Implementing and Sustaining a Transdiagnostic Sleep and Circadian Treatment

Sleep Disorder Clinical Trial

Official title:

Implementing and Sustaining a Transdiagnostic Sleep and Circadian Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03556878
• Other study ID #: Adapted_MH105513
• Status: Completed
• Phase: N/A
• Start date: July 20, 2018
• Est. completion date: December 1, 2018

Study information

• Verified date: April 2019
• Source: University of California, Berkeley
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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'.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 1, 2018
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acceptability
• Adaptation
• Disease
• Feasibility
• Implementation Research
• Parasomnias
• Sleep Disorder
• Sleep Disorders, Circadian Rhythm
• Sleep Wake Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	UC Berkeley	Berkeley	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Berkeley

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Referral form	Assesses participant suitability for the study	Baseline only
Primary	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)
Primary	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)
Primary	CEQ (Treatment Evaluation Questionnaire)	Assesses patients' expectations of the treatment.	4 weeks (i.e. post-treatment assessment)
Secondary	Process evaluation/qualitative interview	Assessing the clients' and therapists' opinions of the treatment	4 weeks (i.e. post-treatment assessment)
Secondary	MINI	Index of psychiatric disorders	Baseline only