Follow-up of a Study Examining Sleep Management in United States Veterans

Phase 1

Completed

• Conditions: Insomnia
• Interventions: Behavioral: Sleep Hygiene; Behavioral: Mind-Body Bridging Program

• Registration Number: NCT00935337
• Lead Sponsor: University of Utah

Brief Summary

The first part of the pilot study, as detailed in Unique Protocol ID No. 27522, is a randomized clinical trial that compares the effects of a mind-body bridging program with a sleep hygiene program to improve sleep quality in patients suffering from sleep disturbances. In Part II of the study, the investigators will perform a six month follow-up on the same subjects.

Detailed Description

In this follow-up, we ask subjects to answer the same questionnaires that they completed at the beginning of the study. In addition we will ask subjects to complete a survey reflecting their medical history over the past 6 months and a second survey establishing their behavioral patterns and whether they continued practicing techniques of the intervention they were assigned to.

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-06-18
• Study First Submitted QC: 2009-07-08
• Study First Posted: 2009-07-09
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-23
• Last Update Posted: 2011-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• Have participated in Part I of this study

Exclusion Criteria

• The patient presents with significant mental health issues, such as severe psychosis or major depression (as verified by the primary care provider) or the patient is under intensive mental health case management.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sleep Hygiene	Sleep Hygiene	Sleep Hygiene subjects will be accessed with questionnaires and medical history evaluations for the impact of SH over the past 6 months since undertaking the program.
Mind-Body Bridging Program	Mind-Body Bridging Program	Mind Body Bridging subjects will be accessed with questionnaires and medical history evaluations for the impact of MBBP over the past 6 months since undertaking the program.

Primary Outcome Measures

Name	Time	Method
Medical Outcomes Study-Sleep Scale	6 months following study part I
Medical Outcomes Study Short Form-36	6 months following study part I

Secondary Outcome Measures

Name	Time	Method
PTSD Check List-Military	6 months following study part I
Center for Epidemiologic Studies Depression Scale	6 months following study part I
Five-factor Mindfulness Questionnaire	6 months following study part I

Trial Locations

Locations (1)

SLC VA Medical Center; 🇺🇸 Salt Lake City, Utah, United States