Overview

This trial is active, not recruiting.

Conditions primary insomnia, secondary insomnia
Treatments zolpidem, mind-body bridging
Phase phase 2/phase 3
Sponsor University of Utah
Collaborator Evans Army Community Hospital
Start date March 2013
End date September 2014
Trial size 60 participants
Trial identifier NCT01804036, IRBNet-193532-1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
A three week treatment of Zolpidem
zolpidem 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.
(Experimental)
An awareness training program using mindfulness-based techniques.
mind-body bridging Awareness Training
An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session

Primary Outcomes

Measure
Change in subjective measures of sleep using Medical Outcomes Study -Sleep Scale, from baseline to 3 months
time frame: Baseline, Weekly, Two weeks post MBB treatment/one week post Zolpidem treatment, 2 month follow up
Change in Insomnia Severity Index, from baseline to 3 months
time frame: Baseline, Weekly, Two weeks post MBB treatment/one week post Zolpidem treatment, 2 month follow up
Change in subjective measures of sleep using a sleep diary, from baseline to 3 months
time frame: Baseline, during treatment (Week 2), Two weeks post MBB treatment/one week post Zolpidem treatment, 2 month follow up

Secondary Outcomes

Measure
PTSD Check List (PCL) - Military (PCL-M)
time frame: Baseline, Two weeks post MBB treatment/one week post Zolpidem treatment, 2 month follow up
Center for Epidemiologic Studies Depression Scale (CES-D)
time frame: Baseline, Two weeks post MBB treatment/one week post Zolpidem treatment, 2 month follow up
Mindfulness Assessment (Five-facet Mindfulness Questionnaire; FFMQ)
time frame: Baseline, Two weeks post MBB treatment/one week post Zolpidem treatment, 2 month follow up
Connor-Davidson Resilience Scale (CD-RISC)
time frame: Baseline, Two weeks post MBB treatment/one week post Zolpidem treatment, 2 month follow up

Eligibility Criteria

Male or female participants from 17 years up to 40 years old.

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

Additional Information

Official title A Pilot Study of Two Contrasting Intervention Programs for Sleep Management
Principal investigator Yoshio Nakamura, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by University of Utah.