Acceptability, Adaptation, Feasibility, Implementation Research, Sleep Disorder, Sleep Disorders, Circadian Rhythm
Conditions
Keywords
Circadian rhythm disorders, Sleep disorders, Acceptability, Adaptation, Feasibility
Brief 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'.
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.
Interventions
BEHAVIORALFitted Transdiagnostic Sleep and Circadian intervention
Fitted TranS-C is an adapted version is designed to improve the fit with community needs and resources.
Sponsors
University of California, Berkeley
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The acceptability of the intervention to providers will be assessed by the 'Acceptability of Intervention Measure' (AIM) | 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) | Pre-treatment and 4 weeks later (i.e. post-treatment assessment) | Assesses sleep disturbance experienced by patients |
| CEQ (Treatment Evaluation Questionnaire) | 4 weeks (i.e. post-treatment assessment) | Assesses patients' expectations of the treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Process evaluation/qualitative interview | 4 weeks (i.e. post-treatment assessment) | Assessing the clients' and therapists' opinions of the treatment |
| MINI | Baseline only | Index of psychiatric disorders |
Other
| Measure | Time frame | Description |
|---|---|---|
| Referral form | Baseline only | Assesses participant suitability for the study |
Countries
United States
Outcome results
None listed