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

NCT03151083 | Completed Results

• 1 other identifier: CDX 16-001
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Insomnia

Keywords

Health Technology; Internet-Based Psychotherapy; self-care; Primary Care; Mental Health

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Program Completion

  10 Weeks following subject enrollment

• Provider Adoption

  Over each 8-month active implementation Phase

• Insomnia Severity Index

  At enrollment and 10 weeks following enrollment.

Other Outcomes (2)

• Beck Depression Inventory

  At enrollment and 10 weeks following enrollment

• Sedative-Hypnotic Medication Use

  At enrollment and 10 weeks following enrollment

Study Arms (3)

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).

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.

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.

Behavioral: Internet-based Self-help Insomnia Intervention

Interventions

Internet-based Self-help Insomnia Intervention BEHAVIORAL

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)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead
• VA Connecticut Healthcare System: collaborator
• US Department of Veterans Affairs: collaborator

Study Sites (1)

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

West Haven, Connecticut, 06516-2770, United States

Location

Related Publications (1)

• 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.

  PMID: 37090002 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Personal Satisfaction; Behavior

Limitations and Caveats

The research team realized that implementation in phase 2 was not resulting in improved implementation outcomes over phase 1. Formative evaluation of implementation took place, and and additional implementation phase (phase 3) was added.

Results Point of Contact

• Title: Dr. Eric Hermes
• Organization: VA Connecticut Healthcare System

eric.hermes@va.gov

203 932 5711

Study Officials

• Eric Hermes, MD

  VA Connecticut Healthcare System West Haven Campus, West Haven, CT

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 19, 2017
• First Posted: May 12, 2017
• Study Start: May 30, 2017
• Primary Completion: January 1, 2020
• Study Completion: June 1, 2021
• Last Updated: July 21, 2023
• Results First Posted: January 27, 2021

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)