Preventing Insomnia With Virtual Oneshot Therapy (PIVOT)

Last updated: May 12, 2025
Sponsor: Henry Ford Health System
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Insomnia

Treatment

pCBT-I

Clinical Study ID

NCT05523726
15827-07
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Individuals with low socioeconomic position as defined by income (<35k annualhousehold 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 ordistress regarding their symptoms.

Exclusion

Exclusion Criteria:

  • Under the age of 18

  • Unwilling/unable to participate

  • Conditions that could interfere with pCBT-I (including bipolar and seizuredisorders)

  • Untreated sleep disorders besides insomnia (e.g., sleep apnea, narcolepsy)

  • Untreated and severe medical or psychiatric disorders

Study Design

Total Participants: 280
Treatment Group(s): 1
Primary Treatment: pCBT-I
Phase:
Study Start date:
December 01, 2022
Estimated Completion Date:
December 01, 2026

Study Description

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.

Connect with a study center

  • Henry Ford Columbus Medical Center

    Novi, Michigan 48377
    United States

    Site Not Available

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