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Completed

NCT Number: NCT05523726

Preventing Insomnia With Virtual Oneshot Therapy (PIVOT)

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.

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Key information

Conditions

Insomnia Behavior Behavioral Symptoms Depression Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Henry Ford Columbus Medical Center

Novi, Michigan, 48377, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pCBT-I

Behavioral

Telehealth coaching

Primary outcomes

  1. Insomnia Severity

    Time frame: up to one year post-treatment

    Insomnia Severity Index Score (0 to 28; higher scores correspond to worse severity)

  2. Depression Severity

    Time frame: up to one year post-treatment

    QIDS-SR16 Score (0-27; higher scores correspond to worse severity)

  3. Cases of DSM-5 Insomnia

    Time frame: 6 months post-treatment

    Meet all DSM-5 criteria for Chronic Insomnia

  4. Cases of Clinically Significant Depression

    Time frame: 6-months post-treatment

    QIDS-SR16 score of 11 or higher

Secondary outcomes

  1. Physical Environment

    Time frame: Through study completion, an average of 1 year

    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).

  2. Sociocultural Environment

    Time frame: Through study completion, an average of 1 year

    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).

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Collaborators

  • University of Michigan

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Aug 31, 2022
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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