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

This study has been completed.

Sponsor:

Information provided by:

University of Utah

ClinicalTrials.gov Identifier:

NCT00935337

First received: June 18, 2009

Last updated: November 23, 2011

Last verified: November 2011

History of Changes

Purpose

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	Intervention	Phase
Insomnia	Behavioral: Mind-Body Bridging Program Behavioral: Sleep Hygiene	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	A Pilot Study of Two Contrasting Intervention Programs for Sleep Management - Part II

Resource links provided by NLM:

MedlinePlus related topics: Sleep Disorders

U.S. FDA Resources

Further study details as provided by University of Utah:

Primary Outcome Measures:

Medical Outcomes Study-Sleep Scale [ Time Frame: 6 months following study part I ] [ Designated as safety issue: No ]
Medical Outcomes Study Short Form-36 [ Time Frame: 6 months following study part I ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Center for Epidemiologic Studies Depression Scale [ Time Frame: 6 months following study part I ] [ Designated as safety issue: No ]
Five-factor Mindfulness Questionnaire [ Time Frame: 6 months following study part I ] [ Designated as safety issue: No ]
PTSD Check List-Military [ Time Frame: 6 months following study part I ] [ Designated as safety issue: No ]

Enrollment:	34
Study Start Date:	April 2009
Study Completion Date:	September 2009
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party:	Gavin West, M.D., VA Medical Center/University of Utah
ClinicalTrials.gov Identifier:	NCT00935337 History of Changes
Other Study ID Numbers:	34556
Study First Received:	June 18, 2009
Last Updated:	November 23, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Utah:

Sleep problems
Awareness training program
Mind body bridging

ClinicalTrials.gov processed this record on June 17, 2013

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