Implementing and Sustaining a Transdiagnostic Sleep and Circadian Treatment

NCT ID: NCT03556878

Last Updated: 2019-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-20

Study Completion Date

2018-12-01

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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fitted TranS-C

Fitted TranS-C involves 4 x 20-30 minute sessions. It involves selected cross-cutting, core and optional modules from Standard TranS-C.

Group Type EXPERIMENTAL

Fitted Transdiagnostic Sleep and Circadian intervention

Intervention Type BEHAVIORAL

Fitted TranS-C is an adapted version is designed to improve the fit with community needs and resources.

Interventions

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Fitted Transdiagnostic Sleep and Circadian intervention

Fitted TranS-C is an adapted version is designed to improve the fit with community needs and resources.

Intervention Type BEHAVIORAL

Other Intervention Names

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Fitted TranS-C

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Berkeley

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Allison G Harvey, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Berkeley

Locations

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UC Berkeley

Berkeley, California, United States

Site Status

Countries

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United States

Other Identifiers

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Adapted_MH105513

Identifier Type: -

Identifier Source: org_study_id

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