Clinical Benefits of a Novel Sleep-focused Mind-body Program on Gulf War Illness (GWI) Symptoms

Sleep Disturbance Clinical Trial

Official title:

Investigating Clinical Benefits of a Novel Sleep-focused Mind-body Program on Gulf War Illness (GWI) Symptoms: An Exploratory Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01543997
• Other study ID #: IRB00049003
• Status: Completed
• Phase: Phase 2
• First received: February 27, 2012
• Last updated: November 16, 2016
• Start date: January 2012
• Est. completion date: May 2016

Study information

• Verified date: November 2016
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate clinical benefits of a novel sleep-focused mind-body program on Gulf War Illness (GWI) symptoms.

Description:

This randomized study investigates whether two treatment conditions:Mind-Body Bridging (MBB) and Supportive Education (SED) are effective in improving sleep disturbance and self-reported indicators of other co-morbid symptoms in veterans with GWI. The two treatment conditions will each comprise 3 sessions of 2 hr. duration and conducted over 3 consecutive weeks (Week 1-3).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: May 2016
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 38 Years to 80 Years

Eligibility

Inclusion Criteria:

• Veteran from First Gulf War

• Suffering from sleep disturbance

• Has other chronic symptoms of Gulf War Illness:

• fatigue

• chronic headaches

• joint/muscle pain

• cognitive difficulties

• memory/concentration problems

• shortness of breath

• gastrointestinal symptoms

Exclusion Criteria:

• terminally ill

• a highly unstable medical or psychiatric condition

• Parkinson disease

• dementia of any cause

• Nocturia

• delayed/advanced sleep phase syndrome

• Narcolepsy

Study Design

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

Related Conditions & MeSH terms

• Dyssomnias
• Parasomnias
• Persian Gulf Syndrome
• Persian Gulf War Syndrome in Veteran
• Sleep Disturbance
• Sleep Wake Disorders

Intervention

Behavioral:
• Mind-Body Bridging Program
Bridging aims to reduce the impact of negative thought patterns that contribute to stress in the body.
• Supportive Education
This intervention will provide educational lectures on disability, sleep hygiene, and current research on depression and nondirective, supportive discussions about these topics.

Locations

Country	Name	City	State
United States	Pain Research Center	Salt Lake City	Utah
United States	VA SLC Health Care System	Salt Lake City	Utah

Sponsors (3)

Lead Sponsor	Collaborator
University of Utah	United States Department of Defense, VA Salt Lake City Health Care System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the measure of the Medical Outcomes Study-Sleep Scale		Week1, Week2, Week 3, Week 4, Week 15	No
Primary	Change from baseline in the measure of the Sleep Diary		Week2, Week 4, Week 15	No
Secondary	Pain	Multidimensional Pain Inventory Pain Scale	Pre (Baseline), Post (Week4), Follow-up (Week 15)	No
Secondary	Fatigue	Multidimensional Fatigue Inventory	Pre (Baseline), Post (Week4), Follow-up (Week 15)	No
Secondary	Cognitive functioning	Cognitive Failures Questionnaire	Pre (Baseline), Post (Week4), Follow-up (Week 15)	No
Secondary	Mindfulness	5-factor M questionnaire	Pre (Baseline), Weekly for 3 weeks, Post (Week4), Follow-up (Week 15)	No
Secondary	Health-related quality of life	Medical Outcomes Study Short Form-36	Pre (Baseline), Post (Week4), Follow-up (Week 15)	No
Secondary	PTSD	PTSD Check List-Military (PCL-M)	Pre (Baseline), Post (Week4), Follow-up (Week 15)	No
Secondary	Depression	Center of Epidemiological Study-Depression Scale	Pre (Baseline), Post (Week4), Follow-up (Week 15)	No
Secondary	Psychological symptoms	Brief Symptom Inventory 18	Pre (Baseline), Post (Week4), Follow-up (Week 15)	No