What is the mechanism of action of this treatment?

The most common treatments for insomnia include Cognitive Behavioral Therapy for Insomnia (CBT-I), which focuses on behavioral modification to improve sleep patterns and reduce insomnia symptoms. CBT-I works by addressing maladaptive thoughts and behaviors that contribute to insomnia, such as poor sleep hygiene, irregular sleep schedules, and anxiety about sleep. Techniques used in CBT-I include stimulus control, sleep restriction, cognitive restructuring, and relaxation training. These interventions help patients develop healthier sleep habits, reduce sleep-related anxiety, and improve overall sleep quality. This matters for insomnia patients as it provides a non-pharmacological, sustainable approach to managing and potentially resolving their sleep issues.

What side effects are associated with this type of intervention?

Digital Cognitive Behavioral Therapy for Insomnia (CBT-I) is a non-pharmacological treatment that generally has minimal side effects. Patients may experience temporary increases in anxiety or stress as they adjust to new sleep routines and the effort required to adhere to the therapy. This is in contrast to pharmacological treatments, which can have more significant side effects such as daytime drowsiness, dizziness, dependency, and withdrawal symptoms.

What prior FDA approvals exist?

The FDA has approved several pharmacologic treatments for insomnia, including benzodiazepine receptor agonists like zolpidem and eszopiclone, which work by enhancing the effect of the neurotransmitter GABA. However, for treatments similar to Digital Cognitive Behavioral Therapy for Insomnia (CBT-I), which focuses on behavioral modification, there are no specific FDA approvals as CBT-I is a non-pharmacologic intervention. CBT-I has been shown to be effective in improving sleep patterns and reducing insomnia symptoms through techniques such as sleep hygiene education, stimulus control, and cognitive restructuring. These behavioral strategies are recommended as first-line treatments for chronic insomnia by various clinical guidelines.

What other types of research exist?

Promising novel alternatives to Digital Cognitive Behavioral Therapy for Insomnia (CBT-I) for 2024 include: 1) Light therapy, which uses exposure to bright light to regulate circadian rhythms and improve sleep patterns. 2) Hypnosis, which has shown efficacy in reducing insomnia severity and improving sleep quality. 3) Smartphone applications for self-monitoring and behavioral modification, which have demonstrated benefits in managing sleep disorders. 4) Non-pharmacologic interventions like sleep hygiene education, which can be delivered digitally and focus on improving sleep habits and environment.

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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

Summary

This trial compares two online sleep programs for pregnant people with insomnia to see if they can prevent depression. One program focuses on changing thoughts and behaviors about sleep, while the other teaches good sleep habits. The program that changes thoughts and behaviors has been shown to be effective in various populations, including shift workers, menopausal women, and cancer survivors.

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.

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.

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.

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

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of perinatal depression, as assessed by the Structured Clinical Interview for the DSM-5 (SCID)

Secondary study objectives

Depressive Symptoms

Baseline depressive symptom severity as a moderator, as assessed by the PHQ-9

Anxiety

+4 more

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

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for insomnia include Cognitive Behavioral Therapy for Insomnia (CBT-I), which focuses on behavioral modification to improve sleep patterns and reduce insomnia symptoms. CBT-I works by addressing maladaptive thoughts and behaviors that contribute to insomnia, such as poor sleep hygiene, irregular sleep schedules, and anxiety about sleep. Techniques used in CBT-I include stimulus control, sleep restriction, cognitive restructuring, and relaxation training. These interventions help patients develop healthier sleep habits, reduce sleep-related anxiety, and improve overall sleep quality. This matters for insomnia patients as it provides a non-pharmacological, sustainable approach to managing and potentially resolving their sleep issues.

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor

2,551 Previous Clinical Trials

15,257,388 Total Patients Enrolled

8 Trials studying Insomnia

595 Patients Enrolled for Insomnia

Stanford UniversityOTHER

2,448 Previous Clinical Trials

17,491,896 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

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

~287 spots leftby Apr 2027

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