NCT01453647

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 12, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 18, 2011

Completed
Last Updated

October 18, 2011

Status Verified

October 1, 2011

Enrollment Period

10 months

First QC Date

August 12, 2011

Last Update Submit

October 13, 2011

Conditions

Fibromyalgia

Keywords

Fibromyalgiaself-efficacyfatiguestresscytokine

Outcome Measures

Primary Outcomes (3)

  • Fatigue

    Measured by Multidimensional Fatigue Symptom Inventory-Short Form(MFSI-SF), PROMIS Fatigue Short-Form, and Brief Fatigue Invebtory (BFI) and 17 cytokines

    baseline

  • Fatigue

    Measured by Multidimensional Fatigue Symptom Inventory-Short Form(MFSI-SF), PROMIS Fatigue Short-Form, and Brief Fatigue Invebtory (BFI) and 17 cytokines

    6th weeks

  • Fatigue

    Measured by Multidimensional Fatigue Symptom Inventory-Short Form(MFSI-SF), PROMIS Fatigue Short-Form, and Brief Fatigue Invebtory (BFI) and 17 cytokines

    10th week

Study Arms (2)

Guided Imagery

EXPERIMENTAL

The intervention consists of three audio-recorded guided imagery scripts formatted as three separate tracks on one CD. Each track is 30 minutes in length and is to be used in a recommended order for the first 6 weeks of the intervention and then used in any order for the follow-up weeks, 7 through 10. Project participants will be instructed to use each CD track, as prescribed, a minimum of once daily. CD Track 1 is a basic relaxation entrainment script; CD track 2 is a pleasant scene imagery script; CD track 3 is a well body imagery script.

Other: Guided Imagery

control

NO INTERVENTION

Participants in the control group will be instructed to maintain their FM treatment regimens as reported at baseline.

Interventions

Guided ImageryOTHER

The intervention consists of three audio-recorded guided imagery scripts formatted as three separate tracks on one CD. Each track is 30 minutes in length and is to be used in a recommended order for the first 6 weeks of the intervention and then used in any order for the follow-up weeks, 7 through 10. Project participants will be instructed to use each CD track, as prescribed, a minimum of once daily. CD Track 1 is a basic relaxation entrainment script; CD track 2 is a pleasant scene imagery script; CD track 3 is a well body imagery script.

Guided Imagery

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Common Wealth University Health System

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

FibromyalgiaFatigue

Interventions

Imagery, Psychotherapy

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Victoria Menzies, PhD, APRN-BC

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2011

First Posted

October 18, 2011

Study Start

January 1, 2010

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

October 18, 2011

Record last verified: 2011-10

Locations

US(1)