Perinatal Research on Improving Sleep and Mental Health

Depression Clinical Trial

— PRISM  

Official title:

Efficacy of Digital Cognitive Behavior Therapy for Insomnia for the Prevention of Perinatal Depression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05596318
• Other study ID #: 21-35440
• Status: Recruiting
• Phase: N/A
• Start date: November 2, 2022
• Est. completion date: April 2027

Study information

• Verified date: November 2023
• Source: University of California, San Francisco
• Contact: Jennifer N Felder, PhD
• Phone: 415-476-7014
• Email: jennifer.felder[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to compare two sleep programs in pregnant people with insomnia. The main questions it aims to answer are:

1. What is the efficacy of digital cognitive behavioral therapy for insomnia (CBT-I) versus digital sleep hygiene education (SHE) for preventing perinatal depression?

2. Is the effect of digital CBT-I on perinatal depression mediated through prenatal insomnia symptom improvement?

3. Is the effect of digital CBT-I on perinatal depression moderated by baseline depressive symptom severity?

Participants will receive one of two sleep programs - SHE or CBT-I. Both involve six weekly online sessions. Participants will complete surveys and interviews until 1 year postpartum.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 498
• Est. completion date: April 2027
• Est. primary completion date: April 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pregnant 14-28 weeks gestation

• 18 years or older

• Daily access to a web-enabled computer, smart phone, or tablet

• Current elevated insomnia symptom severity and insomnia disorder

• English speaking

Exclusion Criteria:

• Current major depression

• Taking or planning to take antidepressant medication (ADM)

• Other diagnosed or suspected sleep disorder

• Other psychiatric or medical issues (e.g., bipolar disorder, active suicidality, bed rest)

• Night shift worker

Related Conditions & MeSH terms

• Depression
• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Device:
• Digital CBT-I
The digital CBT-I program is called Sleepio (Big Health, Ltd). Digital CBT-I will be delivered by an animated therapist in six weekly sessions that are approximately 10-20 minutes each. Sessions can be accessed via website or app at a time that is convenient for the participant. Session content is based on standard, in-person CBT-I protocols, and includes sleep restriction, stimulus control, cognitive therapy, relaxation techniques, and sleep hygiene education. The program is interactive, automated, and tailored to participant progress. Additionally, participants will receive supplemental CBT-I content tailored for prenatal and postpartum insomnia.
• Digital SHE
The digital SHE program was created by Big Health, Ltd and has a total of six sessions. The content for SHE includes education about sleep stages, sleep architecture, sleep cycles; education about importance of sleep for performance, mood, and health; recommendations for developing healthy sleep habits; recommendations for lifestyle factors that impact sleep; recommendations for creating a sleep-friendly bedroom.

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of perinatal depression, as assessed by the Structured Clinical Interview for the DSM-5 (SCID)	This is a binary outcome that measures whether a participant experienced a depressive episode at any point since randomization.	Baseline to 12 months postpartum
Secondary	Change in depressive symptom severity from baseline to 12 months postpartum, as assessed by the Edinburgh Postnatal Depression Scale (EPDS)	The Edinburgh Postnatal Depression Scale (EPDS) score ranges from 0 to 30, with higher scores indicating greater depressive symptom severity.	Baseline to 12 months postpartum
Secondary	Change in depressive symptom severity from baseline to 12 months postpartum, as assessed by the Patient Health Questionnaire-9 (PHQ-9)	The Patient Health Questionnaire-9 (PHQ-9) score ranges from 0 to 27, with higher scores indicating greater depressive symptom severity.	Baseline to 12 months postpartum
Secondary	Change in suicidal ideation severity, as rated by the C-SSRS	The Columbia Suicide Severity Rating Scale suicidal ideation score ranges from 1-5, with greater scores indicating more severe ideation, based on the following categories: - Wish to be Dead; - Non-specific Active Suicidal Thoughts; - Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; - Active Suicidal Ideation with Some Intent to Act, without Specific Plan; - Active Suicidal Ideation with Specific Plan and Intent	Baseline to 12 months postpartum
Secondary	Change in anxiety symptom severity, as assessed by the GAD-7	The Generalized Anxiety Disorder-7 score ranges from 0 to 21, with higher scores indicating greater anxiety symptom severity.	Baseline to 12 months postpartum
Secondary	Change in prenatal insomnia symptom severity as a mediator of the effect of digital CBT-I on perinatal depression, as assessed by the ISI	The Insomnia Severity Index (ISI) score ranges from 0 to 28, with higher scores indicating greater insomnia severity.	Baseline to 10 weeks post-randomization (mediator)
Secondary	Baseline depressive symptom severity as a moderator, as assessed by the EPDS	The Edinburgh Postnatal Depression Scale (EPDS) score ranges from 0 to 30, with higher scores indicating greater depressive symptom severity.	Baseline
Secondary	Baseline depressive symptom severity as a moderator, as assessed by the PHQ-9	The Patient Health Questionnaire-9 (PHQ-9) score ranges from 0 to 27, with higher scores indicating greater depressive symptom severity.	Baseline