N/A
N=21
Reduce Emotional Symptoms of Insomnia With SleepTreatment
Insomnia · Rumination
Bottom Line
View on ClinicalTrials.gov: NCT03724305 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Insomnia Severity Index — 16.42; 8.37; 11.72 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mindfulness-Based Therapy for Insomnia (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Henry Ford Health System
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Insomnia Severity Index |
16.42; 8.37; 11.72 | — |
| PRIMARY Five Facet Mindfulness Questionnaire-15 (FFMQ-15) |
52.95; 57.42; 55.50 | — |
Summary
The purpose of this research is to test whether Mindfulness-Based Therapy for Insomnia (MBTI) significantly reduces symptoms of insomnia and cognitive arousal in patients with treatment-resistant insomnia.
Eligibility Criteria
Inclusion Criteria
- Determination of insomnia (ISI>10)
- Inadequate response to prior insomnia psychotherapy (e.g., CBTI) and/or pharmacotherapy per patient report.
Exclusion Criteria
- Age < 18
- Current use of antidepressants for depression
- Bipolar or Seizure disorders
- Known sleep disorders other than insomnia (e.g. obstructive sleep apnea, narcolepsy, restless leg syndrome).
Data sourced from ClinicalTrials.gov (NCT03724305). 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.