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Preventing Insomnia With Virtual Oneshot Therapy (PIVOT)

Primary Purpose

Insomnia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
pCBT-I
Sponsored by
Henry Ford Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Insomnia focused on measuring Insomnia, Depression, Digital Nurse Coaching, CBT-I, preventative therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Henry Ford Columbus Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Preventative Cognitive Behavioral Therapy for Insomnia

Digital Sleep Education Control

Arm 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.

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.

Outcomes

Primary Outcome Measures

Insomnia Severity
Insomnia Severity Index Score (0 to 28; higher scores correspond to worse severity)
Depression Severity
QIDS-SR16 Score (0-27; higher scores correspond to worse severity)
Cases of DSM-5 Insomnia
Meet all DSM-5 criteria for Chronic Insomnia
Cases of Clinically Significant Depression
QIDS-SR16 score of 11 or higher

Secondary Outcome Measures

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).
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).

Full Information

First Posted
August 25, 2022
Last Updated
January 9, 2023
Sponsor
Henry Ford Health System
Collaborators
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT05523726
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
May 1, 2026 (Anticipated)
Study Completion Date
December 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System
Collaborators
University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
Keywords
Insomnia, Depression, Digital Nurse Coaching, CBT-I, preventative therapy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Random assignment into experimental and control conditions at a 1:1 ratio
Masking
Investigator
Masking Description
The principle investigator will be blind to the group assignment
Allocation
Randomized
Enrollment
280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Preventative Cognitive Behavioral Therapy for Insomnia
Arm Type
Experimental
Arm 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.
Arm Title
Digital Sleep Education Control
Arm Type
No Intervention
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
pCBT-I
Intervention Description
Telehealth coaching
Primary Outcome Measure Information:
Title
Insomnia Severity
Description
Insomnia Severity Index Score (0 to 28; higher scores correspond to worse severity)
Time Frame
up to one year post-treatment
Title
Depression Severity
Description
QIDS-SR16 Score (0-27; higher scores correspond to worse severity)
Time Frame
up to one year post-treatment
Title
Cases of DSM-5 Insomnia
Description
Meet all DSM-5 criteria for Chronic Insomnia
Time Frame
6 months post-treatment
Title
Cases of Clinically Significant Depression
Description
QIDS-SR16 score of 11 or higher
Time Frame
6-months post-treatment
Secondary Outcome Measure Information:
Title
Physical Environment
Description
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).
Time Frame
Through study completion, an average of 1 year
Title
Sociocultural Environment
Description
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).
Time Frame
Through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philip Cheng, Ph.D.
Phone
(248) 344-7361
Email
pcheng1@hfhs.org
First Name & Middle Initial & Last Name or Official Title & Degree
Alec Bayoneto, BS
Phone
2483444159
Email
abayone1@hfhs.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Cheng, Ph.D.
Organizational Affiliation
Henry Ford Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henry Ford Columbus Medical Center
City
Novi
State/Province
Michigan
ZIP/Postal Code
48377
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philip Cheng, PhD
Phone
248-344-7361
Email
pcheng1@hfhs.org
First Name & Middle Initial & Last Name & Degree
Alec Bayoneto, BS
Phone
248-344-4159
Email
abayone1@hfhs.org

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Preventing Insomnia With Virtual Oneshot Therapy (PIVOT)

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