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Digital Cognitive Behavioral Therapy for Insomnia
N/A
Recruiting
Led By Carmela Alcantara, PhD
Research Sponsored by Columbia University
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 6 months post intervention
Awards & highlights
Study Summary
This trial will compare a digital CBT-I program to usual care in reducing insomnia symptoms in Spanish-Speaking Latina/o adults with chronic insomnia.
Who is the study for?
This trial is for Spanish-speaking or bilingual Hispanic/Latina/o adults with chronic insomnia, experiencing sleep disturbances at least three times a week for over three months. Pregnant individuals, caregivers of infants or those needing night care, and people with certain medical conditions like severe sleep apnea or narcolepsy are excluded.Check my eligibility
What is being tested?
The study tests the effectiveness of a culturally adapted digital cognitive behavioral therapy program (CBT-I) called Somryst against minimally enhanced usual care in reducing insomnia symptoms among participants at 9 weeks and 6 months post-intervention.See study design
What are the potential side effects?
As this is a non-pharmacological intervention focusing on behavior modification through digital means, significant side effects are not anticipated. However, some users may experience discomfort due to changes in their sleep habits.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 6 months post intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 6 months post intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Sleeplessness
Secondary outcome measures
Change in mean Satisfaction with Care Patient Assessment of Chronic Illness Care (PACIC)
Change in mean daytime sleepiness- Epworth Sleepiness Scale (ESS)
Change in mean quality of life score (Short-Form 12 [SF-12])
Other outcome measures
Change in mean Sleep quality Pittsburgh Sleep Quality Index (PSQI)
Change in mean actigraphy assessed wake after sleep onset
Change in mean self-reported sleep onset latency
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Culturally adapted digital cognitive behavioral therapy for insomnia (CBT-I) (Somryst)Experimental Treatment2 Interventions
Somryst is an FDA-authorized digital cognitive behavioral therapy for insomnia (CBT-I) program that has been translated and culturally adapted for Spanish speakers. Group will have access to this culturally-adapted Somryst, along with the usual care provided by their primary care provider, and will be provided a sleep hygiene brochure during group assignment.
Group II: Minimally Enhanced Usual Care (mEUC)Active Control1 Intervention
Usual care by their primary care provider and a sleep hygiene brochure. Group will continue their typical standard care with their primary care provider, which may include pharmacotherapy. In addition, we will provide a sleep hygiene brochure during group assignment.
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Who is running the clinical trial?
Agency for Healthcare Research and Quality (AHRQ)FED
399 Previous Clinical Trials
6,822,148 Total Patients Enrolled
Columbia UniversityLead Sponsor
1,432 Previous Clinical Trials
2,460,773 Total Patients Enrolled
2 Trials studying Insomnia
34 Patients Enrolled for Insomnia
Carmela Alcantara, PhDPrincipal InvestigatorColumbia School of Social Work
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have severe cognitive issues, serious illness, or active substance use that would stop me from completing the study.I have moderate to severe sleep apnea or narcolepsy that hasn't been treated.I have had trouble sleeping at least 3 times a week for the last 3 months.My medication for depression or insomnia is not stable.
Research Study Groups:
This trial has the following groups:- Group 1: Culturally adapted digital cognitive behavioral therapy for insomnia (CBT-I) (Somryst)
- Group 2: Minimally Enhanced Usual Care (mEUC)
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: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the uppermost threshold of participants taking part in this clinical investigation?
"Affirmative. Information on clinicaltrials.gov conveys that this study is actively seeking volunteers, with the trial posted April 7th 2022 and revised September 16th of the same year. The total amount of participants needed by this medical centre stands at 200 individuals."
Answered by AI
Could I be eligible to join this medical experiment?
"The requirements for enrolment in this trial involve a diagnosis of insomnia and being between 18 to 75 years old. Approximately 200 people are expected to be accepted into the study."
Answered by AI
Is the sign-up process currently open for this clinical trial?
"Affirmative. Details found on clinicaltrials.gov attest that this medical trial, which was originally posted on April 7th 2022, is actively recruiting patients. Approximately 200 participants need to be sought from 1 locations."
Answered by AI
Is enrollment open to those over 40 years old for this clinical trial?
"The prerequisites for joining this experiment specify that participants must be between 18 and 75 years old. In addition, 24 studies are available to minors aged below 18 while 179 investigations exist specifically for seniors over the age of 65."
Answered by AI
Who else is applying?
What state do they live in?
New York
How old are they?
18 - 65
What site did they apply to?
Columbia School of Social Work
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
3+
Why did patients apply to this trial?
I have tried supplements, prescriptions, black out curtains, eye masks, ear plugs.
PatientReceived 2+ prior treatments
I saw the trials on facebook an# decded to try this . I never troed anything for my insomnia.
PatientReceived 1 prior treatment
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