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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00935337
Recruitment Status : Completed
First Posted : July 9, 2009
Last Update Posted : November 24, 2011
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Insomnia Behavioral: Mind-Body Bridging Program Behavioral: Sleep Hygiene Phase 1 Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Pilot Study of Two Contrasting Intervention Programs for Sleep Management - Part II
Study Start Date : April 2009
Primary Completion Date : September 2009
Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Healthy Sleep
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 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.
Behavioral: Mind-Body Bridging Program
Bridging aims to reduce the impact of negative thought patterns that contribute to stress in the body.
Other Name: MBBP
Active Comparator: 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.
Behavioral: Sleep Hygiene
treatment as usual
Other Name: SH


Outcome Measures

Primary Outcome Measures :
  1. Medical Outcomes Study-Sleep Scale [ Time Frame: 6 months following study part I ]
  2. Medical Outcomes Study Short Form-36 [ Time Frame: 6 months following study part I ]

Secondary Outcome Measures :
  1. Center for Epidemiologic Studies Depression Scale [ Time Frame: 6 months following study part I ]
  2. Five-factor Mindfulness Questionnaire [ Time Frame: 6 months following study part I ]
  3. PTSD Check List-Military [ Time Frame: 6 months following study part I ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00935337


Locations
United States, Utah
SLC VA Medical Center
Salt Lake City, Utah, United States, 84148
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Gavin West, M.D. Salt Lake City VA/University of Utah
More Information

Responsible Party: Gavin West, M.D., VA Medical Center/University of Utah
ClinicalTrials.gov Identifier: NCT00935337     History of Changes
Other Study ID Numbers: 34556
First Posted: July 9, 2009    Key Record Dates
Last Update Posted: November 24, 2011
Last Verified: November 2011

Keywords provided by University of Utah:
Sleep problems
Awareness training program
Mind body bridging