NCT00933959

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2009

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 8, 2009

Completed
Last Updated

July 8, 2009

Status Verified

July 1, 2009

Enrollment Period

1 year

First QC Date

June 18, 2009

Last Update Submit

July 6, 2009

Conditions

Insomnia

Keywords

Sleep problemsAwareness training programMind body bridging

Outcome Measures

Primary Outcomes (2)

  • Medical Outcomes Study-Sleep Scale

    Pre-treatment, Week 1, Post treatment

  • Medical Outcomes Study Short Form-36 for Veterans

    Pre-treatment, Post treatment

Secondary Outcomes (3)

  • Center for Epidemiologic Studies Depression Scale

    Pre-treatment, Post treatment

  • Five-factor Mindfulness Questionnaire

    Pre-treatment, Post treatment

  • PTSD Check List-Military

    Pre-treatment, Post treatment

Study Arms (2)

Mind-Body Bridging Program

EXPERIMENTAL

Subjects will undergo two approximately 1.5 hr training sessions using MBBP spaced one week apart at the VASLCHCS. Each training session will comprise a number of objectives: Session 1: 1. The patient will discover the underlying cause of the insomnia. 2. The patient will learn how to use easy to apply tools to quieten the mind to sleep soundly. Session 2: 1. The patient will learn how to reduce daytime stress. 2. The patient will experience a greater sense of self. To be maximally effective, the participant should master these objectives and practice MBBP on a daily basis. Bridging and all the other MBBP techniques can be implemented at any time throughout the day and right up to the onset of sleep.

Behavioral: Mind-Body Bridging Program

Sleep Hygiene

ACTIVE COMPARATOR

Participants in the sleep hygiene arm will receive a 1 hr class directing them to the importance of following a list of up to 15 points (tips) for getting to sleep. These points include: limiting alcohol and caffeine intake before bed, using the bed only for sleeping, and having regular bedtimes. Once the instructor has gone over this list and has described in detail each of the 15 points, the class will have an opportunity to ask questions. The participant will be encouraged to learn and practice the objectives of the sleep hygiene class on a daily basis.

Behavioral: Sleep Hygiene

Interventions

Mind-Body Bridging ProgramBEHAVIORAL

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

Also known as: MBBP
Mind-Body Bridging Program
Sleep HygieneBEHAVIORAL

Treatment as usual

Also known as: SH
Sleep Hygiene

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SLC VA Medical Center

Salt Lake City, Utah, 84148, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersParasomnias

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Gavin West, M.D.

    Salt Lake City VA/University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 18, 2009

First Posted

July 8, 2009

Study Start

March 1, 2008

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

July 8, 2009

Record last verified: 2009-07

Locations

US(1)