Clinical trial NCT00933959: Pilot Study on Sleep Management for US Veterans
Official title: A Pilot Study of Two Contrasting Intervention Programs for Sleep Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Insomnia
Keywords: Sleep problems
Awareness training program
Mind body bridging
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2009-07-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Medical Outcomes Study-Sleep Scale
timeFrame: Pre-treatment, Week 1, Post treatment
measure: Medical Outcomes Study Short Form-36 for Veterans
timeFrame: Pre-treatment, Post treatment
Secondary outcomes:
measure: Center for Epidemiologic Studies Depression Scale
timeFrame: Pre-treatment, Post treatment
measure: Five-factor Mindfulness Questionnaire
timeFrame: Pre-treatment, Post treatment
measure: PTSD Check List-Military
timeFrame: Pre-treatment, Post treatment
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: SLC VA Medical Center
state: Utah
Study officials:
affiliation: Salt Lake City VA/University of Utah
name: Gavin West, M.D.
role: PRINCIPAL_INVESTIGATOR
References: