Implementing and Sustaining a Transdiagnostic Sleep and Circadian Treatment

Study Overview
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Brief Summary
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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
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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.

Official Title
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Implementing and Sustaining a Transdiagnostic Sleep and Circadian Treatment

Conditions
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Sleep Disorders, Circadian Rhythm, Sleep Disorder, Acceptability, Feasibility, Adaptation, Implementation Research

Intervention / Treatment
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* Behavioral: Fitted Transdiagnostic Sleep and Circadian intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fitted TranS-C<br>Fitted TranS-C involves 4 x 20-30 minute sessions. It involves selected cross-cutting, core and optional modules from Standard TranS-C. | Behavioral: Fitted Transdiagnostic Sleep and Circadian intervention<br>* Fitted TranS-C is an adapted version is designed to improve the fit with community needs and resources.<br>* Other names: Fitted TranS-C;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 4 weeks (i.e. post-treatment assessment) | 
| PROMIS--Sleep Disturbance (PROMIS = Patient-Reported Outcomes Information System) | Assesses sleep disturbance experienced by patients | Pre-treatment and 4 weeks later (i.e. post-treatment assessment) | 
| CEQ (Treatment Evaluation Questionnaire) | Assesses patients' expectations of the treatment. | 4 weeks (i.e. post-treatment assessment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Process evaluation/qualitative interview | Assessing the clients' and therapists' opinions of the treatment | 4 weeks (i.e. post-treatment assessment) | 
| MINI | Index of psychiatric disorders | Baseline only | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Circadian rhythm disorders, Sleep disorders, Acceptability, Adaptation, Feasibility