Implementing and Sustaining a Transdiagnostic Sleep and Circadian Treatment

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'.

Study Overview

• Status: Completed
• Conditions: Sleep Disorder; Feasibility; Sleep Disorders, Circadian Rhythm; Adaptation; Acceptability; Implementation Research
• Intervention / Treatment: Behavioral: Fitted Transdiagnostic Sleep and Circadian intervention

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 Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Berkeley, California, United States, 94702
      • UC Berkeley

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Behavioral: Fitted Transdiagnostic Sleep and Circadian intervention; Fitted TranS-C is an adapted version is designed to improve the fit with community needs and resources.; Other Names: Fitted TranS-C

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 weeks (i.e. post-treatment assessment)
PROMIS--Sleep Disturbance (PROMIS = Patient-Reported Outcomes Information System)	Assesses sleep disturbance experienced by patients	Pre-treatment and 4 weeks later (i.e. post-treatment assessment)
CEQ (Treatment Evaluation Questionnaire)	Assesses patients' expectations of the treatment.	4 weeks (i.e. post-treatment assessment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Process evaluation/qualitative interview	Assessing the clients' and therapists' opinions of the treatment	4 weeks (i.e. post-treatment assessment)
MINI	Index of psychiatric disorders	Baseline only

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Referral form	Assesses participant suitability for the study	Baseline only

Collaborators and Investigators

• Sponsor: University of California, Berkeley

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 20, 2018
• Primary Completion (ACTUAL): December 1, 2018
• Study Completion (ACTUAL): December 1, 2018

Study Registration Dates

• First Submitted: June 4, 2018
• First Submitted That Met QC Criteria: June 4, 2018
• First Posted (ACTUAL): June 14, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 22, 2019
• Last Update Submitted That Met QC Criteria: April 19, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Feasibility; Sleep disorders; Acceptability; Adaptation; Circadian rhythm disorders
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Dyssomnias; Neurologic Manifestations; Occupational Diseases; Chronobiology Disorders; Disease; Sleep Wake Disorders; Parasomnias; Sleep Disorders, Circadian Rhythm
• Other Study ID Numbers: Adapted_MH105513

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No