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Behavioural Intervention

digital CBT-I for Insomnia (CrEDIT Trial)

N/A
Waitlist Available
Research Sponsored by Big Health Inc.
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 -1 compared to weeks 10, 16, and 24 post-randomization
Awards & highlights

CrEDIT Trial Summary

This trial will compare two methods of reducing insomnia - digital CBT-I and sleep hygiene education - to see which is more effective.

Eligible Conditions
  • Insomnia

CrEDIT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week -1 compared to weeks 10, 16, and 24 post-randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and week -1 compared to weeks 10, 16, and 24 post-randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Change in sleep diary parameters: percent sleep efficiency (SE), total sleep time (TST), total time in bed (TTIB), and total wake time (TWT)
Change in sleep onset latency (SOL)
Change in the Generalized Anxiety Disorder Questionnaire (GAD-7)
+6 more

CrEDIT Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Digital CBT-IExperimental Treatment1 Intervention
Digitally-delivered CBT for insomnia accessed via web and/or mobile app
Group II: Sleep hygiene educationActive Control1 Intervention
This group will receive access to sleep hygiene education delivered via digital written materials
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
digital CBT-I
2022
N/A
~340

Find a Location

Who is running the clinical trial?

Big Health Inc.Lead Sponsor
11 Previous Clinical Trials
138,995 Total Patients Enrolled
4 Trials studying Insomnia
136,867 Patients Enrolled for Insomnia
University of California, San FranciscoOTHER
2,503 Previous Clinical Trials
15,236,319 Total Patients Enrolled
9 Trials studying Insomnia
1,093 Patients Enrolled for Insomnia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still places available for people in this clinical trial?

"That is correct. According to the information available on clinicaltrials.gov, this study was posted on November 8th, 2020 and is still actively looking for patients. The trial needs a total of 332 individuals from 1 site."

Answered by AI

How many people are allowed to be in this trial at any given time?

"That's correct, the listing on clinicaltrials.gov affirms that this study is currently looking for patients to enroll. The trial was initially posted on November 8th, 2020 and has had no updates since then. There is a need for 332 people total at a single location."

Answered by AI

Who else is applying?

What state do they live in?
New Hampshire
Other
Georgia
California
What site did they apply to?
University of California, San Francisco
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
2
3+

Why did patients apply to this trial?

Ive tried se er. I tried various treamenys to no avail. Frustration and big impacts (neg) on my job performance.
PatientReceived 2+ prior treatments
I've battled with insomnia since I was 27 &it dictates my. I have tried many different sleep medications with no success. I am currently taking Trazodone along with either Lunesta or Amtriptyline in order to sleep. These medications do not result in good sleep and leave me groggy in the morning. As a result of this, I am taking Modafinil during the day in order to stay awake during the day. I am very interested in Cognitive Behavior Therapy in order to stop taking all of these medications.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

How long does a session last? How many visits to your facility are required and for how long each time?
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Digital CBT-I for Insomnia Disorder
2022. "Digital CBT-I for Insomnia Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05541055.
~139 spots leftby Apr 2025
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