Pilot Study on Sleep Management for US 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. Identifier: NCT00933959
Recruitment Status : Completed
First Posted : July 8, 2009
Last Update Posted : July 8, 2009
Information provided by:
University of Utah

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

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).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 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
Study Start Date : March 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Experimental: Mind-Body Bridging Program

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:

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

Session 2:

  1. The patient will learn how to reduce daytime stress.
  2. 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.
Other Name: MBBP
Active Comparator: Sleep Hygiene
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
Other Name: SH

Primary Outcome Measures :
  1. Medical Outcomes Study-Sleep Scale [ Time Frame: Pre-treatment, Week 1, Post treatment ]
  2. Medical Outcomes Study Short Form-36 for Veterans [ Time Frame: Pre-treatment, Post treatment ]

Secondary Outcome Measures :
  1. Center for Epidemiologic Studies Depression Scale [ Time Frame: Pre-treatment, Post treatment ]
  2. Five-factor Mindfulness Questionnaire [ Time Frame: Pre-treatment, Post treatment ]
  3. PTSD Check List-Military [ Time Frame: Pre-treatment, Post treatment ]

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

Inclusion Criteria:

  1. 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.
  2. 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:

  1. 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.

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 identifier (NCT number): NCT00933959

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

Responsible Party: Gavin West, M.D., SLC VA Medical Center/University of Utah Identifier: NCT00933959     History of Changes
Other Study ID Numbers: 27522
First Posted: July 8, 2009    Key Record Dates
Last Update Posted: July 8, 2009
Last Verified: July 2009

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