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Behavioral Intervention
Sleep and Circadian Rhythm + Memory Support for Sleep Disorders
N/A
Recruiting
Led By Allison Harvey, PhD
Research Sponsored by University of California, Berkeley
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 4 of treatment as well as post treatment, defined as two weeks after the final therapy session (i.e. 8-10 weeks after the initial intake interview) to 6-month follow-up to 12-month follow-up]
Awards & highlights
No Placebo-Only Group
Summary
This trial tests if a new intervention can help improve sleep, reduce disability, and improve memory in people 50+ with mental illness.
Who is the study for?
This trial is for individuals aged 50 and older who speak English, have mobility issues, low income, and show no signs of cognitive impairment. They must be experiencing sleep or circadian disturbances but not severe untreated sleep apnea or other conditions that severely affect sleep. Participants need to consent to communication between researchers and their medical providers.
What is being tested?
The study tests a new Memory Support Intervention (MSI) designed to improve treatment outcomes by enhancing patient memory. It focuses on people with mental illness suffering from sleep disorders and aims to see if MSI can better their sleep patterns, daily functioning, and memory retention.
What are the potential side effects?
Since this is a psychological intervention focusing on improving memory support through behavioral techniques rather than medication, specific side effects are not listed like those for drug trials. However, participants may experience changes in mood or stress levels due to the nature of the therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 4 of treatment as well as post treatment, defined as two weeks after the final therapy session (i.e. 8-10 weeks after the initial intake interview) to 6-month follow-up to 12-month follow-up]
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 4 of treatment as well as post treatment, defined as two weeks after the final therapy session (i.e. 8-10 weeks after the initial intake interview) to 6-month follow-up to 12-month follow-up]
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Patient-Reported Outcomes Measurement Information System - Sleep Disturbance
Satisfaction with Life Scale
Sheehan Disability Scale
Secondary study objectives
Adapted Utilization Scale
Cognitive Failures Questionnaire
Composite Sleep Health Score
+20 moreOther study objectives
Adapted Brief Disability Questionnaire
Adapted Credibility Expectancy Questionnaire
Adverse events checklist
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: TranS-C+MSIExperimental Treatment2 Interventions
Transdiagnostic Intervention for Sleep and Circadian Dysfunction will be combined with the Memory Support Intervention
Group II: TranS-C aloneActive Control1 Intervention
The Transdiagnostic Sleep and Circadian Intervention will be delivered alone
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transdiagnostic Intervention for Sleep and Circadian Dysfunction
2015
N/A
~130
Find a Location
Who is running the clinical trial?
University of California, BerkeleyLead Sponsor
187 Previous Clinical Trials
640,798 Total Patients Enrolled
Allison Harvey, PhDPrincipal InvestigatorUniversity of California, Berkeley
9 Previous Clinical Trials
1,753 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 50 years old or older.I have severe sleep apnea or moderate sleep apnea with extreme daytime tiredness.I have difficulty moving around.
Research Study Groups:
This trial has the following groups:- Group 1: TranS-C+MSI
- Group 2: TranS-C alone
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.