A Transdiagnostic Sleep and Circadian Treatment to Improve Community SMI Outcomes

July 23, 2025 updated by: University of California, Berkeley
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
121

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Oakland, California, United States, 94605
        • Alameda Country Behavioral Health Care Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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
    • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: TranS-C
The 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.
Behavioral: Transdiagnostic Intervention for Sleep and Circadian Dysfunction
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.
Active Comparator: UC-DT
Usual 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.
Behavioral: Transdiagnostic Intervention for Sleep and Circadian Dysfunction
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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.
Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Disorder-Focused Composite Score (DSM-5)
Time Frame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
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.
Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Sleep and Circadian Function: PROMIS-Sleep Disturbance
Time Frame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
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.
Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Sleep and Circadian Function: PROMIS-Sleep-Related Impairment
Time Frame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
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.
Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Depression (QIDS)
Time Frame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup

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.
Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Substance Use (ASSIST )
Time Frame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
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.
Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Psychotic Symptoms (PSYRATS )
Time Frame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
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.
Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Means and Variability of Sleep Efficiency (Daily Sleep Diary)
Time Frame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
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.
Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Actigraphy Measured Sleep (TST)
Time Frame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
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.
Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Daytime Activity (Actigraphy)
Time Frame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
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.
Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Impairment (World Health Organization Disability Assessment Schedule 2.0)
Time Frame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
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.
Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Overall Health ('Healthy Days' Core Module)
Time Frame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
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.
Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Composite Sleep Health Score
Time Frame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup

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.
Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Means and Variability of Total Sleep Time (Daily Sleep Diary)
Time Frame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
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.
Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Means and Variability of Total Wake Time (Daily Sleep Diary)
Time Frame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
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.
Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Means and Variability of Bedtime (Daily Sleep Diary)
Time Frame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
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.
Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Means and Variability of Wake Time (Daily Sleep Diary)
Time Frame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
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.
Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Actigraphy Measured Sleep (TWT)
Time Frame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
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.
Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Diagnosis of Psychiatric Disorders (MINI International Neuropsychiatric Interview )
Time Frame: Documenting diagnosis at baseline, 10-14 weeks after the beginning of treatment, and 6-month follow-up, no change predicted
Documenting diagnosis at baseline, 10-14 weeks after the beginning of treatment, and 6-month follow-up, no change predicted
Diagnosis of Sleep Disorders (Duke Structured Interview for Sleep Disorder, DSM-V)
Time Frame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Sleep and Circadian Problems Interview
Time Frame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Insomnia Severity Index
Time Frame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Hypersomnia Severity Index
Time Frame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Therapy Process Measure
Time Frame: Administered at the end of Session 2 of treatment
Credibility Expectancy Questionnaire
Administered at the end of Session 2 of treatment
Brief Pain Inventory (Short Form)
Time Frame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month follow-up
Current symptoms of chronic pain
Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month follow-up
Clinic Staff Qualitative Assessment
Time Frame: One time at the convenience of clinic staff
Explore barriers and facilitators to implementing an evidence-based sleep treatment in a community setting
One time at the convenience of clinic staff
Client Behavior Change Interview
Time Frame: One time following the completion of the first post-treatment assessment
Exploration of barriers and facilitators to behavior change
One time following the completion of the first post-treatment assessment
Credibility Evaluation Questionnaire (CEQ)
Time Frame: Session 2 and Post treatment, which is 9-14 weeks after the beginning of treatment.
Client evaluation of treatment
Session 2 and Post treatment, which is 9-14 weeks after the beginning of treatment.
Patient Recall Task
Time Frame: Post treatment, which is 9-14 weeks after the beginning of treatment, and 6-month follow-up
Participant recall of sleep coaching treatment
Post treatment, which is 9-14 weeks after the beginning of treatment, and 6-month follow-up
Useful and Utilized Questionnaire
Time Frame: Post treatment, which is 9-14 weeks after the beginning of treatment, and at 6-month follow-up
Measure of sleep coaching elements used/useful to clients
Post treatment, which is 9-14 weeks after the beginning of treatment, and at 6-month follow-up
Treatment Adherence Rating Scale-Therapist Version
Time Frame: After each treatment session filled out by therapist (8 times)
Therapist evaluation of client adherence to treatment
After each treatment session filled out by therapist (8 times)
Height
Time Frame: Pre-treatment
To calculate BMI
Pre-treatment
Medication and Other Treatment Tracking Form
Time Frame: Stability in baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Stability in baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month followup
Additional Screen for Sleep Apnea
Time Frame: Baseline Only
Snoring, tiredness/sleepiness, observed apneas, hypertension, BMI > 35 kg/m2, age > 50 years, neck circumference > 40 cm, and male gender (STOP-BANG) Questionnaire. 8-item screen for obstructive sleep apnea.
Baseline Only
Salivary Cytokine Assay
Time Frame: Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month follow-up
Measure of cytokines present in saliva (e.g., Interleukin (IL) -1 beta, IL-6, IL-8, Tumor necrosis factor (TNF) alpha, and/or C-reactive protein (CRP)) to assess immune function
Change from baseline to post treatment, which is 9-14 weeks after the beginning of treatment, and to 6-month follow-up
Patient Learning Task (Application and Thoughts Subsections)
Time Frame: Post treatment, which is 9-14 weeks after the beginning of treatment, and at 6-month follow-up
Client feedback and application of treatment
Post treatment, which is 9-14 weeks after the beginning of treatment, and at 6-month follow-up
Body Weight
Time Frame: Pre-treatment, post treatment, which is 9-14 weeks after the beginning of treatment, and at 6-month follow-up
To calculate BMI
Pre-treatment, post treatment, which is 9-14 weeks after the beginning of treatment, and at 6-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, Berkeley

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Pittsburgh
Alameda County Behavioral Health Care Services

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Allison G Harvey, PhD, University of California, Berkeley

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 17, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 17, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 9, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 11, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 12, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R01MH105513 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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