12 Work and Social Adjustment Scale sleep quality Pittsburgh Sleep Quality Index sleep diary and wrist actigraphy and PTSD severity the non-sleep component of the PTSD Checklist-Military The investigators hypothesize that these functional outcomes and sleep quality measures will improve following each method of CBT-I delivery and that CBT-I will improve non-sleep-related PTSD severity The formative evaluation of the telemedicine delivery of CBT-I in Aim 4 is using qualitative targeted focus groups with participants and therapist interviews and quantitative measures Work Alliance Inventory Treatment Credibility Scale attrition that will help guide future implementation of CBT-I by video teleconferencing
Anticipated Findings The investigators believe these results will demonstrate that 1 Veterans in both CBT-I groups will have similar improvement in functional outcomes and 2 treatment delivery by video teleconferencing will be more cost effective than in-person care These findings should lead to wider acceptance of video teleconferencing thereby increasing patient access to care and reducing treatment costs
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