InsomniaNCT05353296
Digital Cognitive-Behavioral Therapy for Insomnia in Spanish Speaking Latinas/os (Dormir Mejor Study)
A study testing Digital cognitive behavioral therapy for insomnia (CBT-I) program and Somryst (culturally adapted) in people with Insomnia, run by Columbia University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Insomnia
- What is being tested?
- Digital cognitive behavioral therapy for insomnia (CBT-I) program and Somryst (culturally adapted)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Apr 2022to 15 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia School of Social Work
New York, New York, 10027
About this study
Official title: Dormir Mejor Study: Randomized Controlled Trial of a Culturally Adapted Digital Program of Cognitive-Behavioral Therapy for Insomnia for Spanish Speaking Latina/o Primary Care Patients
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.
Read the detailed description
Chronic insomnia is associated with significant public health burden and most adults seek care for insomnia in the primary care setting. While Latina/os are at greater risk for insomnia than non-Hispanic Whites, access to the recommended first-line of treatment, cognitive behavioral therapy for insomnia, is limited especially for Spanish-speakers. Recent advances in health information technology such as self-guided digital health treatments represent an innovative and scalable means to address the supply and demand imbalance that perpetuate mental health care disparities, however its implementation in underserved communities remains elusive. The purpose of this study is to compare the effectiveness of a culturally adapted digital version of Cognitive Behavioral Therapy for Insomnia with minimally enhanced usual care on reduction of insomnia symptoms among Spanish-speaking Latina/os adults with chronic insomnia. The study will also examine barriers and facilitators to implementation, and examine cost-effectiveness of the intervention.
- Conditions
- Insomnia
- Being tested
- Digital cognitive behavioral therapy for insomnia (CBT-I) program, Minimally Enhanced Usual Care (mEUC), Somryst (culturally adapted)
- Keywords
- Insomnia, Behavioral Sleep Medicine, Digital Health, Hispanic, Latino, Sociocultural
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital cognitive behavioral therapy for insomnia (CBT-I) programBehavioural
A self-guided digital program of CBT-I (Somryst) that has been culturally adapted for Spanish-language speakers. Somryst is an interactive and tailored mobile-based program modeled on the primary tenets of face-to-face CBT-I. Patients will be asked to complete six cores (main intervention content) during the 9-week intervention period. The cores provide key content across six domains including behavioral (sleep restriction, stimulus control), cognitive (cognitive restricting), educational (sleep hygiene), overview, and consolidation/relapse prevention.
Minimally Enhanced Usual Care (mEUC)Behavioural
A minimally enhanced usual care, which will include usual care by patients' Primary Care Provider and a sleep hygiene brochure.
Somryst (culturally adapted)Device
FDA-authorized digital cognitive behavioral therapy for insomnia (CBT-I) trains your brain for better sleep.
| Study group | Role | What they receive |
|---|---|---|
| Culturally adapted digital cognitive behavioral therapy for insomnia (CBT-I) (Somryst) | Experimental | 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. Receives: Behavioral: Digital cognitive behavioral therapy for insomnia (CBT-I) program; Device: Somryst (culturally adapted) |
| Minimally Enhanced Usual Care (mEUC) | Active comparator | 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. Receives: Behavioral: Minimally Enhanced Usual Care (mEUC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mean Insomnia Severity Index Score (ISI)
ISI is a 7-item self-report scale measuring insomnia symptom severity in the last 2 weeks; summed score ranges 0-28, increasing score associated with increasing severity.
Measured: Baseline to post-intervention (9 weeks)
Change in Mean Insomnia Severity Index Score (ISI)
ISI is a 7-item self-report scale measuring insomnia symptom severity in the last 2 weeks; summed score ranges 0-28, increasing score associated with increasing severity.
Measured: Baseline to 6 months post intervention
Secondary outcomes (3)
Change in Mean Quality of Life Score (Short-Form 12 [SF-12], MCS, Mental Component Score)
Short Form (SF)-12 is a 12-item self-report inventory that generically measures quality of life; yields a measure of global health-related wellbeing as 8 domain-specific subscores on a 0-100 scale, increasing score reflects less dysfunction, impairment, or pain. Reporting change in mean mental health component score.
Measured: Baseline to post-intervention (9 weeks)
Change in Mean Daytime Sleepiness- Epworth Sleepiness Scale (ESS)
ESS is an 8-item brief self-report scale of daytime sleepiness; summed scores range 0-24, where increasing scores constitute greater sleepiness, and a score > 11 represents elevated daytime sleepiness.
Measured: Baseline to post-intervention (9 weeks)
Change in Mean Satisfaction With Care Patient Assessment of Chronic Illness Care (PACIC)
PACIC is a 20-item scale containing 5 subscales, adapted for this trial to measure respondents' receipt of services in regards to insomnia in the past 6 months, 5-point scale, range of 20-100 with increasing score reflecting greater satisfaction with care)
Measured: Baseline to post-intervention (9 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start7 Apr 2022
- Primary completion5 Jan 2024
- Study completion15 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a parallel-group, single-site, 2-arm Hybrid trial Type-1 effectiveness-implementation study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Carmela Alcantara, Columbia University
- Investigators
- Carmela Alcantara, PhD, Principal investigator, Columbia School of Social Work
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05353296
- Sponsor's protocol ID
- AAAS0318
- Other IDs
- R01HS024274
- Status last verified
- Jul 2025
- First submitted
- 15 Apr 2022
- Last updated
- 1 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Upon request, we plan to make available a de-identified database that includes ISI data, demographics and comorbidity characteristics of patients in our study.
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dormir Mejor Study: Randomized Controlled Trial of a Culturally Adapted Digital Program of Cognitive-Behavioral Therapy for Insomnia for Spanish Speaking Latina/o Primary Care Patients
- ClinicalTrials.gov ID
- NCT05353296
- Acronym / sponsor ID
- AAAS0318
- Conditions
- Insomnia
- Keywords
- Insomnia, Behavioral Sleep Medicine, Digital Health, Hispanic, Latino, Sociocultural
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 7 Apr 2022 (actual)
- Primary completion
- 5 Jan 2024 (actual)
- Study completion
- 15 Jul 2024 (actual)
- First posted
- 29 Apr 2022 (actual)
- Results
- Posted 14 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Chronic insomnia is associated with significant public health burden and most adults seek care for insomnia in the primary care setting. While Latina/os are at greater risk for insomnia than non-Hispanic Whites, access to the recommended first-line of treatment, cognitive behavioral therapy for insomnia, is limited especially for Spanish-speakers. Recent advances in health information technology such as self-guided digital health treatments represent an innovative and scalable means to address the supply and demand imbalance that perpetuate mental health care disparities, however its implementation in underserved communities remains elusive. The purpose of this study is to compare the effectiveness of a culturally adapted digital version of Cognitive Behavioral Therapy for Insomnia with minimally enhanced usual care on reduction of insomnia symptoms among Spanish-speaking Latina/os adults with chronic insomnia. The study will also examine barriers and facilitators to implementation, and examine cost-effectiveness of the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a parallel-group, single-site, 2-arm Hybrid trial Type-1 effectiveness-implementation study
| Arm | Type | Receives |
|---|---|---|
| Culturally adapted digital cognitive behavioral therapy for insomnia (CBT-I) (Somryst) | Experimental | Behavioral: Digital cognitive behavioral therapy for insomnia (CBT-I) program, Device: Somryst (culturally adapted)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. |
| Minimally Enhanced Usual Care (mEUC) | Active comparator | Behavioral: Minimally Enhanced Usual Care (mEUC)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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital cognitive behavioral therapy for insomnia (CBT-I) programA self-guided digital program of CBT-I (Somryst) that has been culturally adapted for Spanish-language speakers. Somryst is an interactive and tailored mobile-based program modeled on the primary tenets of face-to-face CBT-I. Patients will be asked to complete six cores (main intervention content) during the 9-week intervention period. The cores provide key content across six domains including behavioral (sleep restriction, stimulus control), cognitive (cognitive restricting), educational (sleep hygiene), overview, and consolidation/relapse prevention. | Behavioural | Culturally adapted digital cognitive behavioral therapy for insomnia (CBT-I) (Somryst) |
| Minimally Enhanced Usual Care (mEUC)A minimally enhanced usual care, which will include usual care by patients' Primary Care Provider and a sleep hygiene brochure. | Behavioural | Minimally Enhanced Usual Care (mEUC) |
| Somryst (culturally adapted)FDA-authorized digital cognitive behavioral therapy for insomnia (CBT-I) trains your brain for better sleep. | Device | Culturally adapted digital cognitive behavioral therapy for insomnia (CBT-I) (Somryst) |
Primary outcome
Change in Mean Insomnia Severity Index Score (ISI)
Time frame: Baseline to post-intervention (9 weeks)
ISI is a 7-item self-report scale measuring insomnia symptom severity in the last 2 weeks; summed score ranges 0-28, increasing score associated with increasing severity.
Change in Mean Insomnia Severity Index Score (ISI)
Time frame: Baseline to 6 months post intervention
ISI is a 7-item self-report scale measuring insomnia symptom severity in the last 2 weeks; summed score ranges 0-28, increasing score associated with increasing severity.
3 secondary outcomes
Change in Mean Quality of Life Score (Short-Form 12 [SF-12], MCS, Mental Component Score)
Time frame: Baseline to post-intervention (9 weeks)
Change in Mean Daytime Sleepiness- Epworth Sleepiness Scale (ESS)
Time frame: Baseline to post-intervention (9 weeks)
Change in Mean Satisfaction With Care Patient Assessment of Chronic Illness Care (PACIC)
Time frame: Baseline to post-intervention (9 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Upon request, we plan to make available a de-identified database that includes ISI data, demographics and comorbidity characteristics of patients in our study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carmela Alcantara, PhD principal investigator
Columbia School of Social Work
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital cognitive behavioral therapy for insomnia (CBT-I) program and Somryst (culturally adapted) in people with Insomnia, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Mean Insomnia Severity Index Score (ISI) (time frame: Baseline to post-intervention (9 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.