NCT00935337

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2009

Shorter than P25 for phase_1

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

April 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2009

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 9, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

November 24, 2011

Status Verified

November 1, 2011

Enrollment Period

5 months

First QC Date

June 18, 2009

Last Update Submit

November 23, 2011

Conditions

Insomnia

Keywords

Sleep problemsAwareness training programMind body bridging

Outcome Measures

Primary Outcomes (2)

  • Medical Outcomes Study-Sleep Scale

    6 months following study part I

  • Medical Outcomes Study Short Form-36

    6 months following study part I

Secondary Outcomes (3)

  • Center for Epidemiologic Studies Depression Scale

    6 months following study part I

  • Five-factor Mindfulness Questionnaire

    6 months following study part I

  • PTSD Check List-Military

    6 months following study part I

Study Arms (2)

Mind-Body Bridging Program

EXPERIMENTAL

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.

Behavioral: Mind-Body Bridging Program

Sleep Hygiene

ACTIVE COMPARATOR

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.

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 qualify if:

  • Have participated in Part I of this study

You may not qualify if:

  • 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 9, 2009

Study Start

April 1, 2009

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

November 24, 2011

Record last verified: 2011-11

Locations

US(1)