InsomniaNCT03151083
Implementing and Evaluating Computer-Based Interventions for Mental Health: Testing an Implementation Strategy for VA Outpatient Care
A study testing Internet-based Self-help Insomnia Intervention in people with Insomnia, run by VA Office of Research and Development at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Insomnia
- What is being tested?
- Internet-based Self-help Insomnia Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2017to 1 Jun 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients Receiving care from a VA Connecticut West Haven PACT/PCMHI Provider
- Diagnosed with insomnia lasting 3 months by the PACT provider, as evidenced by referral by the provider for access to the SHUTiTM program
- Able to provide valid informed consent, as evidenced by answering questions indicating their understanding of the content of the Informed Consent Document
- Willing to participate in an internet-based self-help program for insomnia after the access to and requirements of the program are explained to them
- English-speaking (The SHUTiTM program is only available in English)
Who cannot join
- Evidence of acute psychiatric decompensation requiring inpatient admission or emergency department services within the last month, including suicidality, homicidally, mania, or psychotic decompensation.
- Evidence of a conservator of person either verbally reported by the patient or upon inspection of the medical record.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, 06516-2770
About this study
Official title: Implementing and Evaluating Computer-Based Interventions for Mental Health (CDA 14-420)
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.
Read the detailed description
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.
- Conditions
- Insomnia
- Being tested
- Internet-based Self-help Insomnia Intervention
- Keywords
- Health Technology, Internet-Based Psychotherapy, self-care, Primary Care, Mental Health
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based Self-help Insomnia InterventionBehavioural
Also called SHUTi (Sleep Health Using the Internet)
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.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1: Implementation As Usual (Implementation Through Rese | Active comparator | 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). Receives: Behavioral: Internet-based Self-help Insomnia Intervention |
| Phase 2: Primary Care Coached Digital CBTi Implementation (Im | Experimental | 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. Receives: Behavioral: Internet-based Self-help Insomnia Intervention |
| Phase 3: Primary Care Mental Health Collaborative Care Implem | Experimental | 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. Receives: Behavioral: Internet-based Self-help Insomnia Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 weeks following subject enrollment
Secondary outcomes (3)
Program Completion
Completion of all six modules of the program. The proportion of individuals completing all six modules among all individuals enrolled.
Measured: 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.
Measured: 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.
Measured: At enrollment and 10 weeks following enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study start30 May 2017
- Primary completion1 Jan 2020
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- The investigators will employ a hybrid type 3 implementation-effectiveness study design through which the investigator will primarily test the effectiveness of the experimental implementation strategy the investigators are developing and secondarily evaluate the clinical effectiveness of the internet-based self-help program for insomnia. The investigators will use a quasi-experimental pre-/post-cohort design whereby the program will initially be implemented using an enhanced usual care (control) strategy, followed by implementation using the experimental implementation strategy. The program's association with clinical response will be evaluated in an uncontrolled pre-/post-format.
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- VA Connecticut Healthcare System, US Department of Veterans Affairs
- Responsible party
- Sponsor
- Investigators
- Eric Hermes, MD, Principal investigator, VA Connecticut Healthcare System West Haven Campus, West Haven, CT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03151083
- Sponsor's protocol ID
- CDX 16-001
- Status last verified
- Jul 2023
- First submitted
- 19 Apr 2017
- Last updated
- 21 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hermes EDA, Rosenheck RA, Burrone L, Dante G, Lukens C, Martino S. The Implementation and Effectiveness of Digital Cognitive Behavioral Therapy for Insomnia in Primary Care: A Pilot Study. Implement Res Pract. 2021 Nov 15;2:26334895211053659. doi: 10.1177/26334895211053659. eCollection 2021 Jan-Dec.
PubMed 37090002
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing and Evaluating Computer-Based Interventions for Mental Health (CDA 14-420)
- ClinicalTrials.gov ID
- NCT03151083
- Acronym / sponsor ID
- CDX 16-001
- Conditions
- Insomnia
- Keywords
- Health Technology, Internet-Based Psychotherapy, self-care, Primary Care, Mental Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- VA Connecticut Healthcare System, US Department of Veterans Affairs
- Study start
- 30 May 2017 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 12 May 2017 (actual)
- Results
- Posted 27 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The investigators will employ a hybrid type 3 implementation-effectiveness study design through which the investigator will primarily test the effectiveness of the experimental implementation strategy the investigators are developing and secondarily evaluate the clinical effectiveness of the internet-based self-help program for insomnia. The investigators will use a quasi-experimental pre-/post-cohort design whereby the program will initially be implemented using an enhanced usual care (control) strategy, followed by implementation using the experimental implementation strategy. The program's association with clinical response will be evaluated in an uncontrolled pre-/post-format.
| Arm | Type | Receives |
|---|---|---|
| Phase 1: Implementation As Usual (Implementation Through Rese | Active comparator | Behavioral: Internet-based Self-help Insomnia InterventionSHUTi 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). |
| Phase 2: Primary Care Coached Digital CBTi Implementation (Im | Experimental | Behavioral: Internet-based Self-help Insomnia InterventionSHUTi 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. |
| Phase 3: Primary Care Mental Health Collaborative Care Implem | Experimental | Behavioral: Internet-based Self-help Insomnia InterventionSHUTi 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients Receiving care from a VA Connecticut West Haven PACT/PCMHI Provider
- Diagnosed with insomnia lasting 3 months by the PACT provider, as evidenced by referral by the provider for access to the SHUTiTM program
- Able to provide valid informed consent, as evidenced by answering questions indicating their understanding of the content of the Informed Consent Document
- Willing to participate in an internet-based self-help program for insomnia after the access to and requirements of the program are explained to them
- English-speaking (The SHUTiTM program is only available in English)
Key exclusion criteria (2 listed)
- Evidence of acute psychiatric decompensation requiring inpatient admission or emergency department services within the last month, including suicidality, homicidally, mania, or psychotic decompensation.
- Evidence of a conservator of person either verbally reported by the patient or upon inspection of the medical record.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-based Self-help Insomnia InterventionAlso: SHUTi (Sleep Health Using the Internet)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. | Behavioural | Phase 1: Implementation As Usual (Implementation Through Rese, Phase 2: Primary Care Coached Digital CBTi Implementation (Im, Phase 3: Primary Care Mental Health Collaborative Care Implem |
Primary outcome
Program Engagement: Completion of the First Program Module
Time frame: 3 weeks following subject enrollment
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.
3 secondary outcomes
Program Completion
Time frame: 10 Weeks following subject enrollment
Provider Adoption
Time frame: Over each 8-month active implementation Phase
Insomnia Severity Index
Time frame: At enrollment and 10 weeks following enrollment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37090002Hermes EDA, Rosenheck RA, Burrone L, Dante G, Lukens C, Martino S. The Implementation and Effectiveness of Digital Cognitive Behavioral Therapy for Insomnia in Primary Care: A Pilot Study. Implement Res Pract. 2021 Nov 15;2:26334895211053659. doi: 10.1177/26334895211053659. eCollection 2021 Jan-Dec.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Hermes, MD principal investigator
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-based Self-help Insomnia Intervention in people with Insomnia, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Program Engagement: Completion of the First Program Module (time frame: 3 weeks following subject enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03151083, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2023.