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Better sleep could ease severe mental illness symptoms, study finds

NCT ID NCT04154631

Symptom relief Sponsor: University of California, Berkeley Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a sleep and circadian treatment (TranS-C) for people with severe mental illness (SMI) in community mental health centers. The treatment was adapted to better fit these settings. Researchers looked at whether it improved sleep, daily functioning, and symptoms in 489 participants. The goal was to see if the adapted version works better than the standard one and if it's acceptable to providers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Behavioral sleep and circadian treatment (TranS-C)
What this could lead to
If successful, this could provide an effective, practical sleep treatment tailored for people with severe mental illness in community settings, improving daily functioning and well-being.
What could go wrong
This is an implementation study, not a test of a new drug or cure. The treatment is behavioral, so results depend on provider and patient engagement, and may not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

489 people

The number who actually took part.

Started

Jan 2020

Finished

Dec 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: The inclusion criteria for CMHCs are: * Publicly funded adult mental health outpatient services * Support from CMHC leadership The inclusion criteria for CMHC providers are: * Employed or able to deliver client-facing services to CMHC clients * Interest in learning and delivering TranS-C * Volunteer to participate and formally consent to participate Consumers must meet the following inclusion criteria: * Aged 18 years and older * Meet criteria for an SMI per self-report and confirmed by referring provider or administration of the Mini International Neuropsychiatric Interview (MINI) (DSM-5, Version 7.0.0) by a licensed clinical social worker on the research team * Exhibit a sleep or circadian disturbance as determined by endorsing 4 "quite a bit" or 5 "very much" (or the equivalent for reverse scored items) on one or more PROMIS-SD questions * Receiving the standard of care for the SMI and consent to regular communications between the research team and provider * Consent to access their medical record and participate in assessments * Guaranteed place to sleep for at least 2 months that is not a shelter Exclusion Criteria: * Presence of an active and progressive physical illness or neurological degenerative disease directly related to the onset and course of the sleep and circadian dysfunction, or making participation in the study unfeasible based on confirmation from the treating clinician and/or medical record * Presence of substance abuse/dependence only if it makes participation in the study unfeasible * Current active intent or plan to commit suicide (those with suicidal ideation are eligible) only if it makes participation in the study unfeasible, or homicide risk * Night shift work \>2 nights per week in the past 3 months * Pregnancy or breast-feeding

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Conditions

The condition(s) this trial relates to.

Chronobiology Disorders circadian rhythm sleep disorder sleep disorder sleep-wake disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Circadian dysregulation Sleep disorder

Contacts and locations

Locations

  • Alameda County Behavioral Health Care Services

    Oakland, California, 94606, United States

  • Bay Area Community Health

    San Jose, California, 95148, United States

  • Contra Costa Health, Housing, and Homeless Services Division

    Concord, California, 94520, United States

  • County of Santa Cruz Behavioral Health Services for Children and Adults

    Santa Cruz, California, 95060, United States

  • Kings County Behavioral Health

    Hanford, California, 93230, United States

  • Lake County Behavioral Health Services

    Lucerne, California, 95458, United States

  • Monterey County Behavioral Health

    Salinas, California, 93906, United States

  • Placer County Health and Human Services, Adult System of Care

    Roseville, California, 95678, United States

  • Santa Barbara County Department of Behavioral Wellness

    Goleta, California, 93110, United States

  • Solano County Department of Health & Social Services, Behavioral Health Services

    Fairfield, California, 94533, United States

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