Primary Insomnia, Secondary Insomnia
Conditions
Brief 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.
Detailed description
Sleep disturbance in active duty military personnel is highly prevalent and contributes to reduced performance of military duties. Under extreme conditions, army personnel could endanger themselves and their comrades. Increasingly, non-pharmacological treatments for insomnia are showing promise as complementary and alternative medicine treatments. Many of these awareness training programs (ATPs) perform as well as, or even better than, medications. This study will determine whether Mind-Body Bridging (MBB), an ATP that teaches awareness/mindfulness and cognitive skills, is more effective than a common sleep medication, Zolpidem. The study will also determine whether MBB exhibits additional benefits in co-morbid mental health conditions, including, stress, PTSD, depression, etc, compared with that of Zolpidem. This will offer soldiers additional treatment options for insomnia in the hope that it will improve both sleep and other common comorbidities.
Interventions
DRUGZolpidem
Week 1: 10 mg Zolpidem daily for 1 week, Week 2: 10 mg Zolpidem daily for one week, taken as needed, Week 3: 5 mg Zolpidem daily for 1 week, taken as needed.
BEHAVIORALMind-Body Bridging
An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session
Sponsors
Evans Army Community Hospital
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
17 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Waking After Sleep Onset Using a Sleep Diary, From Baseline at 2 Month Follow-up | Baseline, 2 month follow up | Sleep Diary - 7 days of data collection; Waking After Sleep Onset (WASO, in min.): The duration of awakenings throughout the night, calculated after falling asleep to before the last awakening of waking up and not going back to sleep. Range 0 - 24 hr. A negative value reflects improvement in WASO at the 2-month follow-up. |
| Change in Total Sleep Time Using a Sleep Diary, From Baseline at 2 Month Follow-up | Baseline, 2 month follow up | Sleep Diary - 7 days of data collection; Total Sleep Time (TST, in min.): The amount of time asleep, calculated from the time of falling asleep to waking up. Range 0 - 24 hr. The greater the value the more total sleep was obtained. |
| Change in Sleep Onset Latency Using a Sleep Diary, From Baseline at 1-week Follow-up | Baseline, 1-week follow up | Sleep Diary - 7 days of data collection; Sleep Onset Latency (SOL, in min.): The time to fall asleep, calculated from the time of turning out the light to falling asleep. Range 0 - 24 hr. A negative value reflects an improvement in SOL at the 1-week follow-up. |
| Change in Sleep Onset Latency Using a Sleep Diary, From Baseline at 2 Month Follow-up | Baseline, 2 month follow up | Sleep Diary - 7 days of data collection; Sleep Onset Latency (SOL, in min.): The time to fall asleep, calculated from the time of turning out the light to falling asleep. Range 0 - 24 hr. A negative value reflects an improvement in SOL at the 2-month follow-up. |
| Change in Waking After Sleep Onset Using a Sleep Diary, From Baseline at 1-week Follow-up | Baseline, 1-week follow up | Sleep Diary - 7 days of data collection; Waking After Sleep Onset (WASO, in min.): The duration of awakenings throughout the night, calculated after falling asleep to before the last awakening of waking up and not going back to sleep. Range 0 - 24 hr. A negative value reflects improvement in WASO at the 1-week follow-up. |
| Change in Subjective Measures of Sleep Using Medical Outcomes Study -Sleep Scale, From Baseline at 1-week Follow-up | Baseline, 1-week follow up | Medical Outcomes Study - sleep scale. A 12-item validated questionnaire evaluating sleep outcomes over the past 7 days. The subscale Sleep Problems Index - II, is reported, range is 0-100. The greater the value the worse the sleep problems. In the present study, the greater the change from baseline the greater the improvement in sleep problems. |
| Change in Subjective Measures of Sleep Using Medical Outcomes Study -Sleep Scale, From Baseline at 2 Month Follow-up | Baseline, 2 month follow up | Medical Outcomes Study - sleep scale. A 12-item validated questionnaire evaluating sleep outcomes over the past 7 days. The subscale Sleep Problems Index - II, is reported, range is 0-100. The greater the value the worse the sleep problems. In the present study, the greater the change from baseline the greater the improvement in sleep problems. |
| Change in Insomnia Severity Index, From Baseline at 1-week Follow-up | Baseline, 1-week follow up | Insomnia Severity Index - A 7-item validated questionnaire evaluating severity of insomnia symptoms over the past 7 days. The total score is reported with a range of 0-28. The greater the value the greater the insomnia severity. In the present study, the greater the change from baseline the greater the improvement in insomnia severity. |
| Change in Insomnia Severity Index, From Baseline at 2 Month Follow-up | Baseline, 2 month follow up | Insomnia Severity Index - A 7-item validated questionnaire evaluating severity of insomnia symptoms over the past 7 days. The total score is reported with a range of 0-28. The greater the value the greater the insomnia severity. In the present study, the greater the change from baseline the greater the improvement in insomnia severity. |
| Change in Total Sleep Time Using a Sleep Diary, From Baseline at 1-week Follow-up | Baseline, 1-week follow up | Sleep Diary - 7 days of data collection. Total Sleep Time (TST, in min.): The amount of time asleep, calculated from the time of falling asleep to waking up. Range 0 - 24 hr. The greater the value the more total sleep was obtained. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Center for Epidemiologic Studies Depression Scale (CES-D) | Baseline, 2 month follow up | The CES-D is one of the most commonly validated screening tests for helping an individual to determine his or her depression quotient. The 20-item test measures depressive feelings and behaviors during the past week. Each item is summed to obtain a CES-D total score ranging from 0 to 60; higher scores indicate more severe depressive symptoms. A total score of 16 or higher was identified in early studies as indicative of individuals with depressive illness. |
| Connor-Davidson Resilience Scale (CD-RISC) | Baseline, 2 month follow up | One of the few well-validated measures of resilience is the Connor-Davidson Resilience Scale (CD-RISC), comprising 25 items. All items are summed to obtain a CD-RISC total score ranging from 0-100, with greater total scores indicating greater resilience. |
| Mindfulness Assessment (Five-facet Mindfulness Questionnaire; FFMQ) | Baseline, 2 month follow up | This is a validated questionnaire which tracks how facets of mindfulness may develop over time. It has 39 items and divides into 5 factors representing the various aspects of mindfulness. The range is 0-195. The greater the value the greater an individual's mindfulness level. |
| PTSD Check List (PCL) - Military (PCL-M) | Baseline, 2 month follow up | The PCL-M is a well-validated 17-item self-report measure to assess PTSD severity among military personnel; both male and female, to assess military-related PTSD. Reliability evidence is very good. Items are based on DSM criteria (DSM-IV criteria for this version) and are rated on a 5-point Likert-type scale that allows the derivation of a quantifiable total score.Range is 0-85, the greater the value the worse the PTSD reported symptoms. |
Countries
United States
Participant flow
Pre-assignment details
In Mind-Body Bridging, 41 participants consented, but one participant did not provide baseline assessment data; consequently, 40 Mind-Body Bridging participants' baseline data were included in the analyses.
Participants by arm
| Arm | Count |
|---|---|
| Zolpidem (Ambien) Treatment A three week treatment of Zolpidem
Zolpidem: Week 1: 10 mg Zolpidem daily for 1 week, Week 2: 10 mg Zolpidem daily for one week, taken as needed, Week 3: 5 mg Zolpidem daily for 1 week, taken as needed. | 31 |
| Mind-Body Bridging An awareness training program using mindfulness-based techniques.
Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session | 40 |
| Total | 71 |
Baseline characteristics
| Characteristic | Zolpidem (Ambien) Treatment | Mind-Body Bridging | Total |
|---|---|---|---|
| Age, Continuous | 29.9 years STANDARD_DEVIATION 8.2 | 30.1 years STANDARD_DEVIATION 6.9 | 30.0 years STANDARD_DEVIATION 7.4 |
| Sex/Gender, Customized Females | 25 participants | 35 participants | 60 participants |
| Sex/Gender, Customized Males | 5 participants | 5 participants | 10 participants |
| Sex/Gender, Customized Not Provided | 1 participants | 0 participants | 1 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 31 | 0 / 41 |
| serious Total, serious adverse events | 0 / 31 | 0 / 41 |
Outcome results
Primary
Change in Insomnia Severity Index, From Baseline at 1-week Follow-up
Insomnia Severity Index - A 7-item validated questionnaire evaluating severity of insomnia symptoms over the past 7 days. The total score is reported with a range of 0-28. The greater the value the greater the insomnia severity. In the present study, the greater the change from baseline the greater the improvement in insomnia severity.
Time frame: Baseline, 1-week follow up
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Zolpidem (Ambien) Treatment | Change in Insomnia Severity Index, From Baseline at 1-week Follow-up | 4.3 units on a scale |
| Mind-Body Bridging | Change in Insomnia Severity Index, From Baseline at 1-week Follow-up | 4.0 units on a scale |
p-value: 0.95ANCOVA
Primary
Change in Insomnia Severity Index, From Baseline at 2 Month Follow-up
Insomnia Severity Index - A 7-item validated questionnaire evaluating severity of insomnia symptoms over the past 7 days. The total score is reported with a range of 0-28. The greater the value the greater the insomnia severity. In the present study, the greater the change from baseline the greater the improvement in insomnia severity.
Time frame: Baseline, 2 month follow up
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Zolpidem (Ambien) Treatment | Change in Insomnia Severity Index, From Baseline at 2 Month Follow-up | 9.34 units on a scale |
| Mind-Body Bridging | Change in Insomnia Severity Index, From Baseline at 2 Month Follow-up | 6.38 units on a scale |
p-value: 0.08ANCOVA
Primary
Change in Sleep Onset Latency Using a Sleep Diary, From Baseline at 1-week Follow-up
Sleep Diary - 7 days of data collection; Sleep Onset Latency (SOL, in min.): The time to fall asleep, calculated from the time of turning out the light to falling asleep. Range 0 - 24 hr. A negative value reflects an improvement in SOL at the 1-week follow-up.
Time frame: Baseline, 1-week follow up
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Zolpidem (Ambien) Treatment | Change in Sleep Onset Latency Using a Sleep Diary, From Baseline at 1-week Follow-up | -5.9 minutes |
| Mind-Body Bridging | Change in Sleep Onset Latency Using a Sleep Diary, From Baseline at 1-week Follow-up | -11.1 minutes |
p-value: 0.52ANCOVA
Primary
Change in Sleep Onset Latency Using a Sleep Diary, From Baseline at 2 Month Follow-up
Sleep Diary - 7 days of data collection; Sleep Onset Latency (SOL, in min.): The time to fall asleep, calculated from the time of turning out the light to falling asleep. Range 0 - 24 hr. A negative value reflects an improvement in SOL at the 2-month follow-up.
Time frame: Baseline, 2 month follow up
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Zolpidem (Ambien) Treatment | Change in Sleep Onset Latency Using a Sleep Diary, From Baseline at 2 Month Follow-up | -7.5 minutes |
| Mind-Body Bridging | Change in Sleep Onset Latency Using a Sleep Diary, From Baseline at 2 Month Follow-up | -13.7 minutes |
p-value: 0.54ANCOVA
Primary
Change in Subjective Measures of Sleep Using Medical Outcomes Study -Sleep Scale, From Baseline at 1-week Follow-up
Medical Outcomes Study - sleep scale. A 12-item validated questionnaire evaluating sleep outcomes over the past 7 days. The subscale Sleep Problems Index - II, is reported, range is 0-100. The greater the value the worse the sleep problems. In the present study, the greater the change from baseline the greater the improvement in sleep problems.
Time frame: Baseline, 1-week follow up
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Zolpidem (Ambien) Treatment | Change in Subjective Measures of Sleep Using Medical Outcomes Study -Sleep Scale, From Baseline at 1-week Follow-up | 15.8 units on a scale |
| Mind-Body Bridging | Change in Subjective Measures of Sleep Using Medical Outcomes Study -Sleep Scale, From Baseline at 1-week Follow-up | 16.1 units on a scale |
p-value: 0.84ANCOVA
Primary
Change in Subjective Measures of Sleep Using Medical Outcomes Study -Sleep Scale, From Baseline at 2 Month Follow-up
Medical Outcomes Study - sleep scale. A 12-item validated questionnaire evaluating sleep outcomes over the past 7 days. The subscale Sleep Problems Index - II, is reported, range is 0-100. The greater the value the worse the sleep problems. In the present study, the greater the change from baseline the greater the improvement in sleep problems.
Time frame: Baseline, 2 month follow up
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Zolpidem (Ambien) Treatment | Change in Subjective Measures of Sleep Using Medical Outcomes Study -Sleep Scale, From Baseline at 2 Month Follow-up | 29.38 units on a scale |
| Mind-Body Bridging | Change in Subjective Measures of Sleep Using Medical Outcomes Study -Sleep Scale, From Baseline at 2 Month Follow-up | 21.04 units on a scale |
p-value: 0.11ANCOVA
Primary
Change in Total Sleep Time Using a Sleep Diary, From Baseline at 1-week Follow-up
Sleep Diary - 7 days of data collection. Total Sleep Time (TST, in min.): The amount of time asleep, calculated from the time of falling asleep to waking up. Range 0 - 24 hr. The greater the value the more total sleep was obtained.
Time frame: Baseline, 1-week follow up
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Zolpidem (Ambien) Treatment | Change in Total Sleep Time Using a Sleep Diary, From Baseline at 1-week Follow-up | 69.6 minutes |
| Mind-Body Bridging | Change in Total Sleep Time Using a Sleep Diary, From Baseline at 1-week Follow-up | 38.3 minutes |
p-value: 0.2ANCOVA
Primary
Change in Total Sleep Time Using a Sleep Diary, From Baseline at 2 Month Follow-up
Sleep Diary - 7 days of data collection; Total Sleep Time (TST, in min.): The amount of time asleep, calculated from the time of falling asleep to waking up. Range 0 - 24 hr. The greater the value the more total sleep was obtained.
Time frame: Baseline, 2 month follow up
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Zolpidem (Ambien) Treatment | Change in Total Sleep Time Using a Sleep Diary, From Baseline at 2 Month Follow-up | 74.14 minutes |
| Mind-Body Bridging | Change in Total Sleep Time Using a Sleep Diary, From Baseline at 2 Month Follow-up | 29.9 minutes |
p-value: 0.13ANCOVA
Primary
Change in Waking After Sleep Onset Using a Sleep Diary, From Baseline at 1-week Follow-up
Sleep Diary - 7 days of data collection; Waking After Sleep Onset (WASO, in min.): The duration of awakenings throughout the night, calculated after falling asleep to before the last awakening of waking up and not going back to sleep. Range 0 - 24 hr. A negative value reflects improvement in WASO at the 1-week follow-up.
Time frame: Baseline, 1-week follow up
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Zolpidem (Ambien) Treatment | Change in Waking After Sleep Onset Using a Sleep Diary, From Baseline at 1-week Follow-up | -4.3 minutes |
| Mind-Body Bridging | Change in Waking After Sleep Onset Using a Sleep Diary, From Baseline at 1-week Follow-up | -4.0 minutes |
p-value: 0.94ANCOVA
Primary
Change in Waking After Sleep Onset Using a Sleep Diary, From Baseline at 2 Month Follow-up
Sleep Diary - 7 days of data collection; Waking After Sleep Onset (WASO, in min.): The duration of awakenings throughout the night, calculated after falling asleep to before the last awakening of waking up and not going back to sleep. Range 0 - 24 hr. A negative value reflects improvement in WASO at the 2-month follow-up.
Time frame: Baseline, 2 month follow up
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Zolpidem (Ambien) Treatment | Change in Waking After Sleep Onset Using a Sleep Diary, From Baseline at 2 Month Follow-up | -4.8 minutes |
| Mind-Body Bridging | Change in Waking After Sleep Onset Using a Sleep Diary, From Baseline at 2 Month Follow-up | -4.5 minutes |
p-value: 0.95ANCOVA
Secondary
Center for Epidemiologic Studies Depression Scale (CES-D)
The CES-D is one of the most commonly validated screening tests for helping an individual to determine his or her depression quotient. The 20-item test measures depressive feelings and behaviors during the past week. Each item is summed to obtain a CES-D total score ranging from 0 to 60; higher scores indicate more severe depressive symptoms. A total score of 16 or higher was identified in early studies as indicative of individuals with depressive illness.
Time frame: Baseline, 2 month follow up
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Zolpidem (Ambien) Treatment | Center for Epidemiologic Studies Depression Scale (CES-D) | 19.5 units on a scale |
| Mind-Body Bridging | Center for Epidemiologic Studies Depression Scale (CES-D) | 24.5 units on a scale |
p-value: <0.01ANCOVA
Secondary
Connor-Davidson Resilience Scale (CD-RISC)
One of the few well-validated measures of resilience is the Connor-Davidson Resilience Scale (CD-RISC), comprising 25 items. All items are summed to obtain a CD-RISC total score ranging from 0-100, with greater total scores indicating greater resilience.
Time frame: Baseline, 2 month follow up
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Zolpidem (Ambien) Treatment | Connor-Davidson Resilience Scale (CD-RISC) | 72.9 units on a scale |
| Mind-Body Bridging | Connor-Davidson Resilience Scale (CD-RISC) | 62.3 units on a scale |
p-value: <0.01ANCOVA
Secondary
Mindfulness Assessment (Five-facet Mindfulness Questionnaire; FFMQ)
This is a validated questionnaire which tracks how facets of mindfulness may develop over time. It has 39 items and divides into 5 factors representing the various aspects of mindfulness. The range is 0-195. The greater the value the greater an individual's mindfulness level.
Time frame: Baseline, 2 month follow up
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Zolpidem (Ambien) Treatment | Mindfulness Assessment (Five-facet Mindfulness Questionnaire; FFMQ) | 126.9 units on a scale |
| Mind-Body Bridging | Mindfulness Assessment (Five-facet Mindfulness Questionnaire; FFMQ) | 120.1 units on a scale |
p-value: 0.13ANCOVA
Secondary
PTSD Check List (PCL) - Military (PCL-M)
The PCL-M is a well-validated 17-item self-report measure to assess PTSD severity among military personnel; both male and female, to assess military-related PTSD. Reliability evidence is very good. Items are based on DSM criteria (DSM-IV criteria for this version) and are rated on a 5-point Likert-type scale that allows the derivation of a quantifiable total score.Range is 0-85, the greater the value the worse the PTSD reported symptoms.
Time frame: Baseline, 2 month follow up
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Zolpidem (Ambien) Treatment | PTSD Check List (PCL) - Military (PCL-M) | 35.9 units on a scale |
| Mind-Body Bridging | PTSD Check List (PCL) - Military (PCL-M) | 38.0 units on a scale |
p-value: 0.49ANCOVA