Sleep Disorders, Circadian RhythmNCT03556878
Implementing and Sustaining a Transdiagnostic Sleep and Circadian Treatment
A study testing Fitted Transdiagnostic Sleep and Circadian intervention in people with Sleep Disorders, Circadian Rhythm and Sleep Disorder, run by University of California, Berkeley at 1 site in United States.
Trial summary
The goal is to collect pilot data on an adapted version of the Transdiagnostic Sleep and Circadian intervention (TranS-C), referred to as 'Fitted TranS-C'. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Disorders, Circadian Rhythm, Sleep Disorder, Acceptability
- What is being tested?
- Fitted Transdiagnostic Sleep and Circadian intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2018to 1 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Can understand treatment in English
- Is not currently at risk for suicide or homicide
- Has not worked the night shift more than 2 nights per week in the past 3 months
- Is not pregnant or nursing
- Has a guaranteed bed to sleep in for the next month, which is not a shelter.
Who cannot join
- At risk for suicide or homicide
- Has worked the night shift more than 2 nights per week in the past 3 months
- Is pregnant or nursing
- Does not have a guaranteed bed to sleep in for the next month
Trial locations and contacts
1 site in 1 country.
About this study
The goal is to collect pilot data on an adapted version of the Transdiagnostic Sleep and Circadian intervention (TranS-C), referred to as 'Fitted TranS-C'.
Read the detailed description
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 collect pilot data on an adapted version of the Transdiagnostic Sleep and Circadian intervention (TranS-C). The adapted version will be referred to as 'Fitted TranS-C' as it is designed to improve the fit to delivery within community mental health centers. 'Fitted' treatments are needed because the context for implementation (community setting) typically differs from the original testing context (university setting) causing a lack of 'fit' between the setting and evidence based treatments.
- Conditions
- Sleep Disorders, Circadian Rhythm, Sleep Disorder, Acceptability, Feasibility, Adaptation, Implementation Research
- Being tested
- Fitted Transdiagnostic Sleep and Circadian intervention
- Keywords
- Circadian rhythm disorders, Sleep disorders, Acceptability, Adaptation, Feasibility
- Medical subject headings
- Sleep Disorders, Circadian Rhythm, Sleep Wake Disorders, Chronobiology Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fitted Transdiagnostic Sleep and Circadian interventionBehavioural
Also called Fitted TranS-C
Fitted TranS-C is an adapted version is designed to improve the fit with community needs and resources.
| Study group | Role | What they receive |
|---|---|---|
| Fitted TranS-C | Experimental | Fitted TranS-C involves 4 x 20-30 minute sessions. It involves selected cross-cutting, core and optional modules from Standard TranS-C. Receives: Behavioral: Fitted Transdiagnostic Sleep and Circadian intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The acceptability of the intervention to providers will be assessed by the 'Acceptability of Intervention Measure' (AIM)
The AIM is a measure of the extent to which the intervention is acceptable to providers. The AIM is comprised of 4 questions rated on a 1 'completely disagree' to 5 'completely agree' scale. The responses to all four qus will be reported along with the summed total score.
Measured: 4 weeks (i.e. post-treatment assessment)
PROMIS--Sleep Disturbance (PROMIS = Patient-Reported Outcomes Information System)
Assesses sleep disturbance experienced by patients
Measured: Pre-treatment and 4 weeks later (i.e. post-treatment assessment)
CEQ (Treatment Evaluation Questionnaire)
Assesses patients' expectations of the treatment.
Measured: 4 weeks (i.e. post-treatment assessment)
Secondary outcomes (2)
Process evaluation/qualitative interview
Assessing the clients' and therapists' opinions of the treatment
Measured: 4 weeks (i.e. post-treatment assessment)
MINI
Index of psychiatric disorders
Measured: Baseline only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2018
- Study start20 Jul 2018
- Primary completion1 Dec 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Disorders, Circadian RhythmStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a 'treatment development' pilot study in which we intended to continue to develop and adapted 'Fitted TranS-C' as we gain experience. At the outset of the study, it involves 4 x 20-30 minute sessions. It utilizes four cross-cutting, 3 core and 1 optional modules from Standard TranS-C. All participants will get the same Fitted Trans-C.
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Berkeley
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Allison G Harvey, PhD, Principal investigator, University of California, Berkeley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03556878
- Sponsor's protocol ID
- Adapted_MH105513
- Status last verified
- Apr 2019
- First submitted
- 4 Jun 2018
- Last updated
- 22 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing and Sustaining a Transdiagnostic Sleep and Circadian Treatment
- ClinicalTrials.gov ID
- NCT03556878
- Acronym / sponsor ID
- Adapted_MH105513
- Conditions
- Sleep Disorders, Circadian Rhythm, Sleep Disorder, Acceptability, Feasibility, Adaptation, Implementation Research
- Keywords
- Circadian rhythm disorders, Sleep disorders, Acceptability, Adaptation, Feasibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of California, BerkeleyUniversity, hospital or other
- Study start
- 20 Jul 2018 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 14 Jun 2018 (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.
The goal is to collect pilot data on an adapted version of the Transdiagnostic Sleep and Circadian intervention (TranS-C), referred to as 'Fitted TranS-C'.
Detailed description
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 collect pilot data on an adapted version of the Transdiagnostic Sleep and Circadian intervention (TranS-C). The adapted version will be referred to as 'Fitted TranS-C' as it is designed to improve the fit to delivery within community mental health centers. 'Fitted' treatments are needed because the context for implementation (community setting) typically differs from the original testing context (university setting) causing a lack of 'fit' between the setting and evidence based treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a 'treatment development' pilot study in which we intended to continue to develop and adapted 'Fitted TranS-C' as we gain experience. At the outset of the study, it involves 4 x 20-30 minute sessions. It utilizes four cross-cutting, 3 core and 1 optional modules from Standard TranS-C. All participants will get the same Fitted Trans-C.
| Arm | Type | Receives |
|---|---|---|
| Fitted TranS-C | Experimental | Behavioral: Fitted Transdiagnostic Sleep and Circadian interventionFitted TranS-C involves 4 x 20-30 minute sessions. It involves selected cross-cutting, core and optional modules from Standard TranS-C. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Can understand treatment in English
- Is not currently at risk for suicide or homicide
- Has not worked the night shift more than 2 nights per week in the past 3 months
- Is not pregnant or nursing
- Has a guaranteed bed to sleep in for the next month, which is not a shelter.
Key exclusion criteria (4 listed)
- At risk for suicide or homicide
- Has worked the night shift more than 2 nights per week in the past 3 months
- Is pregnant or nursing
- Does not have a guaranteed bed to sleep in for the next month
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 |
|---|---|---|
| Fitted Transdiagnostic Sleep and Circadian interventionAlso: Fitted TranS-CFitted TranS-C is an adapted version is designed to improve the fit with community needs and resources. | Behavioural | Fitted TranS-C |
Primary outcome
The acceptability of the intervention to providers will be assessed by the 'Acceptability of Intervention Measure' (AIM)
Time frame: 4 weeks (i.e. post-treatment assessment)
The AIM is a measure of the extent to which the intervention is acceptable to providers. The AIM is comprised of 4 questions rated on a 1 'completely disagree' to 5 'completely agree' scale. The responses to all four qus will be reported along with the summed total score.
PROMIS--Sleep Disturbance (PROMIS = Patient-Reported Outcomes Information System)
Time frame: Pre-treatment and 4 weeks later (i.e. post-treatment assessment)
Assesses sleep disturbance experienced by patients
CEQ (Treatment Evaluation Questionnaire)
Time frame: 4 weeks (i.e. post-treatment assessment)
Assesses patients' expectations of the treatment.
2 secondary outcomes
Process evaluation/qualitative interview
Time frame: 4 weeks (i.e. post-treatment assessment)
MINI
Time frame: Baseline only
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 22 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allison G Harvey, PhD principal investigator
University of California, Berkeley
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fitted Transdiagnostic Sleep and Circadian intervention in people with Sleep Disorders, Circadian Rhythm and Sleep Disorder, 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 5 inclusion and 4 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 22 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The acceptability of the intervention to providers will be assessed by the 'Acceptability of Intervention Measure' (AIM) (time frame: 4 weeks (i.e. post-treatment assessment)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2019.