Primary InsomniaPhase 2/3NCT01804036
Two Contrasting Interventions for Sleep Management
A Phase 2/3 study testing Zolpidem and Mind-Body Bridging in people with Primary Insomnia and Secondary Insomnia, run by University of Utah at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 17 to 40 years
- Conditions the study is for
- Primary Insomnia, Secondary Insomnia
- What is being tested?
- Zolpidem and Mind-Body Bridging
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2013to Nov 2016
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- primary insomnia
- secondary insomnia
- requiring sleep medication (Zolpidem) for a three-week trial.
- active duty military service member stationed at Fort Carson.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Evans Army Community Hospital
Colorado Springs, Colorado, 80913
University of Utah
Salt Lake City, Utah, 84108
About this study
Official title: A Pilot Study of Two Contrasting Intervention Programs for Sleep Management
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.
Read the 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.
- Conditions
- Primary Insomnia, Secondary Insomnia
- Being tested
- Zolpidem, Mind-Body Bridging
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZolpidemDrug
Also called Ambien
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.
Mind-Body BridgingBehavioural
Also called Awareness Training
An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session
| Study group | Role | What they receive |
|---|---|---|
| Zolpidem (Ambien) Treatment | Active comparator | A three week treatment of Zolpidem Receives: Drug: Zolpidem |
| Mind-Body Bridging | Experimental | An awareness training program using mindfulness-based techniques. Receives: Behavioral: Mind-Body Bridging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1-week follow up
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.
Measured: Baseline, 2 month follow up
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.
Measured: Baseline, 1-week follow up
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.
Measured: Baseline, 2 month follow up
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.
Measured: Baseline, 1-week follow up
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.
Measured: Baseline, 2 month follow up
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.
Measured: Baseline, 1-week follow up
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.
Measured: Baseline, 2 month follow up
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.
Measured: Baseline, 1-week follow up
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.
Measured: Baseline, 2 month follow up
Secondary outcomes (4)
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.
Measured: Baseline, 2 month follow up
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.
Measured: Baseline, 2 month follow up
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.
Measured: Baseline, 2 month follow up
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.
Measured: Baseline, 2 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Primary InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Evans Army Community Hospital
- Responsible party
- Principal investigator, Yoshio Nakamura, University of Utah
- Investigators
- Yoshio Nakamura, PhD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01804036
- Sponsor's protocol ID
- IRBNet-193532-1
- Status last verified
- Feb 2017
- First submitted
- 28 Feb 2013
- Last updated
- 30 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Two Contrasting Intervention Programs for Sleep Management
- ClinicalTrials.gov ID
- NCT01804036
- Acronym / sponsor ID
- IRBNet-193532-1
- Conditions
- Primary Insomnia, Secondary Insomnia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Evans Army Community Hospital
- Study start
- Mar 2013
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 5 Mar 2013 (estimated)
- Results
- Posted 30 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zolpidem (Ambien) Treatment | Active comparator | Drug: ZolpidemA three week treatment of Zolpidem |
| Mind-Body Bridging | Experimental | Behavioral: Mind-Body BridgingAn awareness training program using mindfulness-based techniques. |
Who may qualify
- Ages
- 17 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- primary insomnia
- secondary insomnia
- requiring sleep medication (Zolpidem) for a three-week trial.
- active duty military service member stationed at Fort Carson.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZolpidemAlso: AmbienWeek 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. | Drug | Zolpidem (Ambien) Treatment |
| Mind-Body BridgingAlso: Awareness TrainingAn awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session | Behavioural | Mind-Body Bridging |
Primary outcome
Change in Subjective Measures of Sleep Using Medical Outcomes Study -Sleep Scale, From Baseline at 1-week Follow-up
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Change in Total Sleep Time Using a Sleep Diary, From Baseline at 2 Month Follow-up
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 Waking After Sleep Onset Using a Sleep Diary, From Baseline at 2 Month Follow-up
Time frame: 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.
4 secondary outcomes
PTSD Check List (PCL) - Military (PCL-M)
Time frame: Baseline, 2 month follow up
Center for Epidemiologic Studies Depression Scale (CES-D)
Time frame: Baseline, 2 month follow up
Connor-Davidson Resilience Scale (CD-RISC)
Time frame: Baseline, 2 month follow up
Mindfulness Assessment (Five-facet Mindfulness Questionnaire; FFMQ)
Time frame: Baseline, 2 month follow up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Primary Insomnia
Recruiting
Effect of Lifestyle Intervention on Menopausal Symptoms, Sleep Quality, and Anxiety in Peri- and Postmenopausal Women
Perimenopause, Postmenopause
Recruiting
Effectiveness of Transcranial Direct Current in Patients With Persistent COVID-19 With Headaches and Chronic Pain.
COVID-19, Long COVID
Active, not recruiting
Active Coping: Interdisciplinary Program for Chronic Pain, Physiotherapy Unit (Spain)
Chronic Back Pain, Chronic Pain
Not yet recruitingObservational study
Tension-type Headache and Its Association
Tension-Type Headache, Sleep Disturbance
RecruitingObservational study
Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
Coronavirus Infection (COVID-19), Pulmonary Arterial Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yoshio Nakamura, PhD principal investigator
University of Utah
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Zolpidem and Mind-Body Bridging in people with Primary Insomnia and Secondary Insomnia, run by University of Utah at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Subjective Measures of Sleep Using Medical Outcomes Study -Sleep Scale, From Baseline at 1-week Follow-up (time frame: Baseline, 1-week follow up). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2017.