Skip to main content
Clinical Trials/NCT03556878
NCT03556878
Completed
Not Applicable

Implementing and Sustaining a Transdiagnostic Sleep and Circadian Treatment

University of California, Berkeley1 site in 1 country21 target enrollmentJuly 20, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sleep Disorders, Circadian Rhythm
Sponsor
University of California, Berkeley
Enrollment
21
Locations
1
Primary Endpoint
The acceptability of the intervention to providers will be assessed by the 'Acceptability of Intervention Measure' (AIM)
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 20, 2018
End Date
December 1, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Process evaluation/qualitative interview(4 weeks (i.e. post-treatment assessment))
  • MINI(Baseline only)

Study Sites (1)

Loading locations...

Similar Trials