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Clinical Trials/NCT03177655
NCT03177655
Completed
Not Applicable

Effect of Guided Imagery on Well-being in Patients With Multiple Sclerosis

University of California, San Diego1 site in 1 country20 target enrollmentMarch 1, 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multiple Sclerosis (MS)
Sponsor
University of California, San Diego
Enrollment
20
Locations
1
Primary Endpoint
Quality of Life (MS-QOL-54)
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

This single-center interventional study quasi-randomly allocated patients to a guided imagery or control intervention (positive journaling). Data were analyzed with treatment allocation masked.

Detailed Description

Interventions: Participants were assigned in alternate order to 10 weekly 1-hour sessions "Healing Light Guided Imagery" or at-home positive journaling; drop-outs were replaced. Intervention Type: Behavioral Multiple sclerosis (MS) is an autoimmune disease that affects the brain and spinal cord (central nervous system). Because nerves in any part of the brain or spinal cord may be damaged, patients with multiple sclerosis can have symptoms in different parts of the body. Many Multiple Sclerosis patients suffer from depression, fatigue and anxiety in addition to physical symptoms. Drugs prescribed for MS have been shown to not improve these comorbid psychological symptoms. Researchers have shown that mindfulness-based training programs can help MS patients, but these therapies are highly resource demanding and taxing for those involved. "Healing Light" Guided Imagery (HLGI; supplementary materials) is a guided imagery therapy that simulates a self-hypnotic trance state that has been anecdotally shown to improve depression and fatigue in patients with MS in less time and with fewer support resources. The investigators plan to test whether HLGI can increase patient well-being.

Registry
clinicaltrials.gov
Start Date
March 1, 2012
End Date
March 1, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Paul J. Mills

Professor

University of California, San Diego

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of Relapsing-Remitting Multiple Sclerosis
  • 18-70 years old
  • Able to read and write in English
  • Able to attend sessions at the UC San Diego School of Medicine
  • Age group: adult
  • Gender: both
  • Target enrollment: 20
  • Participant exclusion criteria:
  • Severe depression (score of 31 or higher on the BDI)
  • Very high levels of fatigue (above an average of 6 on the FSS)

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Quality of Life (MS-QOL-54)

Time Frame: Change from baseline at 10 weeks

Quality of Life based on Multiple Sclerosis Quality of Life Instrument (MS-QOL-54)

Secondary Outcomes

  • Mood (BDI-II)(Change from baseline at 10 weeks)
  • Fatigue (FSS)(Change from baseline at 10 weeks)

Study Sites (1)

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