Clinical trial NCT05523726: Preventing Insomnia With Virtual Oneshot Therapy (PIVOT)
Official title: Preventing Insomnia and Depression With Nurse Coaching in Individuals With Low Socioeconomic Position
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Insomnia
Keywords: Insomnia
Depression
Digital Nurse Coaching
CBT-I
preventative therapy
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
Collaborators: name: University of Michigan
First posted: 2022-08-31
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Random assignment into experimental and control conditions at a 1:1 ratio
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Insomnia Severity
timeFrame: up to one year post-treatment
measure: Depression Severity
timeFrame: up to one year post-treatment
measure: Cases of DSM-5 Insomnia
timeFrame: 6 months post-treatment
measure: Cases of Clinically Significant Depression
timeFrame: 6-months post-treatment
Secondary outcomes:
measure: Physical Environment
timeFrame: Through study completion, an average of 1 year
measure: Sociocultural Environment
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Novi
country: United States
facility: Henry Ford Columbus Medical Center
state: Michigan
Study officials:
affiliation: Henry Ford Health
name: Philip Cheng, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: