Clinical trial NCT01453647: Study to Explore the Relationships Among Immunity and Stress and the Symptoms of Fatigue, Pain, and Mood Following Guided Imagery in Women With Fibromyalgia
Official title: Self-Efficacy, Stress, Immunity and Symptoms of Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Fibromyalgia
self-efficacy
fatigue
stress
cytokine
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2011-10-18
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This project will be the first known to explore the relationships among immunity and stress and the symptoms of fatigue, pain, and mood following guided imagery in women with fibromyalgia. Finding ways to reduce these unpleasant symptoms may lead to improved function and well-being in this chronic disorder.

Detailed description: Fibromyalgia (FM) is a chronic widespread pain and fatigue syndrome that affects 3 to 6 million adults in the United States. Consequences of FM include physical and psychological distress, loss of work productivity, reduced quality of life, and increased use of health resources. Although the mechanisms underlying the symptomatology of FM are not clear; one theory suggests potential alterations in cytokine balance. Because the symptoms of FM may be worsened by stress and negative psychological processes, mind-body modalities may positively influence the neuroendocrine and immunological mediators of symptoms in FM. Given that immune modulation by both psychosocial stressors and interventions has been linked to health changes, self-efficacy (i.e., the belief that one can cope), may be one mechanism affecting FM outcomes. The specific aims of this project are: (1) to test the effects of a 10-week guided imagery intervention in comparison to an attention control group among women diagnosed with fibromyalgia on (a) the primary outcomes of self-efficacy for managing symptoms and perceived stress and (b) the secondary outcomes of symptoms of fatigue, pain, distressed mood, and depressive symptoms and markers of immune function; and (2) to examine the relationships among self-efficacy for managing symptoms, perceived stress, symptoms of fatigue, pain, distressed mood, and depressive symptoms and markers of immune function. The biobehavioral framework to guide this project is adapted from psychoneuroimmunology. Using a randomized controlled two-group design with repeated measures, 72 individuals will be recruited and randomized into one of two groups: Usual Care plus guided imagery (GI) intervention (Group 1) or Usual Care alone (i.e., attention control group) (Group 2). The intervention consists of three 30-minute guided imagery audio recordings to be used in a proscribed manner over a 10-week period. An ANCOVA model will be used to test for group differences between the intervention and standard care groups at week 10. This project will be the first known to explore the relationships among cytokines and perceived stress and the symptoms of fatigue, pain and mood following the administration of a biobehavioral intervention in women with FM.

Eligibility criteria: Inclusion Criteria:

* ages 18 and older
* female
* diagnosis of FM based on the American College of Rheumatology criteria and documented by the patient's primary physician
* no known major psychiatric or neurological conditions that would interfere with project participation
* able to speak and read standard English
* a minimum of a 6th grade education level
* an ability to understand and sign the consent form and understand and complete the pencil and paper assignments

Exclusion Criteria:

* presence of other systemic rheumatologic conditions such as rheumatoid arthritis, systemic lupus erythematosus, and/or Sjogren's Disease
* history of epilepsy
* any present psychiatric disorder involving a history of psychosis (e.g., schizophrenia, schizoaffective disorder; schizophreniform disorder, delusional disorder, etc.)
* being immunocompromised
* receiving corticosteroid treatments
* being pregnant

Primary outcomes:
measure: Fatigue
timeFrame: baseline
measure: Fatigue
timeFrame: 6th weeks
measure: Fatigue
timeFrame: 10th week
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Common Wealth University Health System
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Victoria Menzies, PhD, APRN-BC
role: PRINCIPAL_INVESTIGATOR
References: