Pilot Study on Sleep Management for US Veterans

NCT ID: NCT00933959

Last Updated: 2009-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2009-03-31

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).

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).

Conditions

Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Mind-Body Bridging Program

Intervention Type: BEHAVIORAL

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

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.

Group Type: ACTIVE_COMPARATOR

Sleep Hygiene

Intervention Type: BEHAVIORAL

Treatment as usual

Interventions

Mind-Body Bridging Program

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

Intervention Type: BEHAVIORAL

Sleep Hygiene

Treatment as usual

Intervention Type: BEHAVIORAL

Other Intervention Names

MBBP; SH

Eligibility Criteria

Inclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

SLC VA Medical Center/University of Utah

Principal Investigators

Gavin West, M.D.

Role: PRINCIPAL_INVESTIGATOR

Salt Lake City VA/University of Utah

Locations

SLC VA Medical Center

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

27522

Identifier Type: -

Identifier Source: org_study_id