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Pilot Study on Sleep Management for US Veterans

A Pilot Study of Two Contrasting Intervention Programs for Sleep Management

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00933959
Enrollment
60
Registered
2009-07-08
Start date
2008-03-31
Completion date
2009-03-31
Last updated
2009-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia

Keywords

Sleep problems, Awareness training program, Mind body bridging

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).

Interventions

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

BEHAVIORALSleep Hygiene

Treatment as usual

Sponsors

University of Utah
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
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

Design outcomes

Primary

MeasureTime frame
Medical Outcomes Study-Sleep ScalePre-treatment, Week 1, Post treatment
Medical Outcomes Study Short Form-36 for VeteransPre-treatment, Post treatment

Secondary

MeasureTime frame
Center for Epidemiologic Studies Depression ScalePre-treatment, Post treatment
Five-factor Mindfulness QuestionnairePre-treatment, Post treatment
PTSD Check List-MilitaryPre-treatment, Post treatment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026