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Follow-up of a Study Examining Sleep Management in United States Veterans

NCT ID: NCT00935337

Last Updated: 2011-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2009-09-30

Brief Summary

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The first part of the pilot study, as detailed in Unique Protocol ID No. 27522, is a randomized clinical trial that compares the effects of a mind-body bridging program with a sleep hygiene program to improve sleep quality in patients suffering from sleep disturbances. In Part II of the study, the investigators will perform a six month follow-up on the same subjects.

Detailed Description

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In this follow-up, we ask subjects to answer the same questionnaires that they completed at the beginning of the study. In addition we will ask subjects to complete a survey reflecting their medical history over the past 6 months and a second survey establishing their behavioral patterns and whether they continued practicing techniques of the intervention they were assigned to.

Conditions

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Insomnia

Keywords

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Sleep problems Awareness training program Mind body bridging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Mind-Body Bridging Program

Mind Body Bridging subjects will be accessed with questionnaires and medical history evaluations for the impact of MBBP over the past 6 months since undertaking the program.

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

Sleep Hygiene subjects will be accessed with questionnaires and medical history evaluations for the impact of SH over the past 6 months since undertaking the program.

Group Type ACTIVE_COMPARATOR

Sleep Hygiene

Intervention Type BEHAVIORAL

treatment as usual

Interventions

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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

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MBBP SH

Eligibility Criteria

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Inclusion Criteria

* Have participated in Part I of this study

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Utah

OTHER

Sponsor Role lead

Responsible Party

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VA Medical Center/University of Utah

Principal Investigators

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Gavin West, M.D.

Role: PRINCIPAL_INVESTIGATOR

Salt Lake City VA/University of Utah

Locations

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SLC VA Medical Center

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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34556

Identifier Type: -

Identifier Source: org_study_id