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OpenTrials
Completed

NCT Number: NCT00933959

Pilot Study on Sleep Management for US Veterans

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).

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

SLC VA Medical Center

Salt Lake City, Utah, 84148, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mind-Body Bridging Program

Behavioral

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

Other names: MBBP

Sleep Hygiene

Behavioral

Treatment as usual

Other names: SH

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

A Pilot Study of Two Contrasting Intervention Programs for Sleep Management

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jul 8, 2009
Registry last updated
Jul 8, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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