Implementing and Sustaining a Transdiagnostic Sleep and Circadian Treatment

University of California, Berkeley21 enrolled

Overview

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'.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

Fitted Transdiagnostic Sleep and Circadian interventionBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

UC Berkeley

Berkeley, California, United States

Outcomes

Primary Outcomes

The acceptability of the intervention to providers will be assessed by the 'Acceptability of Intervention Measure' (AIM)

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.

Time frame: 4 weeks (i.e. post-treatment assessment)

PROMIS--Sleep Disturbance (PROMIS = Patient-Reported Outcomes Information System)

Assesses sleep disturbance experienced by patients

Time frame: Pre-treatment and 4 weeks later (i.e. post-treatment assessment)

CEQ (Treatment Evaluation Questionnaire)

Assesses patients' expectations of the treatment.

Time frame: 4 weeks (i.e. post-treatment assessment)

Secondary Outcomes

Process evaluation/qualitative interview

Assessing the clients' and therapists' opinions of the treatment

Time frame: 4 weeks (i.e. post-treatment assessment)

MINI

Index of psychiatric disorders

Time frame: Baseline only

Data from ClinicalTrials.gov

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