Implementing and Sustaining a Transdiagnostic Sleep and Circadian Treatment

NCT03556878 | Completed

• 1 other identifier: Adapted_MH105513
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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'.

Conditions

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

Keywords

Circadian rhythm disorders; Sleep disorders; Acceptability; Adaptation; Feasibility

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Process evaluation/qualitative interview

  4 weeks (i.e. post-treatment assessment)

• MINI

  Baseline only

Other Outcomes (1)

• Referral form

  Baseline only

Study Arms (1)

Fitted TranS-C

EXPERIMENTAL

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

Interventions

Fitted Transdiagnostic Sleep and Circadian intervention BEHAVIORAL

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

Also known as: Fitted TranS-C

Fitted TranS-C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Berkeley: lead

Study Sites (1)

UC Berkeley

Berkeley, California, 94702, United States

Location

MeSH Terms

Conditions

Sleep Disorders, Circadian Rhythm; Sleep Wake Disorders; Chronobiology Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases; Dyssomnias; Occupational Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Allison G Harvey, PhD

  University of California, Berkeley

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 4, 2018
• First Posted: June 14, 2018
• Study Start: July 20, 2018
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: April 22, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)