Trial Outcomes & Findings for Digital Cognitive-Behavioral Therapy for Insomnia in Spanish Speaking Latinas/os (Dormir Mejor Study) (NCT NCT05353296)
NCT ID: NCT05353296
Last Updated: 2025-08-01
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
7 participants
Primary outcome timeframe
Baseline to post-intervention (9 weeks)
Results posted on
2025-08-01
Participant Flow
Participant milestones
| Measure |
Culturally Adapted Digital Cognitive Behavioral Therapy for Insomnia (CBT-I) (Somryst)
Somryst is an FDA-authorized digital cognitive behavioral therapy for insomnia (CBT-I) program that has been translated and culturally adapted for Spanish speakers. Participants 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)
Participants will continue their standard care with their primary care provider, which may include pharmacotherapy. In addition, participants will be provided a sleep hygiene brochure during group assignment.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
4
|
|
Overall Study
COMPLETED
|
3
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Digital Cognitive-Behavioral Therapy for Insomnia in Spanish Speaking Latinas/os (Dormir Mejor Study)
Baseline characteristics by cohort
| Measure |
Culturally Adapted Digital Cognitive Behavioral Therapy for Insomnia (CBT-I) (Somryst)
n=3 Participants
Somryst is an FDA-authorized digital cognitive behavioral therapy for insomnia (CBT-I) program that has been translated and culturally adapted for Spanish speakers. Participants 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)
n=4 Participants
Participants will continue their standard care with their primary care provider, which may include pharmacotherapy. In addition, participants will be provided a sleep hygiene brochure during group assignment.
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.0 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
52.4 years
STANDARD_DEVIATION 17.2 • n=7 Participants
|
49.2 years
STANDARD_DEVIATION 14.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Culturally Adapted Digital Cognitive Behavioral Therapy for Insomnia (CBT-I) (Somryst)
n=3 Participants
Somryst is an FDA-authorized digital cognitive behavioral therapy for insomnia (CBT-I) program that has been translated and culturally adapted for Spanish speakers. Participants 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)
n=4 Participants
Participants will continue their standard care with their primary care provider, which may include pharmacotherapy. In addition, participants will be provided a sleep hygiene brochure during group assignment.
|
|---|---|---|
|
Change in Mean Insomnia Severity Index Score (ISI)
|
-6.7 score on a scale
Interval -15.4 to 2.0
|
-3.9 score on a scale
Interval -12.5 to 4.7
|
PRIMARY outcome
Timeframe: Baseline to 6 months post interventionISI 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.
Outcome measures
| Measure |
Culturally Adapted Digital Cognitive Behavioral Therapy for Insomnia (CBT-I) (Somryst)
n=3 Participants
Somryst is an FDA-authorized digital cognitive behavioral therapy for insomnia (CBT-I) program that has been translated and culturally adapted for Spanish speakers. Participants 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)
n=4 Participants
Participants will continue their standard care with their primary care provider, which may include pharmacotherapy. In addition, participants will be provided a sleep hygiene brochure during group assignment.
|
|---|---|---|
|
Change in Mean Insomnia Severity Index Score (ISI)
|
-5.7 score on a scale
Interval -17.1 to 5.8
|
-1.6 score on a scale
Interval -13.0 to 9.9
|
SECONDARY outcome
Timeframe: Baseline to post-intervention (9 weeks)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.
Outcome measures
| Measure |
Culturally Adapted Digital Cognitive Behavioral Therapy for Insomnia (CBT-I) (Somryst)
n=3 Participants
Somryst is an FDA-authorized digital cognitive behavioral therapy for insomnia (CBT-I) program that has been translated and culturally adapted for Spanish speakers. Participants 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)
n=4 Participants
Participants will continue their standard care with their primary care provider, which may include pharmacotherapy. In addition, participants will be provided a sleep hygiene brochure during group assignment.
|
|---|---|---|
|
Change in Mean Quality of Life Score (Short-Form 12 [SF-12], MCS, Mental Component Score)
|
10.8 score on a scale
Interval 5.9 to 15.7
|
0.8 score on a scale
Interval -4.0 to 5.6
|
SECONDARY outcome
Timeframe: Baseline to post-intervention (9 weeks)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.
Outcome measures
| Measure |
Culturally Adapted Digital Cognitive Behavioral Therapy for Insomnia (CBT-I) (Somryst)
n=3 Participants
Somryst is an FDA-authorized digital cognitive behavioral therapy for insomnia (CBT-I) program that has been translated and culturally adapted for Spanish speakers. Participants 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)
n=4 Participants
Participants will continue their standard care with their primary care provider, which may include pharmacotherapy. In addition, participants will be provided a sleep hygiene brochure during group assignment.
|
|---|---|---|
|
Change in Mean Daytime Sleepiness- Epworth Sleepiness Scale (ESS)
|
-2.3 score on a scale
Interval -6.5 to 1.9
|
0.5 score on a scale
Interval -3.6 to 4.6
|
SECONDARY outcome
Timeframe: Baseline to post-intervention (9 weeks)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)
Outcome measures
| Measure |
Culturally Adapted Digital Cognitive Behavioral Therapy for Insomnia (CBT-I) (Somryst)
n=3 Participants
Somryst is an FDA-authorized digital cognitive behavioral therapy for insomnia (CBT-I) program that has been translated and culturally adapted for Spanish speakers. Participants 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)
n=4 Participants
Participants will continue their standard care with their primary care provider, which may include pharmacotherapy. In addition, participants will be provided a sleep hygiene brochure during group assignment.
|
|---|---|---|
|
Change in Mean Satisfaction With Care Patient Assessment of Chronic Illness Care (PACIC)
|
17.4 score on a scale
Interval -20.5 to 55.4
|
-8.2 score on a scale
Interval -41.9 to 25.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to post-intervention (9 weeks)PSQI is an 18-item questionnaire of sleep quality in the past month, summed scores range 0-21, where scores \>5 are associated with poor sleep quality and \<5 with good sleep quality)
Outcome measures
| Measure |
Culturally Adapted Digital Cognitive Behavioral Therapy for Insomnia (CBT-I) (Somryst)
n=3 Participants
Somryst is an FDA-authorized digital cognitive behavioral therapy for insomnia (CBT-I) program that has been translated and culturally adapted for Spanish speakers. Participants 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)
n=4 Participants
Participants will continue their standard care with their primary care provider, which may include pharmacotherapy. In addition, participants will be provided a sleep hygiene brochure during group assignment.
|
|---|---|---|
|
Change in Mean Sleep Quality Pittsburgh Sleep Quality Index (PSQI)
|
-1.0 score on a scale
Interval -2.6 to 0.6
|
-0.7 score on a scale
Interval -2.2 to 0.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to post-intervention (9 weeks)Population: This outcome is not able to be analyzed because data not collected.
Wake after sleep onset will be recorded in a 14-day sleep diary and refers to the self-reported total number of minutes participants spent awake after they fell asleep. Range: 24 hours Minimum value = 0 minutes (better) Maximum value = 1440 minutes (worse)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to post-intervention (9 weeks)Wake after sleep onset will be measured with 14-days of wrist-actigraphy and refers to the total number of minutes participants spent awake after they fell asleep. Range: 24 hours Minimum value = 0 minutes (better) Maximum value = 1440 minutes (worse)
Outcome measures
| Measure |
Culturally Adapted Digital Cognitive Behavioral Therapy for Insomnia (CBT-I) (Somryst)
n=3 Participants
Somryst is an FDA-authorized digital cognitive behavioral therapy for insomnia (CBT-I) program that has been translated and culturally adapted for Spanish speakers. Participants 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)
n=4 Participants
Participants will continue their standard care with their primary care provider, which may include pharmacotherapy. In addition, participants will be provided a sleep hygiene brochure during group assignment.
|
|---|---|---|
|
Change in Mean Actigraphy Assessed Wake After Sleep Onset
|
-2.5 minutes
Interval -38.5 to 33.6
|
-4.8 minutes
Interval -10.2 to 0.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to post-intervention (9 weeks)Sleep onset latency will be recorded in a 14-day sleep diary and refers to the number of minutes that it takes participants to fall asleep. Range: 24 hours Minimum value = 0 minutes (better) Maximum value = 1440 minutes (worse)
Outcome measures
| Measure |
Culturally Adapted Digital Cognitive Behavioral Therapy for Insomnia (CBT-I) (Somryst)
n=3 Participants
Somryst is an FDA-authorized digital cognitive behavioral therapy for insomnia (CBT-I) program that has been translated and culturally adapted for Spanish speakers. Participants 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)
n=4 Participants
Participants will continue their standard care with their primary care provider, which may include pharmacotherapy. In addition, participants will be provided a sleep hygiene brochure during group assignment.
|
|---|---|---|
|
Change in Mean Self-reported Sleep Onset Latency
|
-53.3 minutes
Interval -128.6 to 21.9
|
-16.9 minutes
Interval -84.7 to 51.0
|
Adverse Events
Culturally Adapted Digital Cognitive Behavioral Therapy for Insomnia (CBT-I) (Somryst)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Minimally Enhanced Usual Care (mEUC)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place