Two Contrasting Interventions for Sleep Management

Primary Insomnia Clinical Trial

Official title:

A Pilot Study of Two Contrasting Intervention Programs for Sleep Management

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01804036
• Other study ID #: IRBNet-193532-1
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: February 28, 2013
• Last updated: April 27, 2015
• Start date: March 2013
• Est. completion date: July 2015

Study information

• Verified date: April 2015
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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 of Zolpidem.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: July 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Primary Insomnia
• Secondary Insomnia

Intervention

Drug:
• 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.

Behavioral:
• Mind-Body Bridging
An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session

Locations

Country	Name	City	State
United States	Evans Army Community Hospital	Colorado Springs	Colorado
United States	University of Utah	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	Evans Army Community Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in subjective measures of sleep using Medical Outcomes Study -Sleep Scale, from baseline to 3 months	Medical Outcomes Study - sleep scale. A 12-item validated questionnaire evaluating sleep outcomes over the past 7 days.	Baseline, Weekly, Two weeks post MBB treatment/one week post Zolpidem treatment, 2 month follow up	No
Primary	Change in Insomnia Severity Index, from baseline to 3 months	Insomnia Severity Index	Baseline, Weekly, Two weeks post MBB treatment/one week post Zolpidem treatment, 2 month follow up	No
Primary	Change in subjective measures of sleep using a sleep diary, from baseline to 3 months	Sleep Diary - 7 days of data collection	Baseline, during treatment (Week 2), Two weeks post MBB treatment/one week post Zolpidem treatment, 2 month follow up	No
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 the latest version) and are rated on a 5-point Likert-type scale that allows the derivation of a quantifiable total score.	Baseline, Two weeks post MBB treatment/one week post Zolpidem treatment, 2 month follow up	No
Secondary	Center for Epidemiologic Studies Depression Scale (CES-D)	The CES-D is one of the most common 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.	Baseline, Two weeks post MBB treatment/one week post Zolpidem treatment, 2 month follow up	No
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.	Baseline, Two weeks post MBB treatment/one week post Zolpidem treatment, 2 month follow up	No
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.	Baseline, Two weeks post MBB treatment/one week post Zolpidem treatment, 2 month follow up	No