Preventing Insomnia With Virtual Oneshot Therapy (PIVOT)

Study Overview
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Brief Summary
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This study is intended to assess the efficacy of preventative Cognitive Behavioral Therapy for Insomnia (pCBT-I) on reducing the severity and stopping the progression of acute insomnia and depression. We also hope to gain a deeper understanding of the sociocultural, interpersonal, and individual factors that may have a role in development of insomnia and/or engagement with treatment plans.

Detailed Description
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Insomnia is a debilitating condition that escalates the risk of a myriad of disorders and is a source of significant economic burden. Insomnia takes an immense toll on individuals' physical and mental wellbeing and treating it before it can develop into chronic insomnia can save individuals untold time and money on treatment. This study is intended to assess the effects of one virtual pCBT-I session with a nurse coach on reducing the severity and stopping the progression of acute insomnia and depression. The benefits of pCBT-I have been demonstrated in prior studies but have yet to be tested on larger sample populations. Participants will be recruited from the Henry Ford Health System (HFHS) outpatient network, as well as the Medicare/Medicaid data warehouse and other community partners. Subjects will be screened to determine eligibility, and then will be randomized into one of two insomnia treatment groups (control digital sleep education and pCBT-I via telehealth coaching). Upon completion, the proposed research will not only have validated a preventative treatment for both insomnia and depression, but we will have the tools to apply it in the most effective way possible.

Official Title
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Preventing Insomnia and Depression With Nurse Coaching in Individuals With Low Socioeconomic Position

Conditions
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Insomnia

Intervention / Treatment
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* Behavioral: pCBT-I


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals with low socioeconomic position as defined by income (<35k annual household income) or education (high school diploma or less) Experiencing symptoms of prodromal acute insomnia (difficulty falling asleep, difficulty staying asleep, or problems waking up too early), along with worry or distress regarding their symptoms. Exclusion Criteria: Under the age of 18 Unwilling/unable to participate Conditions that could interfere with pCBT-I (including bipolar and seizure disorders) Untreated sleep disorders besides insomnia (e.g., sleep apnea, narcolepsy) Untreated and severe medical or psychiatric disorders

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Random assignment into experimental and control conditions at a 1:1 ratio
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Preventative Cognitive Behavioral Therapy for Insomnia<br>Participants in this group will complete daily sleep diary entries for one week, and then have a telehealth pCBT-I session with a nurse coach, where they will receive personalized sleep recommendations to improve sleep quality. | Behavioral: pCBT-I<br>* Telehealth coaching<br>|
| No Intervention: Digital Sleep Education Control<br>Participants in this group will receive digital sleep education, including tips on how to improve your sleep via interactive email. These materials are selected to help prevent chronic insomnia. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia Severity | Insomnia Severity Index Score (0 to 28; higher scores correspond to worse severity) | up to one year post-treatment | 
| Depression Severity | QIDS-SR16 Score (0-27; higher scores correspond to worse severity) | up to one year post-treatment | 
| Cases of DSM-5 Insomnia | Meet all DSM-5 criteria for Chronic Insomnia | 6 months post-treatment | 
| Cases of Clinically Significant Depression | QIDS-SR16 score of 11 or higher | 6-months post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Environment | Participants will be asked about the layout of their sleep environment as well as neighborhood characteristics. Sleep environment will be assessed using qualitative information on individual's surroundings and information such as their ability to adjust light levels, temperature, and sound. If it is easier for the individual to adjust these, then they have a better physical environment for sleep. Neighborhood characteristics will be evaluated with the Neighborhood Safety scale (scores range from 1 to 5; lower scores indicate more neighborhood safety). | Through study completion, an average of 1 year | 
| Sociocultural Environment | Sociocultural environment is measured using a household roster and the Everyday Discrimination Scale. A household roster will ask participants to report the number of individuals in the household and characterize the relationship with the participant. No summary score exists for the household roster. The Everyday Discrimination Scale measures frequency of discrimination (scores range from 10 to 60; higher scores represent more frequent experiences of discrimination). | Through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Insomnia, Digital Nurse Coaching, CBT-I, preventative therapy