Clinical trial NCT01804036: Two Contrasting Interventions for Sleep Management
Official title: A Pilot Study of Two Contrasting Intervention Programs for Sleep Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Primary Insomnia
Secondary Insomnia
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Evans Army Community Hospital
First posted: 2013-03-05
Enrollment: 72
Sex: ALL
Minimum age (years): 17
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Subjective Measures of Sleep Using Medical Outcomes Study -Sleep Scale, From Baseline at 1-week Follow-up
timeFrame: Baseline, 1-week follow up
measure: Change in Subjective Measures of Sleep Using Medical Outcomes Study -Sleep Scale, From Baseline at 2 Month Follow-up
timeFrame: Baseline, 2 month follow up
measure: Change in Insomnia Severity Index, From Baseline at 1-week Follow-up
timeFrame: Baseline, 1-week follow up
measure: Change in Insomnia Severity Index, From Baseline at 2 Month Follow-up
timeFrame: Baseline, 2 month follow up
measure: Change in Total Sleep Time Using a Sleep Diary, From Baseline at 1-week Follow-up
timeFrame: Baseline, 1-week follow up
measure: Change in Total Sleep Time Using a Sleep Diary, From Baseline at 2 Month Follow-up
timeFrame: Baseline, 2 month follow up
measure: Change in Sleep Onset Latency Using a Sleep Diary, From Baseline at 1-week Follow-up
timeFrame: Baseline, 1-week follow up
measure: Change in Sleep Onset Latency Using a Sleep Diary, From Baseline at 2 Month Follow-up
timeFrame: Baseline, 2 month follow up
measure: Change in Waking After Sleep Onset Using a Sleep Diary, From Baseline at 1-week Follow-up
timeFrame: Baseline, 1-week follow up
measure: Change in Waking After Sleep Onset Using a Sleep Diary, From Baseline at 2 Month Follow-up
timeFrame: Baseline, 2 month follow up
Secondary outcomes:
measure: PTSD Check List (PCL) - Military (PCL-M)
timeFrame: Baseline, 2 month follow up
measure: Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: Baseline, 2 month follow up
measure: Connor-Davidson Resilience Scale (CD-RISC)
timeFrame: Baseline, 2 month follow up
measure: Mindfulness Assessment (Five-facet Mindfulness Questionnaire; FFMQ)
timeFrame: Baseline, 2 month follow up
Other outcomes:
Locations:
city: Colorado Springs
country: United States
facility: Evans Army Community Hospital
state: Colorado
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Yoshio Nakamura, PhD
role: PRINCIPAL_INVESTIGATOR
References: