Preventing Insomnia With Virtual Oneshot Therapy (PIVOT)

Henry Ford Health

Status: Active, not recruiting

Conditions: Insomnia

Treatments: Behavioral: pCBT-I

Study type: Interventional

Funder types: Other

Identifiers

NCT05523726

15827-07

Details and patient eligibility

About

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.

Full 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.

Enrollment: 280 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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280 participants in 2 patient groups

Preventative Cognitive Behavioral Therapy for Insomnia

Experimental group

Description:

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.

Treatment:

Behavioral: pCBT-I

Digital Sleep Education Control

No Intervention group

Description:

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.