Your session is about to expire
← Back to Search
Behavioral Intervention
Cognitive Behavioral Therapy for Insomnia to Treat Depression
N/A
Recruiting
Led By Andrea Goldstein-Piekarski, PhD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 days
Treatment 8 weeks
Follow Up 3 days
Awards & highlights
No Placebo-Only Group
Summary
This trial will test whether an intervention that improves sleep patterns can also reduce depressive symptoms by improving emotion regulation brain function.
Who is the study for?
This trial is for adults aged 25-60 near Stanford University who speak English and have had sleep disturbances for over 3 months, along with depression but not at immediate suicide risk. Exclusions include recent CBT-I therapy, trauma exposure, untreated severe sleep apnea, certain medical conditions or medications affecting sleep/mood, substance abuse, bipolar disorder or psychosis.
What is being tested?
The study tests if Cognitive Behavioral Therapy for Insomnia (CBT-I) can reduce depressive symptoms by improving brain function related to emotion regulation in those with poor sleep and depression. It involves weekly sessions over 8 weeks and uses fMRI scans to measure changes in the brain.
What are the potential side effects?
Since CBT-I is a non-medical treatment involving behavioral strategies like mindfulness and education about sleep hygiene, it typically does not have physical side effects. However, some may experience temporary increased stress or anxiety due to changes in their sleeping patterns.
Timeline
Screening ~ 3 days2 visits
Treatment ~ 8 weeks0 visits
Follow Up ~ 3 days2 visits
Screening ~ 3 days
Treatment ~ 8 weeks
Follow Up ~3 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Beck Depression Inventory
Brain
Change in Emotion Regulation Network brain connectivity as assessed by functional magnetic resonance imaging
+1 moreSecondary study objectives
Change in Actigraph Number of Arousals as a Measure of Sleep Continuity
Change in Actigraph Sleep Efficiency (SE) as a Measure of Sleep Continuity
Change in Actigraph Sleep Onset Latency (SOL) as a Measure of Sleep Continuity
+14 moreSide effects data
From 2015 Phase 2 & 3 trial • 150 Patients • NCT007676241%
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: CBT-IExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive Behavioral Therapy for Insomnia
2013
Completed Phase 3
~1930
Find a Location
Who is running the clinical trial?
National Institute of Mental Health (NIMH)NIH
2,918 Previous Clinical Trials
2,739,895 Total Patients Enrolled
701 Trials studying Depression
261,081 Patients Enrolled for Depression
Stanford UniversityLead Sponsor
2,472 Previous Clinical Trials
17,501,748 Total Patients Enrolled
108 Trials studying Depression
93,796 Patients Enrolled for Depression
Andrea Goldstein-Piekarski, PhDPrincipal Investigator - Stanford University
Stanford University
2 Previous Clinical Trials
199 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have experienced a traumatic event within the past 3 months or are currently experiencing trauma.You are currently pregnant or breastfeeding.You have trouble sleeping and have been experiencing it for at least three months.You have received cognitive behavioral therapy for insomnia within the past year.You have a mild brain injury.You feel sad and have symptoms of depression, but you are not currently at risk of hurting yourself. This will be measured by a test called CSSRS.You are taking medication that greatly affects your sleep, alertness or mood.You have a history of drug or alcohol abuse.You currently have a serious or unstable health condition.Your eyesight, hearing, or hand movements are severely impaired and may affect your ability to follow the study instructions.You drink more than 14 alcoholic drinks in a week or more than 4 drinks at one time.You have or have had bipolar disorder or psychosis at any point in your life.You are currently undergoing or planning to undergo cognitive behavior therapy or other psychotherapies for a different condition.You have recently had thoughts of harming yourself and have been assessed to be at high risk for suicide.You have other sleep or body clock disorders.
Research Study Groups:
This trial has the following groups:- Group 1: CBT-I
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: You will receive the treatment for 8 Weeks
- Follow Ups: You may be asked to continue sharing information regarding the trial for 3 Months after you stop receiving the treatment.
Depression Patient Testimony for trial: Trial Name: NCT04424407 — N/A
Other Trials to Consider
Popular Categories
Learn More About These Treatments
Share this study with friends
Copy Link
Messenger