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NCT Number: NCT00935337

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

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.

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Parasomnias Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

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

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

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: 6 months following study part I

  2. Medical Outcomes Study Short Form-36

    Time frame: 6 months following study part I

Secondary outcomes

  1. Center for Epidemiologic Studies Depression Scale

    Time frame: 6 months following study part I

  2. Five-factor Mindfulness Questionnaire

    Time frame: 6 months following study part I

  3. PTSD Check List-Military

    Time frame: 6 months following study part I

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 - Part II

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jul 9, 2009
Registry last updated
Nov 24, 2011

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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