An interventional study of Internet-based Self-help Insomnia Intervention in Insomnia, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-21.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Health services research
Internet-based self-help programs are personalized, self-guided interventions delivered over a computer, mobile device, or other Internet platform and focused on improving knowledge, awareness, or behavior change for a mental or physical health problem. Through previous and on-going projects at VACT, the investigators are developing a general strategy for implementing Internet-based Self-help programs in VA primary care, specifically among Patient Aligned Care Teams (PACT) and Primary Care Mental Health Integration (PCMHI) providers. An implementation strategy is defined as a systematic intervention to integrate evidence-based health innovations into usual care. The strategy the investigators propose to test consists of four core components: (1) a clinical intermediary for patient support, (2) provider/staff facilitation and education, (3) patient education, and (4) stepped-care for those requiring additional treatment. In the proposed study, the investigators will compare this strategy to a low intensity (control) strategy with respect to the implementation related outcomes of patent engagement, provider adoption through referral to the program, and patient completion, over a six-month active implementation period. The investigators will target the very common clinical problem of insomnia and use the SHUTiTM program, a 6-week self-guided program utilizing standard cognitive-behavioral therapy (CBT) techniques for the treatment of chronic insomnia. The program has been shown to improve insomnia severity and other sleep related outcomes in a number of controlled trials. The clinical effectiveness of SHUTiTM will be evaluated using clinical insomnia outcomes obtained on all patients enrolled over the 6-month active implementation periods. The purpose this study is to evaluate the preliminary (1) effectiveness of an implementation strategy for Internet-based Self-help Interventions and (2) clinical outcomes of a specific Internet-based self-help program for insomnia, SHUTiTM, in VA Connecticut outpatient primary care. The primary hypothesis is that the experimental implementation strategy the investigators are developing, relative to a control strategy, will result in higher rates of program engagement by patients, greater provider adoption through referral to the program, greater program completion, and improved patient insomnia outcomes.
Objective: The purpose this study is to evaluate the preliminary (1) effectiveness of an implementation strategy for Internet-based Self-help Interventions and (2) clinical outcomes of a specific Internet-based self-help program for insomnia, SHUTiTM, in VA Connecticut outpatient primary care. The primary hypothesis is that the experimental implementation strategy the investigators are developing, relative to a control strategy, will result in higher rates of program engagement by patients, greater provider adoption through referral to the program, greater program completion, and improved patient insomnia outcomes.
Research Design: The investigators will employ a hybrid implementation-effectiveness study design through which the investigators will primarily test the effectiveness of the implementation strategy, while secondarily evaluating the clinical effectiveness of the SHUTiTM program. The investigators will use a quasi-experimental pre-/post-cohort design whereby SHUTiTM will initially be implemented using a low-intensity (control) strategy, followed by implementation using the experimental strategy. The SHUTiTM program's association with clinical response will be evaluated in an uncontrolled pre-/post-format.
Methodology: Internet-based self-help programs are personalized, self-guided interventions delivered over a computer, mobile device, or other Internet platform and focused on improving knowledge, awareness, or behavior change for a mental or physical health problem. Through previous and on-going projects at VACT, the investigators are developing a general strategy for implementing Internet-based Self-help programs in VA primary care, specifically among Patient Aligned Care Teams (PACT) and Primary Care Mental Health Integration (PCMHI) providers. An implementation strategy is defined as a systematic intervention to integrate evidence-based health innovations into usual care. The strategy the investigators propose to test consists of four core components: (1) a clinical intermediary for patient support, (2) provider/staff facilitation and education, (3) patient education, and (4) stepped-care for those requiring additional treatment. The investigators' currently approved protocol (#0002) involves interviewing VA providers, administrators, and staff in order to expand and modify the components of this strategy. In the proposed study, the investigators will compare this strategy to a low intensity (control) strategy with respect to the implementation related outcomes of patent engagement, provider adoption through referral to the program, and patient completion, over a six-month active implementation period. Use of the program will continue and implementation outcomes will be gathered over an additional one-year sustainment phase. The investigators will target the very common clinical problem of insomnia and use the SHUTiTM program, a 6-week self-guided program utilizing standard cognitive-behavioral therapy (CBT) techniques for the treatment of chronic insomnia. The program has been shown to improve insomnia severity and other sleep related outcomes in a number of controlled trials. The clinical effectiveness of SHUTiTM will be evaluated using clinical insomnia outcomes obtained on all patients enrolled over the 6-month active implementation periods.
Impact/Significance: The development and testing of evidence-based implementation strategies for Internet-based self-help programs in VA outpatient care is essential given that (1) there is an increasing number of Internet-based self-help programs providing evidence-based treatment for a variety of mental and behavioral health disorders, (2) VA has committed to improving access to care, especially evidence-based and self-care resources, and (3) there is a Congressional mandate that VA implement Internet-based care. This will be first controlled trial of an implementation strategy for Internet-based self-help programs in a VA primary care (PACT/PCMHI) context.
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Exclusion Criteria:
SHUTi digital CBTi Program was implemented in VACT primary care using implementation activities executed by the research team between June 2017 and January 2018 (8-months). Implementation activities included: Provider Education by the research team, Provider Reminders (information pamphlets in treatment rooms), Patient Advertising/Information (information pamphlets in treatment rooms), Single Referral Pathway Not Integrated Primary Care Workflow (Primary care provider contact research team for patient referral over email).
Behavioral: Internet-based Self-help Insomnia Intervention
SHUTi digital CBTi Program implemented in VACT primary care using implementation activities executed by primary care teams June 2018 and January 2019 (8-months). Implementation activities included: Provider Education by the research team, Provider Reminders (information pamphlets in treatment rooms), Patient Advertising/Information (information pamphlets in treatment rooms), patient education and motivational support supplied through a digital CBTi coach, the digital CBTi coach was a primary care nurse trained by the research team, technical support and oversight of the digital CBTi coach by the research team. Single Referral Pathway Not Integrated Primary Care Workflow.
Behavioral: Internet-based Self-help Insomnia Intervention
SHUTi digital CBTi Program implemented in VACT primary care using implementation activities executed by primary care teams April 2019 and November 2019 (8-months). Implementation activities included: Provider Education by the research team, Provider Reminders, Patient Advertising/Information, patient education and motivational support supplied through a digital CBTi coach, the digital CBTi coach was a peer support specialist working on the primary care mental health collaborative care team, the digital CBTi coach was trained by the research team, technical support and oversight of the digital CBTi coach by the research team. Additional members primary care mental health collaborative care team were educated to provide education about digital CBTi. Multiple referral pathways to digital CBTi: consults to the digital CBTi Coach, warm handoffs to primary care mental health collaborative care team. Digital CBTi coach consults integrated Primary Care Workflow.
Behavioral: Internet-based Self-help Insomnia Intervention
The investigators will use the program, SHUTiTM for the treatment of insomnia. The intervention is a CBT-based 6-week, self-administered course accessed via the Internet on mobile, desk-top, and other devices. The program is split into six modules, completed weekly, which include instruction on psycho-education, stimulus control, relaxation training, sleep restriction, medication tapering, and addressing cognitive distortions. The content is delivered via text, video vignettes, case histories, interactive learning tools, interactive skills assessments, symptom assessments, and a sleep log. Homework is assigned after each module. Providers and support staff can follow treatment progress via access to a dashboard of patient information collected by the program. Such information includes progress through the modules, date of last engagement, symptom assessment outcomes, and sleep log data abstracted into commonly used sleep indices such as sleep onset latency and sleep efficiency.
Also known as: SHUTi (Sleep Health Using the Internet)
Program Engagement: Completion of the First Program Module
The proportion of participants engaging in the program (completing at least one module) among the unique Veterans treated in VA Connecticut primary care over the respective intervention periods.
Time frame: 3 weeks following subject enrollment
Program Completion
Completion of all six modules of the program. The proportion of individuals completing all six modules among all individuals enrolled.
Time frame: 10 Weeks following subject enrollment
Provider Adoption
The number of providers who made a referral to the SHUTi Program among the number of providers with the ability to make a referral.
Time frame: Over each 8-month active implementation Phase
Insomnia Severity Index
The ISI will be the primary clinical outcome and is a self-report seven-item measure that targets the subjective symptoms and functional consequences of insomnia. The outcome reported is the change in total ISI score from baseline to follow-up. All enrollees are analyzed as a single group regardless of implementation period. The Insomnia Severity Index to total is the sum on 7 questions scored 0 to 4 (minimum=0, Maximum=28). Higher scores indicate more severe insomnia.
Time frame: At enrollment and 10 weeks following enrollment.
Beck Depression Inventory
The BDI is a secondary clinical outcome and is a self-report measure of depression severity. The outcome reported is the change in total BDI score from baseline to follow-up. All enrollees are analyzed as a single group regardless of implementation period. The BDI is a 21-item, self-report rating inventory of depression symptoms. Items receive a rating of zero to three and are summed linearly to create a score which ranges from 0 to 63. Higher score indicate more intense symptoms of depression.
Time frame: At enrollment and 10 weeks following enrollment
Sedative-Hypnotic Medication Use
The use of sedative-hypnotics will be measured by self-report of the type and dose of specific medications used in the last week. The outcome reported is the change in the reported total weekly number of sedative-hypnotic doses reported from baseline compared to follow-up.
Time frame: At enrollment and 10 weeks following enrollment
Recruitment to digital CBTi occurred through primary care providers who made a referrals to the intervention. Referrals were addressed by the digital intervention coach (or research team member, depending on the cohort), who provided and initial education session about digital CBTi. Participants could then enroll in the trial if they wished. Over the entire course of the trial, 153 individuals were referred and 77 chose to enroll.
| Milestone | Phase 1: Implementation As Usual (Implementation Through Research Team) | Phase 2: Primary Care Coached Digital CBTi Implementation (Implementation Through Primary Care) | Phase 3: Primary Care Mental Health Collaborative Care Implementation |
|---|---|---|---|
| Started | 27 | 20 | 30 |
| Completed | 25 | 19 | 26 |
| Not completed | 2 | 1 | 4 |
The proportion of participants engaging in the program (completing at least one module) among the unique Veterans treated in VA Connecticut primary care over the respective intervention periods.
| Participants | Phase 1: Implementation As Usual (Implementation Through Research Team) | Phase 2: Primary Care Coached Digital CBTi Implementation (Implementation Through Primary Care) | Phase 3: Primary Care Mental Health Collaborative Care Implementation |
|---|---|---|---|
| Program Engagement: Completion of the First Program Module | 17 | 12 | 16 |
Completion of all six modules of the program. The proportion of individuals completing all six modules among all individuals enrolled.
| Participants | Phase 1: Implementation As Usual (Implementation Through Research Team) | Phase 2: Primary Care Coached Digital CBTi Implementation (Implementation Through Primary Care) | Phase 3: Primary Care Mental Health Collaborative Care Implementation |
|---|---|---|---|
| Program Completion | 10 | 7 | 7 |
The number of providers who made a referral to the SHUTi Program among the number of providers with the ability to make a referral.
| Participants | Phase 1: Implementation As Usual (Implementation Through Research Team) | Phase 2: Primary Care Coached Digital CBTi Implementation (Implementation Through Primary Care) | Phase 3: Primary Care Mental Health Collaborative Care Implementation |
|---|---|---|---|
| Provider Adoption | 31 | 26 | 34 |
The ISI will be the primary clinical outcome and is a self-report seven-item measure that targets the subjective symptoms and functional consequences of insomnia. The outcome reported is the change in total ISI score from baseline to follow-up. All enrollees are analyzed as a single group regardless of implementation period. The Insomnia Severity Index to total is the sum on 7 questions scored 0 to 4 (minimum=0, Maximum=28). Higher scores indicate more severe insomnia.
| score on a scale | All Enrollees |
|---|---|
| Insomnia Severity Index | 4.3 ± 5.6 |
The BDI is a secondary clinical outcome and is a self-report measure of depression severity. The outcome reported is the change in total BDI score from baseline to follow-up. All enrollees are analyzed as a single group regardless of implementation period. The BDI is a 21-item, self-report rating inventory of depression symptoms. Items receive a rating of zero to three and are summed linearly to create a score which ranges from 0 to 63. Higher score indicate more intense symptoms of depression.
| score on a scale | All Enrollees |
|---|---|
| Beck Depression Inventory | 3.1 ± 5.5 |
The use of sedative-hypnotics will be measured by self-report of the type and dose of specific medications used in the last week. The outcome reported is the change in the reported total weekly number of sedative-hypnotic doses reported from baseline compared to follow-up.
| weekly sedative-hypnotic doses | All Enrollees |
|---|---|
| Sedative-Hypnotic Medication Use | 2.2 ± 6.6 |
Collected over Adverse event data was collected over the entire trial period between June 2017 and January 2020. This timeframe included the 3 periods of active implementation (when referrals could be made to the program) in addition to periods where subjects who had enrolled could actively engage in the SHUTi (up to 10 weeks after enrollment).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Enrollees | 0/77 (0%) | 0/77 (0%) | 0/77 (0%) |
| Age, Customized(Participants) | Phase 1: Implementation As Usual (Implementation Through Research Team) | Phase 2: Primary Care Coached Digital CBTi Implementation (Implementation Through Primary Care) | Phase 3: Primary Care Mental Health Collaborative Care Implementation | Total |
|---|---|---|---|---|
| <=55 | 8 | 7 | 7 | 22 |
| >55,<=65 | 9 | 4 | 9 | 22 |
| >65 | 10 | 9 | 14 | 33 |
| Sex: Female, Male(Participants) | Phase 1: Implementation As Usual (Implementation Through Research Team) | Phase 2: Primary Care Coached Digital CBTi Implementation (Implementation Through Primary Care) | Phase 3: Primary Care Mental Health Collaborative Care Implementation | Total |
|---|---|---|---|---|
| Female | 4 | 1 | 6 | 11 |
| Male | 23 | 19 | 24 | 66 |
| Race/Ethnicity, Customized(Participants) | Phase 1: Implementation As Usual (Implementation Through Research Team) | Phase 2: Primary Care Coached Digital CBTi Implementation (Implementation Through Primary Care) | Phase 3: Primary Care Mental Health Collaborative Care Implementation | Total |
|---|---|---|---|---|
| White/non-Hispanic | 21 | 13 | 24 | 58 |
| African American/Non-Hispanic | 2 | 4 | 3 | 9 |
| Hispanic | 3 | 2 | 2 | 7 |
| Other | 1 | 1 | 1 | 3 |
| Any Mental Health Diagnosis(Participants) | Phase 1: Implementation As Usual (Implementation Through Research Team) | Phase 2: Primary Care Coached Digital CBTi Implementation (Implementation Through Primary Care) | Phase 3: Primary Care Mental Health Collaborative Care Implementation | Total |
|---|---|---|---|---|
| Any Mental Health Diagnosis | 12 | 8 | 15 | 35 |
| No Mental Health Diagnosis | 15 | 12 | 15 | 42 |
| Number of Medical Diagnoses(Participants) | Phase 1: Implementation As Usual (Implementation Through Research Team) | Phase 2: Primary Care Coached Digital CBTi Implementation (Implementation Through Primary Care) | Phase 3: Primary Care Mental Health Collaborative Care Implementation | Total |
|---|---|---|---|---|
| <5 | 4 | 6 | 7 | 17 |
| >=5, <10 | 10 | 4 | 7 | 21 |
| >=10 | 13 | 10 | 16 | 39 |
| Any Sedative-Hypnotic Prescription(Participants) | Phase 1: Implementation As Usual (Implementation Through Research Team) | Phase 2: Primary Care Coached Digital CBTi Implementation (Implementation Through Primary Care) | Phase 3: Primary Care Mental Health Collaborative Care Implementation | Total |
|---|---|---|---|---|
| Any Sedative-Hypnotic Prescription | 6 | 4 | 12 | 22 |
| No Sedative-Hypnotic Prescription | 21 | 16 | 18 | 55 |
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