Preventing Insomnia With Virtual Oneshot Therapy (PIVOT)

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05523726
• Other study ID #: 15827-07
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: December 1, 2026

Study information

• Verified date: January 2024
• Source: Henry Ford Health System
• Contact: Philip Cheng, Ph.D.
• Phone: (248) 344-7361
• Email: pcheng1[@]hfhs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: December 1, 2026
• Est. primary completion date: May 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• pCBT-I
Telehealth coaching

Locations

Country	Name	City	State
United States	Henry Ford Columbus Medical Center	Novi	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Henry Ford Health System	University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

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