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Mental DisordersNCT02469233

A Transdiagnostic Sleep and Circadian Treatment to Improve Community SMI Outcomes

A study testing Transdiagnostic Intervention for Sleep and Circadian Dysfunction in people with Mental Disorders, run by University of California, Berkeley at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Mental illness is often severe, chronic and difficult to treat. The sleep disturbance commonly experienced by individuals with a severe mental illness reduces capacity to function and contributes to key symptoms. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mental Disorders
What is being tested?
Transdiagnostic Intervention for Sleep and Circadian Dysfunction
Could I receive a placebo?
No, everyone receives an active treatment
How many people
121 participants
Where
1 siteUnited States
Study dates
May 2015to 17 Apr 2019
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Age 18+ years
  • English language fluency
  • Presence of at least one DSM-V mental disorder for 12 months
  • One or more of the following sleep or circadian problems for 3 month as assessed with the Sleep and Circadian Problems Interview:
  • ≥30 mins to get to sleep , 3 or more nights per week
  • Waking in the middle of the night for ≥30 minutes, 3 or more nights per week
Show all 12Show fewer
  • Obtaining less than 6 hours of sleep per night, 3 or more nights per week
  • Obtaining more than 9 hours of sleep per 24 hour period (i.e., nighttime sleep plus daytime napping), 3 or more nights per week
  • More than 2.78 hours of variability in sleep-wake schedule across one week
  • Bedtime later than 2 am, 3 or more nights per week
  • Guaranteed bed to sleep in for the duration of the treatment phase
  • Receiving care for SMI at ACBHCS and consent to regular communications between research team and psychiatrist and/or case manager

Who cannot join

  • Presence of an active and progressive physical illness or neurological degenerative disease AND/OR substance abuse/dependence making participation in the study unfeasible.
  • Current serious suicide risk (assessed by our staff, a case manager or psychiatrist) or homicide risk (assessed by our staff, a case manager or psychiatrist)
  • Night shift work >2 nights per week in the past 3 months
  • Pregnancy or breast-feeding
  • Not able/willing to participate in and/or complete the pre-treatment assessments

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Alameda Country Behavioral Health Care Services

    Oakland, California, 94605

Other trials in United States

About this study

Mental illness is often severe, chronic and difficult to treat. The sleep disturbance commonly experienced by individuals with a severe mental illness reduces capacity to function and contributes to key symptoms. This study seeks to determine if an intervention to improve sleep can improve functioning and reduce symptoms and impairment. The investigators will conduct this study in community mental health centers to ensure that the results contribute to closing the worrisome gap between research and practice and to ensure that the findings are generalizable to the real world.

Read the detailed description

Despite advances in treatment, severe mental illness (SMI) remains common, chronic and difficult to treat. SMI is defined as having at least one mental disorder that lasts for 12-months and leads to substantial life interference. Sleep and circadian dysfunctions are among the most prominent correlates of SMI, yet have been minimally studied in ways that reflect the complexity of the sleep problems experienced by people with SMI. In SMI, sleep and circadian dysfunction undermines affect regulation, cognitive function and physical health, predicts onset and worsening of symptoms and is often chronic even with evidence-based SMI treatment. Prior treatment studies have been disorder-focused-they have treated a specific sleep problem (e.g., insomnia) in a specific diagnostic group (e.g., depression). However, real life sleep and circadian problems are not so neatly categorized, particularly in SMI where features of insomnia overlap with hypersomnia, delayed sleep phase and irregular sleep-wake schedules. Accordingly, the investigators aim to test the hypothesis that a Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) will improve functional impairment, disorder-focused symptoms and sleep and circadian functioning. The investigators will recruit participants across Diagnostic and Statistical Manual of Mental Disorders (DSM) diagnoses and across common sleep and circadian problems. The elements of TranS-C are efficacious across SMI in research settings with research-based providers. The next step is to test TranS-C in community settings with community-based providers. Accordingly, the investigators propose to conduct an 'efficacy in the real world' randomized controlled trial within Alameda County Behavioral Health Care Services (ACBHCS), the community mental health center (CMHC) for Alameda County. The investigators will recruit 120 adults diagnosed with SMI and sleep and circadian dysfunction within ACBHCS. Individuals will be randomly allocated to TranS-C (n = 60) or 6-months of Usual Care followed by Delayed Treatment with TranS-C (UC-DT; n = 60). TranS-C is modularized and delivered across eight to twelve 50-minute, weekly, individual sessions. All participants will be assessed before, immediately following treatment (ie. 9-14 weeks later) and again 6 months later.

Being tested
Transdiagnostic Intervention for Sleep and Circadian Dysfunction
Medical subject headings
Mental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transdiagnostic Intervention for Sleep and Circadian DysfunctionBehavioural

    The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.

Study groups in NCT02469233
Study groupRoleWhat they receive
TranS-CExperimentalThe Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) is comprised of cross-cutting interventions, 'core modules' and 'optional modules'. TranS-C is derived and adapted from our previous disorder-focused research, firmly grounded in basic science and treatment literature.
Receives: Behavioral: Transdiagnostic Intervention for Sleep and Circadian Dysfunction
UC-DTActive comparatorUsual Care, Delayed Treatment (DT) is comprised of a case manager who co-ordinates care and refers each client for a medication review and to rehabilitation programs. At the end of 6-months in UC-DT, the participants will receive TranS-C.
Receives: Behavioral: Transdiagnostic Intervention for Sleep and Circadian Dysfunction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Impairment (Sheehan Disability Scale)

    Sheehan Disability Scale (SDS) (sleep). 3-item. The SDS evaluates the extent to which work/school, social life, and home/ family responsibilities are impaired on a 0-10 (not at all to extremely) scale. The 3-items are summed to compute the total score and assess global functional impairment. Scores can range from 0 to 30, with higher values indicating higher impairment.

    Measured: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup

  2. Disorder-Focused Composite Score (DSM-5)

    DSM-5 Cross Cutting Measure. 23-items. Individuals report how much each domain has bothered them in the last 2 weeks on a 0-4 scale (not at all to nearly every day). The total score is calculated by summing the highest score in each of the 13 domains (depression, anger, mania, anxiety, somatic symptoms, suicidal ideation, psychosis, sleep problems, memory, repetitive thoughts and behaviors, dissociation, personality functioning, and substance use). Total scores can range from 0 to 52, with higher scores indicating greater severity of impairment. is rated on a 5-point scale, with higher scores indicating more severe impairment.

    Measured: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup

  3. Sleep and Circadian Function: PROMIS-Sleep Disturbance

    PROMIS-Sleep Disturbance (PROMIS = Patient-Reported Outcomes Measurement Information System). The 8-item short version assesses sleep disturbance over the past 7 days, including restlessness, sleep quality, ability to fall and stay asleep, and refreshment following sleep using a 1-5 scale (not at all or never to very much or always). Scores range from 8 to 40, with higher scores indicating increased disturbance.

    Measured: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup

  4. Sleep and Circadian Function: PROMIS-Sleep-Related Impairment

    PROMIS-Sleep-Related Impairment (PROMIS = Patient-Reported Outcomes Measurement Information System). 16-item. Scores range from 16 to 80, with higher scores indicating increased disturbance.

    Measured: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup

Secondary outcomes (14)
  1. Depression (QIDS)

    QIDS (Quick Inventory of Depressive Symptoms). 16-item instrument assessing depressive symptoms. Each item is rated on a 4-point scale (0-3), with higher scores indicating greater symptom severity.

    Scoring involves summing the highest score from each of the 9 DSM-IV Major Depressive Disorder symptom domains (sleep, weight, psychomotor changes, depressed mood, decreased interest, fatigue, guilt, concentration, and suicidal ideation). Total scores range from 0 (Normal/No Depression) to 27 (Very Severe Depression). Higher scores indicate greater severity of depressive symptoms.

    Measured: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup

  2. Substance Use (ASSIST )

    ASSIST (Alcohol, Smoking and Substance Involvement Screening Test). Frequency of use, substance dependence, and related health, social, legal, financial, and employment problems in the past 3 months are rated on a 5-point scale (never to daily of almost daily). Problems with family and friends caused by substance use and failed attempts to cut down or quit substance use are measured on a 3-point scale (no, never, yes, in the past 3 months, yes, but not in the past 3 months). The total risk score is calculated by summing scores across all drug categories, with total scores ranging from 0 to 414. Higher scores indicate greater substance-related risks and problems.

    Measured: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup

  3. Psychotic Symptoms (PSYRATS )

    PSYRATS (Psychotic Symptom Rating Scales). Each of the 17 items is rated on a 5-point scale from 0 (absent) to 4 (severe). Scores are summed for auditory hallucinations (sum of 11 items) and delusions (sum of 6 items). Total scores range from 0 to 68, with higher scores indicating greater severity of psychotic symptoms.

    Measured: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup

  4. Means and Variability of Sleep Efficiency (Daily Sleep Diary)

    Sleep efficiency (SE), calculated as total sleep time divided by time in bed, multiplied by 100, was recorded via sleep diary over 7 consecutive days. For each participant, the mean and within-person standard deviation (SD) of SE were calculated across the days to reflect an average and night-to-night variability. Group-level outcomes reflect the average of these participant-level means and SDs.

    Measured: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup

  5. Actigraphy Measured Sleep (TST)

    Actigraphy-derived total sleep time (TST) is the total amount of sleep obtained by the participant per 24 hrs, which was recorded daily over a 1-week period per timepoint. For each participant, the mean and standard deviation (SD) of TST were calculated across the days. Group-level outcomes reflect the average of these participant-level means and SDs.

    Measured: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup

  6. Daytime Activity (Actigraphy)

    Daytime activity was measured via actigraphy over 7 consecutive days per timepoint. For each participant, their daily waking activity counts were extracted, and the mean and within-person standard deviation (SD) of these counts were calculated across 7 days. Group-level outcomes reflect the average of these participant-level means and SDs.

    Measured: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup

  7. Impairment (World Health Organization Disability Assessment Schedule 2.0)

    World Health Organization Disability Assessment Schedule 2.0 (WHODAS-2.0). 36-item measure that assesses disability in adults ages 18 years and older. It assesses disability across six domains on a scale from 1-5 (none to extreme or cannot do). Each item on the self-administered version of the WHODAS-2.0 asks the individual to rate how much difficulty he or she has had in specific areas of functioning during the past 30 days. Scores are summed across the six domains (cognition, mobility, self-care, getting along, life activities, and participation). Total scores range from 36 to 180, with higher scores indicating greater levels of disability.

    Measured: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup

  8. Overall Health ('Healthy Days' Core Module)

    Four question 'healthy days' core module developed by the Centers for Disease Control and Prevention. A summary measure combines physically and mentally unhealthy days. An "unhealthy days" summary measure based on the second and third questions and estimates the overall number of recent days (in the past 30 days) when physical or mental health was not good.

    Measured: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup

  9. Composite Sleep Health Score

    Composite Sleep Health Score is defined as the sum of scores on 6 sleep health dimensions: Regularity (Midpoint sleep fluctuation across a 7-day sleep diary < 1 hour), Satisfaction (Sleep quality question on PROMIS-Sleep Disturbance (PROMIS = Patient-Reported Outcomes Measurement Information System)), Alertness (Daytime sleepiness question on PROMIS-Sleep Related Impairment (PROMIS = Patient-Reported Outcomes Measurement Information System)), Timing (Mean midpoint sleep across the 7 day sleep diary between 2 and 4 AM), Efficiency (Average sleep efficiency based on the 7 day sleep diary ≥ 85%), and Duration (Total Sleep Time average based on 7 day sleep diary between 7 and 9 hours).

    Each dimension was dichotomized such that 1 = good /yes; 0 = poor/no). Total composite sleep health score ranges from 0 to 6, with larger values indicating better sleep health.

    Measured: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup

  10. Means and Variability of Total Sleep Time (Daily Sleep Diary)

    Total sleep time (TST), measured as the total amount of sleep obtained by the participant, was reported via sleep diary over 7 consecutive days. Each participant's mean and within-person SD of TST were calculated to assess typical sleep duration and night-to-night variability. Group-level outcomes reflect the average of these participant-level means and SDs.

    Measured: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup

  11. Means and Variability of Total Wake Time (Daily Sleep Diary)

    Total wake time (TWT), measured as minutes of wakefulness within a sleep period, was reported via sleep diary over 7 consecutive days. Each participant's mean and within-person SD of their TWT were calculated across days to assess means and night-to-night variability. Group-level outcomes reflect the average of these participant-level means and SDs.

    Measured: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup

  12. Means and Variability of Bedtime (Daily Sleep Diary)

    Bedtime was reported via a 7-day daily sleep diary using a 24-hour decimal format, where times after midnight are expressed as numbers above 24 (ex. 1:30 am is 25.50). Each participant's mean and within-person SD of bedtime across 7 days were computed to capture average bedtime and variability. Group-level outcomes reflect the average of these participant-level means and SDs.

    Measured: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup

  13. Means and Variability of Wake Time (Daily Sleep Diary)

    Wake times, using a 24-hour decimal format, were reported daily across 7 days. The mean and within-person SD were calculated for each participant's wake time across days. Group-level outcomes reflect the average of these participant-level means and SDs.

    Measured: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup

  14. Actigraphy Measured Sleep (TWT)

    Actigraphy-derived total wake time (TWT), measured as minutes of wakefulness within a sleep period, was collected daily over a 1-week period. Each participant's mean and within-person SD were calculated across the 7 days. Group-level outcomes reflect the average of these participant-level means and SDs.

    Measured: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2015 (estimated)
  2. Study startMay 2015
  3. Primary completion17 Apr 2019
  4. Study completion17 Apr 2019

Resources

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
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
121 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02469233
Sponsor's protocol ID
R01MH105513
Status last verified
Jul 2025
First submitted
9 Jun 2015
Last updated
12 Aug 2025
Data monitoring committee
Yes

Publications

  • Callaway CA, Sarfan LD, Gumport NB, Harvey AG. The impact of module dosage on treatment response in a modular transdiagnostic intervention for sleep and circadian dysfunction (TranS-C). Behav Res Ther. 2023 Sep;168:104368. doi: 10.1016/j.brat.2023.104368. Epub 2023 Jul 5.

    PubMed 37478529
  • Harvey AG, Dong L, Hein K, Yu SH, Martinez AJ, Gumport NB, Smith FL, Chapman A, Lisman M, Mirzadegan IA, Mullin AC, Fine E, Dolsen EA, Gasperetti CE, Bukosky J, Alvarado-Martinez CG, Kilbourne AM, Rabe-Hesketh S, Buysse DJ. A randomized controlled trial of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) to improve serious mental illness outcomes in a community setting. J Consult Clin Psychol. 2021 Jun;89(6):537-550. doi: 10.1037/ccp0000650.

    PubMed 34264701
  • Gumport NB, Yu SH, Harvey AG. Implementing a transdiagnostic sleep and circadian intervention in a community mental health setting: A qualitative process evaluation with community stakeholders. Psychiatry Res. 2020 Nov;293:113443. doi: 10.1016/j.psychres.2020.113443. Epub 2020 Aug 31.

    PubMed 32890862
  • Harvey AG, Hein K, Dong L, Smith FL, Lisman M, Yu S, Rabe-Hesketh S, Buysse DJ. A transdiagnostic sleep and circadian treatment to improve severe mental illness outcomes in a community setting: study protocol for a randomized controlled trial. Trials. 2016 Dec 20;17(1):606. doi: 10.1186/s13063-016-1690-9.

    PubMed 27998295

Questions about this trial

What is this clinical trial studying?

A study testing Transdiagnostic Intervention for Sleep and Circadian Dysfunction in people with Mental Disorders, run by University of California, Berkeley 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 12 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 12 Aug 2025. 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?

Yes. Results are posted in the registry (first posted 12 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Impairment (Sheehan Disability Scale) (time frame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup). 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?

On the ClinicalTrials.gov record for NCT02469233, which also lists 4 linked publications.

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 12 Aug 2025.

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Clinical Trial NCT02469233 | AzTrials