Pilot Study on Sleep Management for US Veterans

Insomnia Clinical Trial

Official title:

A Pilot Study of Two Contrasting Intervention Programs for Sleep Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00933959
• Other study ID #: 27522
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 18, 2009
• Last updated: July 6, 2009
• Start date: March 2008
• Est. completion date: March 2009

Study information

• Verified date: July 2009
• 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 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).

Description:

Participants will be randomly assigned to either MBBP or a treatment as usual sleep hygiene (SH) group. The interventions will last two weeks in which participants will attend 2 classes 1-1.5 hr each over two consecutive weeks. Assessment of the effects of the treatments will be based on self-report outcome measures; participants will complete five questionnaires approximately one week prior to the start of the interventions (pre-treatment) and one week after the second session (post-treatment). The sleep quality assessment questionnaire will be additionally completed after the first session (Week 1).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Selection of subjects will be based on the patients exhibiting sleep disturbance as assessed by a standardized sleep questionnaire. Because we are also interested in the effects of MBBP on co-morbid illnesses besides insomnia, we will include subjects that are being treated for depression, pain, and general medical conditions, except as defined as exclusion criteria. Subjects using anti-depressants, sleep and pain medications, and other medications for any condition that is not under exclusion criteria will be admitted to the study. Thus our inclusion criteria will be broader than those based on DSM-IV for primary insomnia.

2. 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.

Exclusion Criteria:

1. 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		Pre-treatment, Week 1, Post treatment	No
Primary	Medical Outcomes Study Short Form-36 for Veterans		Pre-treatment, Post treatment	No
Secondary	Center for Epidemiologic Studies Depression Scale		Pre-treatment, Post treatment	No
Secondary	Five-factor Mindfulness Questionnaire		Pre-treatment, Post treatment	No
Secondary	PTSD Check List-Military		Pre-treatment, Post treatment	No