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Behavioural Intervention
Digital CBT-I and Digital SHE for Sleep Disorders, Insomnia, and Depression(PRISM Trial)
University of California, San Francisco, San Francisco, CA
Targeting 2 different conditionsDigital CBT-I +1 moreN/ARecruitingLed by Jennifer N Felder, PhDResearch Sponsored by University of California, San FranciscoEligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Current elevated insomnia symptom severity and insomnia disorder
Be older than 18 years old
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upbaseline to 12 months postpartum
Awards & highlights
No Placebo-Only Group
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.
Eligible Conditions
- Insomnia
- Depression
PRISM Trial Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You currently have severe insomnia symptoms and a diagnosed insomnia disorder.
PRISM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 12 months postpartum
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 12 months postpartum
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of perinatal depression, as assessed by the Structured Clinical Interview for the DSM-5 (SCID)
Secondary outcome measures
Depressive Symptoms
Baseline depressive symptom severity as a moderator, as assessed by the PHQ-9
Anxiety
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
PRISM Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Digital cognitive behavior therapy for insomnia (CBT-I)Experimental Treatment1 Intervention
Group II: Digital sleep hygiene education (SHE)Active Control1 Intervention
Find a Location
Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,449 Previous Clinical Trials
12,515,858 Total Patients Enrolled
8 Trials studying Insomnia
595 Patients Enrolled for Insomnia
Stanford UniversityOTHER
2,324 Previous Clinical Trials
17,287,435 Total Patients Enrolled
18 Trials studying Insomnia
3,444 Patients Enrolled for Insomnia
Jennifer N Felder, PhDPrincipal InvestigatorUniversity of California, San Francisco
2 Previous Clinical Trials
260 Total Patients Enrolled
1 Trials studying Insomnia
208 Patients Enrolled for Insomnia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Digital cognitive behavior therapy for insomnia (CBT-I)
- Group 2: Digital sleep hygiene education (SHE)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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