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

Insomnia Clinical Trial

Official title:

A Pilot Study of Two Contrasting Intervention Programs for Sleep Management - Part II

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00935337
• Other study ID #: 34556
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 18, 2009
• Last updated: November 23, 2011
• Start date: April 2009
• Est. completion date: September 2009

Study information

• Verified date: November 2011
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insomnia

Intervention

Behavioral:
• Mind-Body Bridging Program
Bridging aims to reduce the impact of negative thought patterns that contribute to stress in the body.
• Sleep Hygiene
treatment as usual

Locations

Country	Name	City	State
United States	SLC VA Medical Center	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medical Outcomes Study-Sleep Scale		6 months following study part I	No
Primary	Medical Outcomes Study Short Form-36		6 months following study part I	No
Secondary	Center for Epidemiologic Studies Depression Scale		6 months following study part I	No
Secondary	Five-factor Mindfulness Questionnaire		6 months following study part I	No
Secondary	PTSD Check List-Military		6 months following study part I	No