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OpenTrials
Completed

NCT Number: NCT03556878

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'.

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Key information

Conditions

Sleep Disorders, Circadian Rhythm Acceptability Adaptation Chronobiology Disorders Dyssomnias Feasibility Implementation Research Mental Disorders Nervous System Diseases Neurologic Manifestations Occupational Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorder Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UC Berkeley

Berkeley, California, 94702, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Fitted TranS-C

Primary outcomes

  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 outcomes

  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 outcomes

  1. Referral form

    Time frame: Baseline only

    Assesses participant suitability for the study

Sponsors and collaborators

Lead sponsor

University of California, Berkeley

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 14, 2018
Registry last updated
Apr 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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