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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Pilot Study of Two Contrasting Intervention Programs for Sleep Management - Part II

Conditions
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Insomnia

Intervention / Treatment
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* Behavioral: Mind-Body Bridging Program
* Behavioral: Sleep Hygiene


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mind-Body Bridging Program<br>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. | Behavioral: Mind-Body Bridging Program<br>* Bridging aims to reduce the impact of negative thought patterns that contribute to stress in the body.<br>* Other names: MBBP;|
| Active Comparator: Sleep Hygiene<br>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. | Behavioral: Sleep Hygiene<br>* treatment as usual<br>* Other names: SH;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Center for Epidemiologic Studies Depression Scale |  | 6 months following study part I | 
| Five-factor Mindfulness Questionnaire |  | 6 months following study part I | 
| PTSD Check List-Military |  | 6 months following study part I | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep problems, Awareness training program, Mind body bridging