Two Contrasting Interventions for Sleep Management

NCT ID: NCT01804036

Last Updated: 2017-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2016-11-30

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.

Conditions

Primary Insomnia; Secondary Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Zolpidem (Ambien) Treatment

A three week treatment of Zolpidem

Group Type: ACTIVE_COMPARATOR

Zolpidem

Intervention Type: DRUG

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 Bridging

An awareness training program using mindfulness-based techniques.

Group Type: EXPERIMENTAL

Mind-Body Bridging

Intervention Type: BEHAVIORAL

An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session

Interventions

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.

Intervention Type: DRUG

Mind-Body Bridging

An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session

Intervention Type: BEHAVIORAL

Other Intervention Names

Ambien; Awareness Training

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

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Evans Army Community Hospital

OTHER

Sponsor Role: collaborator

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Yoshio Nakamura

Research Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yoshio Nakamura, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

Evans Army Community Hospital

Colorado Springs, Colorado, United States

University of Utah

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

IRBNet-193532-1

Identifier Type: -

Identifier Source: org_study_id