Implementing and Evaluating Computer-Based Interventions for Mental Health: Testing an Implementation Strategy for VA Outpatient Care

Insomnia Clinical Trial

Official title:

Implementing and Evaluating Computer-Based Interventions for Mental Health (CDA 14-420)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03151083
• Other study ID #: CDX 16-001
• Status: Completed
• Phase: N/A
• Start date: May 30, 2017
• Est. completion date: June 1, 2021

Study information

• Verified date: July 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: June 1, 2021
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Insomnia

Intervention

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.

Locations

Country	Name	City	State
United States	VA Connecticut Healthcare System West Haven Campus, West Haven, CT	West Haven	Connecticut

Sponsors (3)

Lead Sponsor	Collaborator
VA Office of Research and Development	US Department of Veterans Affairs, VA Connecticut Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	At enrollment and 10 weeks following enrollment
Other	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.	At enrollment and 10 weeks following enrollment
Primary	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.	3 weeks following subject enrollment
Secondary	Program Completion	Completion of all six modules of the program. The proportion of individuals completing all six modules among all individuals enrolled.	10 Weeks following subject enrollment
Secondary	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.	Over each 8-month active implementation Phase
Secondary	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.	At enrollment and 10 weeks following enrollment.