Phase 3
N=72
Two Contrasting Interventions for Sleep Management
Primary Insomnia · Secondary Insomnia
Bottom Line
View on ClinicalTrials.gov: NCT01804036 ↗Enrolled (actual)
72
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: Change in Subjective Measures of Sleep Using Medical Outcomes Study -Sleep Scale, From Baseline at 1-week Follow-up — 15.8; 16.1 units on a scale — p=0.84
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Zolpidem (Drug); Mind-Body Bridging (Behavioral)
- Age
- Pediatric, Adult · 17+ yrs
- Sex
- All
- Sponsor
- University of Utah
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Subjective Measures of Sleep Using Medical Outcomes Study -Sleep Scale, From Baseline at 1-week Follow-up |
15.8; 16.1 | 0.84 |
| PRIMARY Change in Subjective Measures of Sleep Using Medical Outcomes Study -Sleep Scale, From Baseline at 2 Month Follow-up |
29.38; 21.04 | 0.11 |
| PRIMARY Change in Insomnia Severity Index, From Baseline at 1-week Follow-up |
4.3; 4.0 | 0.95 |
| PRIMARY Change in Insomnia Severity Index, From Baseline at 2 Month Follow-up |
9.34; 6.38 | 0.08 |
| PRIMARY Change in Total Sleep Time Using a Sleep Diary, From Baseline at 1-week Follow-up |
69.6; 38.3 | 0.20 |
| PRIMARY Change in Total Sleep Time Using a Sleep Diary, From Baseline at 2 Month Follow-up |
74.14; 29.9 | 0.13 |
| PRIMARY Change in Sleep Onset Latency Using a Sleep Diary, From Baseline at 1-week Follow-up |
-5.9; -11.1 | 0.52 |
| PRIMARY Change in Sleep Onset Latency Using a Sleep Diary, From Baseline at 2 Month Follow-up |
-7.5; -13.7 | 0.54 |
| PRIMARY Change in Waking After Sleep Onset Using a Sleep Diary, From Baseline at 1-week Follow-up |
-4.3; -4.0 | 0.94 |
| PRIMARY Change in Waking After Sleep Onset Using a Sleep Diary, From Baseline at 2 Month Follow-up |
-4.8; -4.5 | 0.95 |
| SECONDARY PTSD Check List (PCL) - Military (PCL-M) |
35.9; 38.0 | 0.49 |
| SECONDARY Center for Epidemiologic Studies Depression Scale (CES-D) |
19.5; 24.5 | <0.01 sig |
| SECONDARY Connor-Davidson Resilience Scale (CD-RISC) |
72.9; 62.3 | <0.01 sig |
| SECONDARY Mindfulness Assessment (Five-facet Mindfulness Questionnaire; FFMQ) |
126.9; 120.1 | 0.13 |
Summary
This study will determine whether Mind-Body Bridging (MBB), a mindfulness training program is more effective than a common sleep medication, Zolpidem, in treating insomnia. It will also investigate whether MBB is additionally beneficial for co-morbid conditions such as stress, PTSD, depression, etc, compared with that of Zolpidem.
Eligibility Criteria
Inclusion Criteria
- primary insomnia
- secondary insomnia
- requiring sleep medication (Zolpidem) for a three-week trial.
- active duty military service member stationed at Fort Carson.
Exclusion Criteria
- secondary insomnia to a likely medical condition, such as sleep apnea, chronic obstructive pulmonary disease, restless leg syndrome, and other sleep disorders, which are not appropriately treatable with sleep medication.
- treated for sleep problems using sleep medications which include Lunesta, Ambien, Ambien Controlled Release (CR), Seroquel, Trazodone or Remeron
- major psychopathology (i.e., schizophrenia)
- severe depression within the past 90 days
- suicidal ideation within the past 90 days
- psychiatrically hospitalized within the past 90 days
- uncontrolled hypertension or diabetes
- pregnancy
- previous use of Zolpidem proved to be ineffective or to cause other unwanted side effects
- actively abusing controlled substances
- enrolled in another study
Data sourced from ClinicalTrials.gov (NCT01804036). 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.