Digital Cognitive-Behavioral Therapy for Insomnia in Spanish Speaking Latinas/os (Dormir Mejor St… (NCT05353296) | Clinical Trial Compass
CompletedNot Applicable
Digital Cognitive-Behavioral Therapy for Insomnia in Spanish Speaking Latinas/os (Dormir Mejor Study)
United States7 participantsStarted 2022-04-07
Plain-language summary
The primary objective of the proposed study is to examine the effectiveness of a culturally adapted digital program of cognitive behavioral therapy for insomnia (CBT-I) compared to minimally enhanced usual care (mEUC) on primary outcomes: reduction in insomnia symptoms at 9 weeks and 6 months post-intervention, using a standard scale among Spanish-Speaking Latina/o adults with chronic insomnia.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Insomnia Severity Index Score for moderate insomnia symptoms (score\>10 on ISS)
* Spanish-speaking or bilingual (English and Spanish) and self-identify as Hispanic or Latina/o
* Report experience of sleep disturbances for at least 3x/week and for at least 3 months
Exclusion Criteria:
* Pregnancy
* Excessive sleepiness (score\>=16 on ESS)
* Caregivers of infants (\< 3 months) and/or of adults who require care at night
* Participants who are deemed unable to complete the study protocol due to dementia, severe cognitive impairment, severe medical or mental illness, or active substance use disorder
* Untreated moderate to severe obstructive sleep apnea or self-reported narcolepsy
* Unstable depression or insomnia medication regimen
* Patients who have full-time transportation/moving occupations
* Participation in another treatment/intervention study within the time period of initial baseline until the 6-month follow-up assessments
* Participation in regular night shift work, more than 1x/week, or non-standard sleep patterns
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Mean Insomnia Severity Index Score (ISI)
Timeframe: Baseline to post-intervention (9 weeks)
2
Change in Mean Insomnia Severity Index Score (ISI)