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Digital CBT-I and Digital SHE for Sleep Disorders, Insomnia, and Depression(PRISM Trial)
PRISM Trial Summary
This trial will compare two sleep programs to see which is more effective for preventing perinatal depression in pregnant people with insomnia. Participants will complete online sessions and surveys until 1 year postpartum.
PRISM Trial Eligibility Criteria
Inclusion CriteriaYou will be eligible if you check “Yes” for the criteria below
PRISM Trial Timeline
Study ObjectivesOutcome measures can provide a clearer picture of what you can expect from a treatment.
Awards & Highlights
PRISM Trial Design
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Who is running the clinical trial?
- You have been diagnosed with or are suspected to have a sleep disorder.You have other mental or physical health problems that could affect your ability to take part in the study.You work overnight.You currently have severe insomnia symptoms and a diagnosed insomnia disorder.You are currently experiencing severe depression.You are currently taking or planning to take antidepressant medication.
- Group 1: Digital cognitive behavior therapy for insomnia (CBT-I)
- Group 2: Digital sleep hygiene education (SHE)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
What is the total number of participants being recruited for this clinical trial?
"Affirmative - according to clinicaltrials.gov, the trial is actively recruiting patients. The study was listed on November 2nd 2022 and has been updated since then; as of now, 498 participants are sought from a single site for this medical research effort."
Is the patient recruitment phase of this clinical trial ongoing?
"As of this date, the trial is still in its recruitment phase. According to records on clinicaltrials.gov, it was initially posted on November 2nd 2022 and has since had one update registered on that same day."
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