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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
Subjective complaint of sleep disturbance for ≥ 3 months (ISI>15)
Subjective complaint of depression (BDI≥14) and not at imminent risk for suicide, as measured by CSSRS assessment
Timeline
Screening 3 days
Treatment 8 weeks
Follow Up 3 days
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have trouble sleeping and have been experiencing it for at least three months.
Select...
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.

Timeline

Screening ~ 3 days
Treatment ~ 8 weeks
Follow Up ~3 days
This trial's timeline: 3 days for screening, 8 weeks for treatment, and 3 days 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
Brain
Change in Emotion Regulation Network brain connectivity as assessed by functional magnetic resonance imaging
+1 more
Secondary outcome measures
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 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

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
~1800

Find a Location

Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH
2,780 Previous Clinical Trials
2,674,824 Total Patients Enrolled
665 Trials studying Depression
251,348 Patients Enrolled for Depression
Stanford UniversityLead Sponsor
2,381 Previous Clinical Trials
17,333,598 Total Patients Enrolled
105 Trials studying Depression
93,664 Patients Enrolled for Depression
Andrea Goldstein-Piekarski, PhDPrincipal Investigator - Stanford University
Stanford University
2 Previous Clinical Trials
199 Total Patients Enrolled

Media Library

Cognitive Behavioral Therapy for Insomnia (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04424407 — N/A
Depression Research Study Groups: CBT-I
Depression Clinical Trial 2023: Cognitive Behavioral Therapy for Insomnia Highlights & Side Effects. Trial Name: NCT04424407 — N/A
Cognitive Behavioral Therapy for Insomnia (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04424407 — N/A
Depression Patient Testimony for trial: Trial Name: NCT04424407 — N/A

Frequently Asked Questions

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

Does this study have any age restrictions?

"According to the study's inclusion criteria, patients must be aged 25 to 60 to enroll. For context, there are 227 similar studies for people under 18 and 1154 for senior citizens aged 65 and up."

Answered by AI

What are the measurable goals of this clinical trial?

"The aim of this study, which will be observed over a period of 11 weeks, is to see the Change in Emotion Regulation Network brain connectivity as assessed by functional magnetic resonance imaging. Additionally, the study will measure the Change in PSG Total Sleep Time (TST) as a Measure of Sleep Architecture, Change in Sleep Physiology measured by PSG, and Change in PSG Sleep Onset Latency (SOL) as a Measure of Sleep Architecture."

Answered by AI

Could I enroll as a subject in this research?

"This trial is looking for 70 individuals, aged 25 to 60, who have been experiencing depression for at least 3 months. To be eligible, participants must also drink less than 3 cups of caffeine a day and have no suicidal thoughts or tendencies."

Answered by AI

Who else is applying?

What state do they live in?
Texas
California
What site did they apply to?
Stanford University
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
2
0
3+
1

Why did patients apply to this trial?

Insomnia is affecting every aspect of my life. I've been battling with insomnia since I was 27 years old &.
PatientReceived no prior treatments
I sleep poorly naybec3 hours. A night and am worried I dint get REM sleep.
PatientReceived no prior treatments
I’ve tried 6 different drugs and TMS treatments. I’m desperate to find some help.
PatientReceived 1 prior treatment
I have insomnia and currently take medication to sleep but would like a better way.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

How often do I have to travel? Do you have any help with transportation to/from Stanford?
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Stanford University: < 48 hours
Average response time
  • < 2 Days
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
Andrea Goldstein-Piekarski 2021. "A Novel Use of a Sleep Intervention to Target the Emotion Regulation Brain Network to Treat Depression and Anxiety". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04424407.
~18 spots leftby Apr 2025
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