N/A
Completed N=7
Digital Cognitive-Behavioral Therapy for Insomnia in Spanish Speaking Latinas/os (Dormir Mejor Study)
Source: ClinicalTrials.gov NCT05353296 ↗Enrolled (actual)
7
Serious AEs
0.0%
Results posted
May 2025
Primary outcomePrimary: Change in Mean Insomnia Severity Index Score (ISI) — -6.7; -3.9 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Mean Insomnia Severity Index Score (ISI) |
-5.7; -1.6 | — |
| SECONDARY Change in Mean Quality of Life Score (Short-Form 12 [SF-12], MCS, Mental Component Score) |
10.8; 0.8 | — |
| SECONDARY Change in Mean Daytime Sleepiness- Epworth Sleepiness Scale (ESS) |
-2.3; 0.5 | — |
| SECONDARY Change in Mean Satisfaction With Care Patient Assessment of Chronic Illness Care (PACIC) |
17.4; -8.2 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05353296). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.