Implementing and Sustaining a Transdiagnostic Sleep and Circadian Treatment

Not Applicable

Completed

• Conditions: Sleep Disorder; Adaptation; Feasibility; Sleep Disorders, Circadian Rhythm; Implementation Research; Acceptability
• Interventions: Behavioral: Fitted Transdiagnostic Sleep and Circadian intervention

• Registration Number: NCT03556878
• Lead Sponsor: University of California, Berkeley

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.

Study Timeline

• Study First Submitted: 2018-06-04
• Study First Submitted QC: 2018-06-04
• Study First Posted: 2018-06-14
• Study Start: 2018-07-20
• Primary Completion: 2018-12-01
• Study Completion: 2018-12-01
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-19
• Last Update Posted: 2019-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fitted TranS-C	Fitted Transdiagnostic Sleep and Circadian intervention	Fitted TranS-C involves 4 x 20-30 minute sessions. It involves selected cross-cutting, core and optional modules from Standard TranS-C.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

UC Berkeley; 🇺🇸 Berkeley, California, United States