InsomniaNCT05523726
Preventing Insomnia With Virtual Oneshot Therapy (PIVOT)
A study testing pCBT-I in people with Insomnia, run by Henry Ford Health System at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia
- What is being tested?
- pCBT-I
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2022to 13 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Henry Ford Columbus Medical Center
Novi, Michigan, 48377
About this study
Official title: Preventing Insomnia and Depression With Nurse Coaching in Individuals With Low Socioeconomic Position
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.
Read the 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.
- Conditions
- Insomnia
- Being tested
- pCBT-I
- Keywords
- Insomnia, Depression, Digital Nurse Coaching, CBT-I, preventative therapy
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pCBT-IBehavioural
Telehealth coaching
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity
Insomnia Severity Index Score (0 to 28; higher scores correspond to worse severity)
Measured: up to one year post-treatment
Depression Severity
QIDS-SR16 Score (0-27; higher scores correspond to worse severity)
Measured: up to one year post-treatment
Cases of DSM-5 Insomnia
Meet all DSM-5 criteria for Chronic Insomnia
Measured: 6 months post-treatment
Cases of Clinically Significant Depression
QIDS-SR16 score of 11 or higher
Measured: 6-months post-treatment
Secondary outcomes (2)
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).
Measured: Through study completion, an average of 1 year
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).
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study start1 Dec 2022
- Primary completion13 Mar 2026
- Study completion13 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Random assignment into experimental and control conditions at a 1:1 ratio
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan
- Responsible party
- Principal investigator, Philip Cheng, Henry Ford Health System
- Investigators
- Philip Cheng, Ph.D., Principal investigator, Henry Ford Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05523726
- Sponsor's protocol ID
- 15827-07
- Status last verified
- Mar 2026
- First submitted
- 25 Aug 2022
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Insomnia and Depression With Nurse Coaching in Individuals With Low Socioeconomic Position
- ClinicalTrials.gov ID
- NCT05523726
- Acronym / sponsor ID
- 15827-07
- Conditions
- Insomnia
- Keywords
- Insomnia, Depression, Digital Nurse Coaching, CBT-I, preventative therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Collaborators
- University of Michigan
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 13 Mar 2026 (actual)
- Study completion
- 13 Mar 2026 (actual)
- First posted
- 31 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Random assignment into experimental and control conditions at a 1:1 ratio
| Arm | Type | Receives |
|---|---|---|
| Preventative Cognitive Behavioral Therapy for Insomnia | Experimental | Behavioral: pCBT-IParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pCBT-ITelehealth coaching | Behavioural | Preventative Cognitive Behavioral Therapy for Insomnia |
Primary outcome
Insomnia Severity
Time frame: up to one year post-treatment
Insomnia Severity Index Score (0 to 28; higher scores correspond to worse severity)
Depression Severity
Time frame: up to one year post-treatment
QIDS-SR16 Score (0-27; higher scores correspond to worse severity)
Cases of DSM-5 Insomnia
Time frame: 6 months post-treatment
Meet all DSM-5 criteria for Chronic Insomnia
Cases of Clinically Significant Depression
Time frame: 6-months post-treatment
QIDS-SR16 score of 11 or higher
2 secondary outcomes
Physical Environment
Time frame: Through study completion, an average of 1 year
Sociocultural Environment
Time frame: Through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Cheng, Ph.D. principal investigator
Henry Ford Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pCBT-I in people with Insomnia, run by Henry Ford Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity (time frame: up to one year post-treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.