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Implementing and Sustaining a Transdiagnostic Sleep and Circadian Treatment

Primary Purpose

Sleep Disorders, Circadian Rhythm, Sleep Disorder, Acceptability

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fitted Transdiagnostic Sleep and Circadian intervention
Sponsored by
University of California, Berkeley
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Disorders, Circadian Rhythm focused on measuring Circadian rhythm disorders, Sleep disorders, Acceptability, Adaptation, Feasibility

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UC Berkeley

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fitted TranS-C

Arm Description

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

Outcomes

Primary Outcome Measures

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.
PROMIS--Sleep Disturbance (PROMIS = Patient-Reported Outcomes Information System)
Assesses sleep disturbance experienced by patients
CEQ (Treatment Evaluation Questionnaire)
Assesses patients' expectations of the treatment.

Secondary Outcome Measures

Process evaluation/qualitative interview
Assessing the clients' and therapists' opinions of the treatment
MINI
Index of psychiatric disorders

Full Information

First Posted
June 4, 2018
Last Updated
April 19, 2019
Sponsor
University of California, Berkeley
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1. Study Identification

Unique Protocol Identification Number
NCT03556878
Brief Title
Implementing and Sustaining a Transdiagnostic Sleep and Circadian Treatment
Official Title
Implementing and Sustaining a Transdiagnostic Sleep and Circadian Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
July 20, 2018 (Actual)
Primary Completion Date
December 1, 2018 (Actual)
Study Completion Date
December 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Berkeley

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disorders, Circadian Rhythm, Sleep Disorder, Acceptability, Feasibility, Adaptation, Implementation Research
Keywords
Circadian rhythm disorders, Sleep disorders, Acceptability, Adaptation, Feasibility

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fitted TranS-C
Arm Type
Experimental
Arm Description
Fitted TranS-C involves 4 x 20-30 minute sessions. It involves selected cross-cutting, core and optional modules from Standard TranS-C.
Intervention Type
Behavioral
Intervention Name(s)
Fitted Transdiagnostic Sleep and Circadian intervention
Other Intervention Name(s)
Fitted TranS-C
Intervention Description
Fitted TranS-C is an adapted version is designed to improve the fit with community needs and resources.
Primary Outcome Measure Information:
Title
The acceptability of the intervention to providers will be assessed by the 'Acceptability of Intervention Measure' (AIM)
Description
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)
Title
PROMIS--Sleep Disturbance (PROMIS = Patient-Reported Outcomes Information System)
Description
Assesses sleep disturbance experienced by patients
Time Frame
Pre-treatment and 4 weeks later (i.e. post-treatment assessment)
Title
CEQ (Treatment Evaluation Questionnaire)
Description
Assesses patients' expectations of the treatment.
Time Frame
4 weeks (i.e. post-treatment assessment)
Secondary Outcome Measure Information:
Title
Process evaluation/qualitative interview
Description
Assessing the clients' and therapists' opinions of the treatment
Time Frame
4 weeks (i.e. post-treatment assessment)
Title
MINI
Description
Index of psychiatric disorders
Time Frame
Baseline only
Other Pre-specified Outcome Measures:
Title
Referral form
Description
Assesses participant suitability for the study
Time Frame
Baseline only

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allison G Harvey, PhD
Organizational Affiliation
University of California, Berkeley
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC Berkeley
City
Berkeley
State/Province
California
ZIP/Postal Code
94702
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Implementing and Sustaining a Transdiagnostic Sleep and Circadian Treatment

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