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Trial record 32 of 200 for:    Recruiting, Not yet recruiting, Available Studies | "Mental Health"

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

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ClinicalTrials.gov Identifier: NCT03151083
Recruitment Status : Recruiting
First Posted : May 12, 2017
Last Update Posted : August 21, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Insomnia Behavioral: Internet-based Self-help Insomnia Intervention

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 116 participants
Intervention Model: Sequential Assignment
Intervention 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)
Primary Purpose: Health Services Research
Official Title: Implementing and Evaluating Computer-Based Interventions for Mental Health (CDA 14-420)
Actual Study Start Date : May 30, 2017
Estimated Primary Completion Date : January 1, 2018
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Experimental Implementation strategy
The experimental implementation strategy consists of (1) a clinical intermediary for patient support, (2) provider/staff facilitation and education to empower adoption, (3) patient education to facilitate engagement and completion, and (4) a process of stepped-care to identify and refer individuals requiring a higher level of care.
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.
Other Name: SHUTi (Sleep Health Using the Internet)


Outcome Measures

Primary Outcome Measures :
  1. Program Engagement: Completion of the first Program Module [ Time Frame: 3 weeks following subject enrollment ]
    Completion of the first module of the SHUTi(TM). 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.

  2. Program Engagement: Number of Modules completed [ Time Frame: 10 Weeks following subject enrollment ]
    The number of modules of the program completed after 10 weeks. The mean number of modules completed among all participants enrolled (Poisson mean as the distribution is expected to be non-normal, heavy skewing with large numbers of zeroes and ones).


Secondary Outcome Measures :
  1. Program Completion [ Time Frame: 10 Weeks following subject enrollment ]
    Completion of all six modules of the program. The proportion of individuals completing all six modules among all individuals enrolled.

  2. Provider Adoption [ Time Frame: over the period of time it takes to enroll all subjects in each implementation period ]
    The proportion referred to the program (whether they engaged or not) among all unique Veterans treated in VA Connecticut primary care over the respective time periods.

  3. Insomnia Severity Index [ Time Frame: At enrollment and 10 weeks following enrollment. ]
    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


Other Outcome Measures:
  1. Beck Depression Inventory [ Time Frame: At enrollment and 10 weeks following enrollment ]
    The BDI is a self-report measure of depression.

  2. Sedative-Hypnotic Medication Use [ Time Frame: At enrollment and 10 weeks following enrollment ]
    The use of sedative-hypnotics will be measured by self-report of the type and dose of specific medications used in the last week.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03151083


Contacts
Contact: Eric Hermes, MD (203) 932-5711 Eric.Hermes@va.gov
Contact: Laura Burrone, BS (203) 932-5711 ext 7914 laura.burrone@va.gov

Locations
United States, Connecticut
VA Connecticut Healthcare System West Haven Campus, West Haven, CT Recruiting
West Haven, Connecticut, United States, 06516
Contact: Fred S Wright, MD    203-937-3830    fred.wright@va.gov   
Contact: Rebecca A Czlapinski, BA MA    (203) 932-5711 ext 3357    rebecca.czlapinski@va.gov   
Sub-Investigator: Cynthia A. Brandt, MD MPH         
Principal Investigator: Eric Hermes, MD         
Sub-Investigator: Kei-Hoi Cheung, PhD         
Sub-Investigator: Robert A. Rosenheck, AB MD         
Sub-Investigator: Steve Martino, PhD         
Sponsors and Collaborators
VA Office of Research and Development
VA Connecticut Healthcare System
VISN 1 Mental Illness Research, Education, and Clinical Center
VA Pain Research, Informatics, Multimorbidities, and Education Center
Investigators
Principal Investigator: Eric Hermes, MD VA Connecticut Healthcare System West Haven Campus, West Haven, CT
More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03151083     History of Changes
Other Study ID Numbers: CDX 16-001
CDA 14-420 ( Other Grant/Funding Number: VA Health Services Research & Development )
First Posted: May 12, 2017    Key Record Dates
Last Update Posted: August 21, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
Health Technology
Internet-Based Psychotherapy
self-care
Primary Care
Mental Health