Pilot Study on Sleep Management for US Veterans - Full Text View

Sponsored by:	University of Utah
Information provided by:	University of Utah
ClinicalTrials.gov Identifier:	NCT00933959

Purpose

The aim of the proposed pilot study is to scientifically evaluate the use of Mind-Body Bridging Program (MBBP) as an effective intervention for improving health outcomes in veterans exhibiting sleep disturbance in the Primary Care Clinic at the Veterans Administration Salt Lake City Health Care System (VASLCHCS).

Condition	Intervention	Phase
Insomnia	Behavioral: Mind-Body Bridging Program Behavioral: Sleep Hygiene	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Pilot Study of Two Contrasting Intervention Programs for Sleep Management

Further study details as provided by University of Utah:

Primary Outcome Measures:

Medical Outcomes Study-Sleep Scale [ Time Frame: Pre-treatment, Week 1, Post treatment ] [ Designated as safety issue: No ]
Medical Outcomes Study Short Form-36 for Veterans [ Time Frame: Pre-treatment, Post treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Center for Epidemiologic Studies Depression Scale [ Time Frame: Pre-treatment, Post treatment ] [ Designated as safety issue: No ]
Five-factor Mindfulness Questionnaire [ Time Frame: Pre-treatment, Post treatment ] [ Designated as safety issue: No ]
PTSD Check List-Military [ Time Frame: Pre-treatment, Post treatment ] [ Designated as safety issue: No ]

Enrollment:	60
Study Start Date:	March 2008
Study Completion Date:	March 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Mind-Body Bridging Program: Experimental Subjects will undergo two approximately 1.5 hr training sessions using MBBP spaced one week apart at the VASLCHCS. Each training session will comprise a number of objectives: Session 1: The patient will discover the underlying cause of the insomnia. The patient will learn how to use easy to apply tools to quieten the mind to sleep soundly. Session 2: The patient will learn how to reduce daytime stress. The patient will experience a greater sense of self. To be maximally effective, the participant should master these objectives and practice MBBP on a daily basis. Bridging and all the other MBBP techniques can be implemented at any time throughout the day and right up to the onset of sleep.	Behavioral: Mind-Body Bridging Program Bridging aims to reduce the impact of negative thought patterns that contribute to stress in the body.
Sleep Hygiene: Active Comparator Participants in the sleep hygiene arm will receive a 1 hr class directing them to the importance of following a list of up to 15 points (tips) for getting to sleep. These points include: limiting alcohol and caffeine intake before bed, using the bed only for sleeping, and having regular bedtimes. Once the instructor has gone over this list and has described in detail each of the 15 points, the class will have an opportunity to ask questions. The participant will be encouraged to learn and practice the objectives of the sleep hygiene class on a daily basis.	Behavioral: Sleep Hygiene Treatment as usual

Arms

Assigned Interventions

Mind-Body Bridging Program: Experimental

Subjects will undergo two approximately 1.5 hr training sessions using MBBP spaced one week apart at the

VASLCHCS. Each training session will comprise a number of objectives:

Session 1:

The patient will discover the underlying cause of the insomnia.
The patient will learn how to use easy to apply tools to quieten the mind to sleep soundly.

Session 2:

The patient will learn how to reduce daytime stress.
The patient will experience a greater sense of self.

To be maximally effective, the participant should master these objectives and practice MBBP on a daily basis. Bridging and all the other MBBP techniques can be implemented at any time throughout the day and right up to the onset of sleep.

Behavioral: Mind-Body Bridging Program

Bridging aims to reduce the impact of negative thought patterns that contribute to stress in the body.

Sleep Hygiene: Active Comparator

Participants in the sleep hygiene arm will receive a 1 hr class directing them to the importance of following a list of up to 15 points (tips) for getting to sleep. These points include: limiting alcohol and caffeine intake before bed, using the bed only for sleeping, and having regular bedtimes. Once the instructor has gone over this list and has described in detail each of the 15 points, the class will have an opportunity to ask questions. The participant will be encouraged to learn and practice the objectives of the sleep hygiene class on a daily basis.

Behavioral: Sleep Hygiene

Treatment as usual

Detailed Description:

Participants will be randomly assigned to either MBBP or a treatment as usual sleep hygiene (SH) group. The interventions will last two weeks in which participants will attend 2 classes 1-1.5 hr each over two consecutive weeks. Assessment of the effects of the treatments will be based on self-report outcome measures; participants will complete five questionnaires approximately one week prior to the start of the interventions (pre-treatment) and one week after the second session (post-treatment). The sleep quality assessment questionnaire will be additionally completed after the first session (Week 1).

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Selection of subjects will be based on the patients exhibiting sleep disturbance as assessed by a standardized sleep questionnaire. Because we are also interested in the effects of MBBP on co-morbid illnesses besides insomnia, we will include subjects that are being treated for depression, pain, and general medical conditions, except as defined as exclusion criteria. Subjects using anti-depressants, sleep and pain medications, and other medications for any condition that is not under exclusion criteria will be admitted to the study. Thus our inclusion criteria will be broader than those based on DSM-IV for primary insomnia.
On the day of the study session, patients must arrive before the session for intervention assignment and to turn in their packets, and thereafter on the same day they must be able to attend a mind-body bridging program or sleep hygiene class (see Study Procedure). In addition, they must also be able to attend the second session the following week.

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: NCT00933959

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:	SLC VA Medical Center/University of Utah ( Gavin West, M.D. )
Study ID Numbers:	27522
Study First Received:	June 18, 2009
Last Updated:	July 6, 2009
ClinicalTrials.gov Identifier:	NCT00933959 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Utah:

Sleep problems
Awareness training program
Mind body bridging

Study placed in the following topic categories:

Dyssomnias
Sleep Disorders

ClinicalTrials.gov processed this record on September 10, 2009