Clinical trial NCT03556878: Implementing and Sustaining a Transdiagnostic Sleep and Circadian Treatment
Official title: Implementing and Sustaining a Transdiagnostic Sleep and Circadian Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disorders, Circadian Rhythm
Sleep Disorder
Acceptability
Feasibility
Adaptation
Implementation Research
Keywords: Circadian rhythm disorders
Sleep disorders
Acceptability
Adaptation
Feasibility
Lead sponsor: University of California, Berkeley
Sponsor class: OTHER
First posted: 2018-06-14
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The acceptability of the intervention to providers will be assessed by the 'Acceptability of Intervention Measure' (AIM)
timeFrame: 4 weeks (i.e. post-treatment assessment)
measure: PROMIS--Sleep Disturbance (PROMIS = Patient-Reported Outcomes Information System)
timeFrame: Pre-treatment and 4 weeks later (i.e. post-treatment assessment)
measure: CEQ (Treatment Evaluation Questionnaire)
timeFrame: 4 weeks (i.e. post-treatment assessment)
Secondary outcomes:
measure: Process evaluation/qualitative interview
timeFrame: 4 weeks (i.e. post-treatment assessment)
measure: MINI
timeFrame: Baseline only
Other outcomes:
measure: Referral form
timeFrame: Baseline only
Locations:
city: Berkeley
country: United States
facility: UC Berkeley
state: California
Study officials:
affiliation: University of California, Berkeley
name: Allison G Harvey, PhD
role: PRINCIPAL_INVESTIGATOR
References: