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Behavioral Intervention

Immediate Treatment for Insomnia

N/A
Waitlist Available
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjective complaint of depressive symptoms as defined by scores of ≥ 14 on the BDI
Insomnia complaint ≥ 3 months in duration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at baseline (week 1), end of treatment (week 13), and 6-month follow-up (week 36)
Awards & highlights

Study Summary

This trial is the second part of a study looking at how a sleep intervention called Cognitive Behavioral Therapy for Insomnia (CBT-I) affects the brain's emotion regulation network.

Who is the study for?
This trial is for individuals who are experiencing sleep disorders, depression, and insomnia. Participants should be interested in a non-medication approach to improve their condition.Check my eligibility
What is being tested?
The study is testing Cognitive Behavioral Therapy for Insomnia (CBT-I) to see if it can help manage symptoms of depression and anxiety by targeting the brain's emotion regulation network.See study design
What are the potential side effects?
CBT-I generally has minimal side effects compared to medication; however, some may experience temporary increases in anxiety or frustration as they adjust their sleeping habits.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I feel very sad or depressed, as shown by my depression score.
Select...
I have had trouble sleeping for at least 3 months.
Select...
I often struggle to sleep and it affects my day.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed at baseline (week 1), end of treatment (week 13), and 6-month follow-up (week 36)
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at baseline (week 1), end of treatment (week 13), and 6-month follow-up (week 36) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Beck Depression Inventory
Change in Emotion Regulation Network brain activation as assessed by functional magnetic resonance imaging
Change in Emotion Regulation Network brain connectivity as assessed by functional magnetic resonance imaging
+1 more
Secondary outcome measures
Change in 36-Item Short Form Survey (SF-36) Score
Change in Actigraph Number of Arousals as a Measure of Sleep Continuity
Change in Actigraph Sleep Efficiency (SE) as a Measure of Sleep Continuity
+13 more

Side effects data

From 2015 Phase 2 & 3 trial • 150 Patients • NCT00767624
1%
Hematoma R side abdomen
1%
Severe vaginal bleeding and pain
1%
Chest pain in a patient with CAD
1%
Asthma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Antidepressant + Desensitization
Antidepressant + Cognitive Behavioral

Trial Design

2Treatment groups
Experimental Treatment
Group I: Monitored ControlExperimental Treatment1 Intervention
Participants randomized to the Monitored Control group will receive the same CBT-I treatment approximately 7 months after randomization.
Group II: Immediate TreatmentExperimental Treatment1 Intervention
Participants randomized to the Immediate Treatment group will receive CBT-I treatment immediately after randomization.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive Behavioral Therapy for Insomnia
2013
Completed Phase 3
~1800

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,395 Previous Clinical Trials
17,341,305 Total Patients Enrolled
19 Trials studying Insomnia
3,942 Patients Enrolled for Insomnia
National Institute of Mental Health (NIMH)NIH
2,786 Previous Clinical Trials
2,689,542 Total Patients Enrolled
9 Trials studying Insomnia
912 Patients Enrolled for Insomnia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

May I inquire about the criteria for potential participation in this medical study?

"Patients aged between 25 and 60 years with a diagnosis of depression are eligible to participate in this clinical study, which aims to recruit approximately 150 individuals."

Answered by AI

What are the main goals that this clinical trial aims to achieve?

"This study aims to evaluate alterations in the brain's Emotion Regulation Network activation using functional magnetic resonance imaging. The assessment will occur at baseline (week 1), end of treatment (week 13), and during a follow-up at 6 months (week 36). Secondary measures include variations in sleep architecture, specifically Total Sleep Time as recorded by polysomnography, Number of Arousals indicating sleep continuity interruptions observed via actigraphy data, and Total Sleep Time reflecting uninterrupted rest periods also assessed through actigraphy."

Answered by AI

Is the current investigation open for participant enrollment?

"As per clinicaltrials.gov, the current status of this trial is not accepting new participants. The trial was listed on 7/1/2024 and last updated on 4/15/2024. Despite its closure for recruitment, there are currently 1667 active trials seeking candidates for participation."

Answered by AI

Can individuals older than 45 years participate in this research study?

"To be eligible for this trial, participants must fall between the ages of 25 and 60 years."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Novel Use of a Sleep Intervention to Target the Emotion Regulation Brain Network to Treat Depression and Anxiety (R33 Phase)
Andrea Goldstein-Piekarski 2024. "A Novel Use of a Sleep Intervention to Target the Emotion Regulation Brain Network to Treat Depression and Anxiety (R33 Phase)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06373718.
~100 spots leftby Jun 2027
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