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Behavioural Intervention
Digital Sleep Programs for Preventing Perinatal Depression (PRISM Trial)
N/A
Recruiting
Led By Jennifer N Felder, PhD
Research Sponsored by University of California, San Francisco
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 baseline to 12 months postpartum
Awards & highlights
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.
Who is the study for?
This trial is for pregnant individuals between 14-28 weeks gestation, aged 18 or older, who have insomnia and access to the internet. They must speak English but can't join if they work night shifts, have other sleep disorders or severe psychiatric conditions like bipolar disorder or active suicidality, are currently majorly depressed, or take antidepressants.Check my eligibility
What is being tested?
The study compares two digital programs for improving sleep in pregnant people with insomnia: cognitive behavioral therapy (CBT-I) and sleep hygiene education (SHE). Each participant will follow one of these six-week online courses to see which is better at preventing depression during and after pregnancy.See study design
What are the potential side effects?
Since both interventions are non-pharmacological and involve only educational content delivered digitally, there are no direct physical side effects expected from participating in this trial.
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 morePRISM 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
2,506 Previous Clinical Trials
15,238,057 Total Patients Enrolled
8 Trials studying Insomnia
595 Patients Enrolled for Insomnia
Stanford UniversityOTHER
2,395 Previous Clinical Trials
17,340,857 Total Patients Enrolled
19 Trials studying Insomnia
3,594 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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 14 and 28 weeks pregnant.I am currently on or planning to start antidepressant medication.I do not have severe psychiatric issues or conditions requiring bed rest.I am currently diagnosed with major depression.I have been diagnosed with or suspect I have another sleep disorder.I am currently experiencing severe insomnia.I am 18 years old or older.
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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