Sleep Wake DisordersNCT05956678
Implementing and Sustaining a Sleep Treatment to Improve Community Mental Health Part 3: Sustainment
A study testing Standard Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) and Adapted Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) in people with Sleep Wake Disorders and Circadian Rhythm Disorders, run by University of California, Berkeley at 10 sites in United States.
Trial summary
Research on the sustainment of implemented evidence-based psychological treatments in routine practice settings, such as community mental health centers, is limited. The goal of this study is to test sustainment predictors, mechanisms, and outcomes of the Transdiagnostic Intervention for Sleep and Circadian… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Wake Disorders, Circadian Rhythm Disorders
- What is being tested?
- Standard Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) and Adapted Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 10 sitesUnited States
- Study dates
- 1 Apr 2023to 1 Apr 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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, able to deliver, or have delivered patient-facing services to patients within a CMHC
- Have attended a TranS-C training
- CMHC site of employment has been in a period of sustainment (i.e., implementation activities have ended) for at least three months
- volunteer to participate and formally consent to participate
Who cannot join
- N/A
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Contra Costa Health, Housing, and Homeless Services Division
Concord, California, 94520
Solano County Department of Health & Social Services, Behavioral Health Services
Fairfield, California, 94533
Santa Barbara County Department of Behavioral Wellness
Goleta, California, 93110
Kings County Behavioral Health
Hanford, California, 93230
Lake County Behavioral Health Services
Lucerne, California, 95458
Alameda County Behavioral Health Care Services
Oakland, California, 94606
Placer County Health and Human Services, Adult System of Care
Roseville, California, 95678
Monterey County Behavioral Health
Salinas, California, 93906
Bay Area Community Health
San Jose, California, 95148
County of Santa Cruz Behavioral Health Services for Children and Adults
Santa Cruz, California, 95060
About this study
Research on the sustainment of implemented evidence-based psychological treatments in routine practice settings, such as community mental health centers, is limited. The goal of this study is to test sustainment predictors, mechanisms, and outcomes of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) in community mental health centers after implementation efforts have ended. CMHC providers have been trained to deliver a "Standard" or "Adapted" version of TranS-C. Researchers will compare these two groups to evaluate differences--and possible mechanisms--with respect to sustainment outcomes.
Read the detailed description
More research on the sustainment of implemented evidence-based treatments in routine practice settings, such as community mental health centers (CMHCs), is needed. This study is the third and final phase-i.e., the Sustainment Phase-of a cluster-randomized controlled trial and focuses on CMHC providers' sustainment of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C). The Sustainment Phase seeks to build on the two earlier phases of the trial-the Implementation Phase (NCT04154631) and Train-the-Trainer Phase (NCT05805657)-during which TranS-C was adapted to fit the CMHC context, and ten CMHCs were cluster-randomized to implement Standard TranS-C or Adapted TranS-C via facilitation and train-the-trainer. Data collection for the Sustainment Phase will commence at least three months after implementation efforts in partnering CMHCs have ended. Note that in this study, sustainment is operationalized per Shediac-Rizkallah and Bone's framework (1998) and defined as continued (a) activities, (b) benefits, and (c) capacity of an intervention after implementation efforts have ended.
Aim 1: Report the sustainment outcomes of TranS-C after implementation support has ended.
Aim 2: Evaluate whether manipulating fit to context predicts sustainment outcomes. It is hypothesized that providers in Adapted TranS-C will report better sustainment outcomes (i.e., activities, benefits, and capacity) relative to Standard TranS-C.
Aim 3: Test whether provider perceptions of fit-operationalized as acceptability, appropriateness, and feasibility-mediate the relation between treatment condition (Standard versus Adapted TranS-C) and sustainment outcomes. It is hypothesized that Adapted TranS-C, compared to Standard TranS-C, will predict better sustainment outcomes (i.e., activities, benefits, and capacity) indirectly through better provider perceptions of fit.
- Conditions
- Sleep Wake Disorders, Circadian Rhythm Disorders
- Being tested
- Standard Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C), Adapted Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C)
- Keywords
- Implementation, Sustainment, Evidence-based treatment, Community mental health
- Medical subject headings
- Sleep Wake Disorders, Chronobiology Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C)Behavioural
TranS-C is a psychosocial treatment designed to improve sleep and circadian functioning. It is a modular, psychosocial, skills-based approach. In this study, two version of TranS-C will be tested: Standard and Adapted.
Adapted Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C)Behavioural
The Adapted version was derived from Standard TranS-C. It was developed to improve the fit of the treatment with the CMHC context.
| Study group | Role | What they receive |
|---|---|---|
| Standard TranS-C | Experimental | Standard TranS-C is modularized and delivered across eight 50-minute, weekly, individual sessions. It is comprised of 4 cross-cutting interventions featured in every session; 4 core modules that apply to the vast majority of patients; and 7 optional modules used less commonly, depending on the presentation. Receives: Behavioral: Standard Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) |
| Adapted TranS-C | Experimental | The process for developing Adapted TranS-C has been iterative and grounded in theory, data and stakeholder feedback. The core elements of the evidence-based theory of change underpinning TranS-C have been retained. Adapted TranS-C is delivered in four 20-minute, weekly, individual sessions and is comprised of 4 cross-cutting interventions featured in every session, 5 modules that apply to the vast majority of patients, and 1 optional module used less commonly, depending on the presentation. Receives: Behavioral: Adapted Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Provider Report of Sustainment Scale
Assesses providers' continued delivery of TranS-C via three self-report items that are rated on a scale from 0 (not at all) to 4 (to a very great extent) such that higher scores indicate more sustainment.
Measured: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
Adaptations to Evidence-Based Practices Scale
Assesses provider adaptations to TranS-C via six self-report items that are rated on scale from 1 (not at all) to 4 (very great extent) such that higher scores indicate greater use of adaptations.
Measured: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
Penetration of TranS-C in Provider Caseload
Two self-report items are used to derive the proportion of eligible patients with whom the provider has used TranS-C (i.e., number of eligible patients with whom provider has used TranS-C / the number of providers' patients with sleep problems), with higher scores indicating more penetration.
Measured: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
Outcomes and Effectiveness Scale
Assesses providers' perceptions of TranS-C's health benefits using five self-report items rated on a scale from 0 (to little or no extent) to 7 (to a very great extent) such that higher scores indicate more perceived benefits.
Measured: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
Skills Subscale from the Determinants of Implementation Behavior Questionnaire
Assesses providers perceptions of their skills to deliver TranS-C using three self-report items rated on a scale from 1 (strongly disagree) to 7 (strongly agree), where higher scores indicate perceptions of greater skills.
Measured: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
Organizational Resources Subscale from the Implementation Potential Scales
Assesses providers' perceptions of whether they have the resources, support, and time needed to deliver TranS-C. Three items are rated on a scale from 1 (strongly disagree) to 6 (strongly agree), where higher ratings indicate more perceived resources, support, and time.
Measured: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
Secondary outcomes (10)
TranS-C Delivery Relative to Pre-Sustainment
Uses one self-report item to assess whether providers are using TranS-C "more" (scored as 2), "about the same" (scored as 1), or "less" (scored as 0), relative to before the Sustainment Phase.
Measured: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
TranS-C Provider Checklist
Assesses which TranS-C modules were delivered by providers during the Sustainment Phase using a self-report checklist containing all the modules for each condition. For each module, the checklist is scored such that 0 indicates that the provider did not deliver the module and 1 indicates that the provider delivered the module.
Measured: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
Adaptations Checklist from the Framework for Reporting Adaptations and Modification - Expanded
Assesses whether providers made any adaptations to TranS-C based on patient characteristics using a self-report checklist. Each patient characteristic on the checklist is scored such that 0 indicates that the provider did not make adaptations based on the characteristic and 1 indicates that the provider did make adaptations based on the characteristic.
Measured: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
Use of Provider Manual and Patient Workbook
Assesses the extent to which providers follow the TranS-C provider manual and patient workbook via one self-report item with the following scale: 0% (not at all) to 100% (always/completely).
Measured: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
Percentage of TranS-C Strategies Used
Assesses the percentage of TranS-C strategies used by providers on average when delivering TranS-C to patients via one self-report item with the following scale: 0% (no strategies) to 100% (all the strategies).
Measured: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
TranS-C as Integrated or Standalone Treatment
Assesses whether providers deliver TranS-C as a standalone intervention using one self-report item with the following 4 categorically-coded response options: I always deliver the sleep treatment as a stand-alone intervention; I sometimes integrate the sleep treatment with other interventions or topics; I always integrate the sleep treatment with other interventions or topics; not applicable.
Measured: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
Number of Sessions with TranS-C
Assesses the number of sessions in which providers use TranS-C concepts for each patient, on average, via one self-report item that ranges from 0 (no sessions) to 50 (50 sessions).
Measured: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
Creation of Sleep Treatment Materials
Assesses whether providers have created their own sleep treatment materials via one self-report item with the following categorically-coded response options: no, not relevant, yes with option to describe materials.
Measured: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
Administrator Support Subscale from the Implementation Potential Scales
Assesses the extent to which providers perceive they have support from leadership and supervisors to deliver TranS-C. Three items are rated on a scale from 1 (strongly disagree) to 6 (strongly agree), where higher scores indicate more support.
Measured: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
Knowledge of TranS-C
Assesses the extent to which providers (1) understand the theory and concepts behind TranS-C and (2) have the knowledge to conduct TranS-C. Two items are rated on a scale from 0 (not at all) to 7 (extremely), where higher scores indicate more knowledge.
Measured: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start1 Apr 2023
- Primary completion1 Apr 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sleep Wake DisordersStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- CMHC providers are cluster-randomized to either Standard TranS-C or Adapted TranS-C by their CMHC of employment.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Berkeley
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Allison Harvey, PhD, Principal investigator, University of California, BerkeleyLaurel Sarfan, PhD, Principal investigator, University of California, Berkeley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05956678
- Sponsor's protocol ID
- R01MH120147_P3
- Other IDs
- R01MH120147
- Status last verified
- May 2024
- First submitted
- 13 Jul 2023
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sarfan LD, Agnew ER, Diaz M, Cogan A, Spencer JM, Esteva Hache R, Wiltsey Stirman S, Lewis CC, Kilbourne AM, Harvey AG. The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) for serious mental illness in community mental health part 3: study protocol to evaluate sustainment in a hybrid type 2 effectiveness-implementation cluster-randomized trial. Trials. 2024 Jan 15;25(1):54. doi: 10.1186/s13063-023-07900-1.
PubMed 38225677Sarfan LD, Agnew ER, Diaz M, Cogan A, Spencer JM, Hache RE, Stirman SW, Lewis CC, Kilbourne AM, Harvey A. The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) for serious mental illness in community mental health part 3: Study protocol to evaluate sustainment in a hybrid type 2 effectiveness-implementation cluster-randomized trial. Res Sq [Preprint]. 2023 Oct 30:rs.3.rs-3328993. doi: 10.21203/rs.3.rs-3328993/v1.
PubMed 37961426
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing and Sustaining a Sleep Treatment to Improve Community Mental Health Part 3: Sustainment
- ClinicalTrials.gov ID
- NCT05956678
- Acronym / sponsor ID
- R01MH120147_P3
- Conditions
- Sleep Wake Disorders, Circadian Rhythm Disorders
- Keywords
- Implementation, Sustainment, Evidence-based treatment, Community mental health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University of California, BerkeleyUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 21 Jul 2023 (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.
Research on the sustainment of implemented evidence-based psychological treatments in routine practice settings, such as community mental health centers, is limited. The goal of this study is to test sustainment predictors, mechanisms, and outcomes of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) in community mental health centers after implementation efforts have ended. CMHC providers have been trained to deliver a "Standard" or "Adapted" version of TranS-C. Researchers will compare these two groups to evaluate differences--and possible mechanisms--with respect to sustainment outcomes.
Detailed description
More research on the sustainment of implemented evidence-based treatments in routine practice settings, such as community mental health centers (CMHCs), is needed. This study is the third and final phase-i.e., the Sustainment Phase-of a cluster-randomized controlled trial and focuses on CMHC providers' sustainment of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C). The Sustainment Phase seeks to build on the two earlier phases of the trial-the Implementation Phase (NCT04154631) and Train-the-Trainer Phase (NCT05805657)-during which TranS-C was adapted to fit the CMHC context, and ten CMHCs were cluster-randomized to implement Standard TranS-C or Adapted TranS-C via facilitation and train-the-trainer. Data collection for the Sustainment Phase will commence at least three months after implementation efforts in partnering CMHCs have ended. Note that in this study, sustainment is operationalized per Shediac-Rizkallah and Bone's framework (1998) and defined as continued (a) activities, (b) benefits, and (c) capacity of an intervention after implementation efforts have ended.
Aim 1: Report the sustainment outcomes of TranS-C after implementation support has ended.
Aim 2: Evaluate whether manipulating fit to context predicts sustainment outcomes. It is hypothesized that providers in Adapted TranS-C will report better sustainment outcomes (i.e., activities, benefits, and capacity) relative to Standard TranS-C.
Aim 3: Test whether provider perceptions of fit-operationalized as acceptability, appropriateness, and feasibility-mediate the relation between treatment condition (Standard versus Adapted TranS-C) and sustainment outcomes. It is hypothesized that Adapted TranS-C, compared to Standard TranS-C, will predict better sustainment outcomes (i.e., activities, benefits, and capacity) indirectly through better provider perceptions of fit.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- CMHC providers are cluster-randomized to either Standard TranS-C or Adapted TranS-C by their CMHC of employment.
| Arm | Type | Receives |
|---|---|---|
| Standard TranS-C | Experimental | Behavioral: Standard Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C)Standard TranS-C is modularized and delivered across eight 50-minute, weekly, individual sessions. It is comprised of 4 cross-cutting interventions featured in every session; 4 core modules that apply to the vast majority of patients; and 7 optional modules used less commonly, depending on the presentation. |
| Adapted TranS-C | Experimental | Behavioral: Adapted Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C)The process for developing Adapted TranS-C has been iterative and grounded in theory, data and stakeholder feedback. The core elements of the evidence-based theory of change underpinning TranS-C have been retained. Adapted TranS-C is delivered in four 20-minute, weekly, individual sessions and is comprised of 4 cross-cutting interventions featured in every session, 5 modules that apply to the vast majority of patients, and 1 optional module used less commonly, depending on the presentation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Publicly funded adult mental health outpatient services
- Support from CMHC leadership
- Employed, able to deliver, or have delivered patient-facing services to patients within a CMHC
- Have attended a TranS-C training
- CMHC site of employment has been in a period of sustainment (i.e., implementation activities have ended) for at least three months
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| Standard Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C)TranS-C is a psychosocial treatment designed to improve sleep and circadian functioning. It is a modular, psychosocial, skills-based approach. In this study, two version of TranS-C will be tested: Standard and Adapted. | Behavioural | Standard TranS-C |
| Adapted Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C)The Adapted version was derived from Standard TranS-C. It was developed to improve the fit of the treatment with the CMHC context. | Behavioural | Adapted TranS-C |
Primary outcome
Provider Report of Sustainment Scale
Time frame: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
Assesses providers' continued delivery of TranS-C via three self-report items that are rated on a scale from 0 (not at all) to 4 (to a very great extent) such that higher scores indicate more sustainment.
Adaptations to Evidence-Based Practices Scale
Time frame: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
Assesses provider adaptations to TranS-C via six self-report items that are rated on scale from 1 (not at all) to 4 (very great extent) such that higher scores indicate greater use of adaptations.
Penetration of TranS-C in Provider Caseload
Time frame: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
Two self-report items are used to derive the proportion of eligible patients with whom the provider has used TranS-C (i.e., number of eligible patients with whom provider has used TranS-C / the number of providers' patients with sleep problems), with higher scores indicating more penetration.
Outcomes and Effectiveness Scale
Time frame: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
Assesses providers' perceptions of TranS-C's health benefits using five self-report items rated on a scale from 0 (to little or no extent) to 7 (to a very great extent) such that higher scores indicate more perceived benefits.
Skills Subscale from the Determinants of Implementation Behavior Questionnaire
Time frame: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
Assesses providers perceptions of their skills to deliver TranS-C using three self-report items rated on a scale from 1 (strongly disagree) to 7 (strongly agree), where higher scores indicate perceptions of greater skills.
Organizational Resources Subscale from the Implementation Potential Scales
Time frame: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
Assesses providers' perceptions of whether they have the resources, support, and time needed to deliver TranS-C. Three items are rated on a scale from 1 (strongly disagree) to 6 (strongly agree), where higher ratings indicate more perceived resources, support, and time.
10 secondary outcomes
TranS-C Delivery Relative to Pre-Sustainment
Time frame: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
TranS-C Provider Checklist
Time frame: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
Adaptations Checklist from the Framework for Reporting Adaptations and Modification - Expanded
Time frame: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
Use of Provider Manual and Patient Workbook
Time frame: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
Percentage of TranS-C Strategies Used
Time frame: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
TranS-C as Integrated or Standalone Treatment
Time frame: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
Number of Sessions with TranS-C
Time frame: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
Creation of Sleep Treatment Materials
Time frame: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
Administrator Support Subscale from the Implementation Potential Scales
Time frame: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
Knowledge of TranS-C
Time frame: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
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 10 May 2024.
- Derived from this study: PubMed 38225677Sarfan LD, Agnew ER, Diaz M, Cogan A, Spencer JM, Esteva Hache R, Wiltsey Stirman S, Lewis CC, Kilbourne AM, Harvey AG. The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) for serious mental illness in community mental health part 3: study protocol to evaluate sustainment in a hybrid type 2 effectiveness-implementation cluster-randomized trial. Trials. 2024 Jan 15;25(1):54. doi: 10.1186/s13063-023-07900-1.
- Derived from this study: PubMed 37961426Sarfan LD, Agnew ER, Diaz M, Cogan A, Spencer JM, Hache RE, Stirman SW, Lewis CC, Kilbourne AM, Harvey A. The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) for serious mental illness in community mental health part 3: Study protocol to evaluate sustainment in a hybrid type 2 effectiveness-implementation cluster-randomized trial. Res Sq [Preprint]. 2023 Oct 30:rs.3.rs-3328993. doi: 10.21203/rs.3.rs-3328993/v1.
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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.
Allison Harvey, PhD principal investigator
University of California, Berkeley
Laurel Sarfan, PhD principal investigator
University of California, Berkeley
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) and Adapted Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) in people with Sleep Wake Disorders and Circadian Rhythm Disorders, run by University of California, Berkeley at 10 sites 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 8 inclusion and 1 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 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
Provider Report of Sustainment Scale (time frame: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.). The study lists 6 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 NCT05956678, which also lists 2 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 10 May 2024.