Preventing Insomnia With Virtual Oneshot Therapy (PIVOT)

NCT05523726 | Completed DMC

• 1 other identifier: 15827-07
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia

Keywords

Insomnia; Depression; Digital Nurse Coaching; CBT-I; preventative therapy

Outcome Measures

Primary Outcomes (4)

• Insomnia Severity

  Insomnia Severity Index Score (0 to 28; higher scores correspond to worse severity)

  up to one year post-treatment

• Depression Severity

  QIDS-SR16 Score (0-27; higher scores correspond to worse severity)

  up to one year post-treatment

• Cases of DSM-5 Insomnia

  Meet all DSM-5 criteria for Chronic Insomnia

  6 months post-treatment

• Cases of Clinically Significant Depression

  QIDS-SR16 score of 11 or higher

  6-months post-treatment

Secondary Outcomes (2)

• Physical Environment

  Through study completion, an average of 1 year

• Sociocultural Environment

  Through study completion, an average of 1 year

Study Arms (2)

Preventative Cognitive Behavioral Therapy for Insomnia

EXPERIMENTAL

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.

Behavioral: pCBT-I

Digital Sleep Education Control

NO INTERVENTION

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.

Interventions

pCBT-I BEHAVIORAL

Telehealth coaching

Preventative Cognitive Behavioral Therapy for Insomnia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Henry Ford Health System: lead
• University of Michigan: collaborator

Study Sites (1)

Henry Ford Columbus Medical Center

Novi, Michigan, 48377, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Depression

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Philip Cheng, Ph.D.

  Henry Ford Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The principle investigator will be blind to the group assignment
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Random assignment into experimental and control conditions at a 1:1 ratio

Study Record Dates

• First Submitted: August 25, 2022
• First Posted: August 31, 2022
• Study Start: December 1, 2022
• Primary Completion: March 13, 2026
• Study Completion: March 13, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)