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

Utah System of Higher Education (USHE)

Status and phase: Completed; Phase 2

Conditions: Persian Gulf War Syndrome in Veteran; Sleep Disturbance

Treatments: Behavioral: Supportive Education; Behavioral: Mind-Body Bridging Program

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01543997

IRB00049003

Details and patient eligibility

About

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

Full 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).

Enrollment: 75 patients

Sex: All

Ages: 38 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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75 participants in 2 patient groups

Mind-Body Bridging Program

Experimental group

Description:

The Mind-Body Bridging Program (MBBP) is an awareness training program (ATP)to help individuals improve their health condition and attain a state of well-being. Bridging is the primary technique that facilitates the healing process, by bringing one back to the present moment to experience thoughts, emotions and physical sensations. Bridging aims to reduce the impact of negative thought patterns that contribute to stress in the body.

Treatment:

Behavioral: Mind-Body Bridging Program

Supportive Education

Active Comparator group

Description:

Supportive Education program will provide educational lectures on disability, sleep hygiene, and current research on depression and non-directive, supportive discussions about these topics.

Treatment:

Behavioral: Supportive Education