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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 Francisco

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 below
You currently have severe insomnia symptoms and a diagnosed insomnia disorder.

PRISM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 12 months postpartum
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 12 months postpartum for reporting.

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
+4 more

Awards & 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

Digital CBT-I (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05596318 — N/A
Insomnia Research Study Groups: Digital cognitive behavior therapy for insomnia (CBT-I), Digital sleep hygiene education (SHE)
Insomnia Clinical Trial 2023: Digital CBT-I Highlights & Side Effects. Trial Name: NCT05596318 — N/A
Digital CBT-I (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05596318 — N/A

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
~332 spots leftby Apr 2027