Implementing and Sustaining a Transdiagnostic Sleep and Circadian Treatment

• ClinicalTrials.gov Identifier: NCT03556878
• Recruitment Status: Completed
• First Posted: June 14, 2018
• Last Update Posted: April 22, 2019
• Sponsor: University of California, Berkeley
• Information provided by (Responsible Party): University of California, Berkeley

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'.

Condition or disease	Intervention/treatment	Phase
Sleep Disorders, Circadian Rhythm; Sleep Disorder; Acceptability; Feasibility; Adaptation; Implementation Research	Behavioral: Fitted Transdiagnostic Sleep and Circadian intervention	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 21 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention 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)
• Primary Purpose: Treatment
• Official Title: Implementing and Sustaining a Transdiagnostic Sleep and Circadian Treatment
• Actual Study Start Date: July 20, 2018
• Actual Primary Completion Date: December 1, 2018
• Actual Study Completion Date: December 1, 2018

Arms and Interventions

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 Name: Fitted TranS-C

Outcome Measures

Primary Outcome Measures :

1. The acceptability of the intervention to providers will be assessed by the 'Acceptability of Intervention Measure' (AIM) [ Time Frame: 4 weeks (i.e. post-treatment assessment) ]
   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.
2. PROMIS--Sleep Disturbance (PROMIS = Patient-Reported Outcomes Information System) [ Time Frame: Pre-treatment and 4 weeks later (i.e. post-treatment assessment) ]
   Assesses sleep disturbance experienced by patients
3. CEQ (Treatment Evaluation Questionnaire) [ Time Frame: 4 weeks (i.e. post-treatment assessment) ]
   Assesses patients' expectations of the treatment.

Secondary Outcome Measures :

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

Other Outcome Measures:

1. Referral form [ Time Frame: Baseline only ]
   Assesses participant suitability for the study

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, California

UC Berkeley

Berkeley, California, United States, 94702

Sponsors and Collaborators

University of California, Berkeley

Investigators

• Principal Investigator: Allison G Harvey, PhD; University of California, Berkeley

More Information

• Responsible Party: University of California, Berkeley
• ClinicalTrials.gov Identifier: NCT03556878
• Other Study ID Numbers: Adapted_MH105513
• First Posted: June 14, 2018
• Last Update Posted: April 22, 2019
• Last Verified: April 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of California, Berkeley:

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

Additional relevant MeSH terms:

Sleep Wake Disorders; Parasomnias; Sleep Disorders, Circadian Rhythm; Disease; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Mental Disorders; Chronobiology Disorders; Dyssomnias; Occupational Diseases