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Trial record 1 of 9 for:    Completed Studies | guided imagery | United States, California
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Effect of Guided Imagery on Well-being in Patients With Multiple Sclerosis (HLGI)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03177655
First Posted: June 6, 2017
Last Update Posted: June 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Paul J. Mills, University of California, San Diego
  Purpose
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.

Condition Intervention
Multiple Sclerosis (MS) Other: Guided Imagery Other: Journaling

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Guided Imagery on Well-being in Patients With Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Paul J. Mills, University of California, San Diego:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Mood (BDI-II) [ Time Frame: Change from baseline at 10 weeks ]
    Depressed mood based on the Beck Depression Inventory II (BDI-II)

  • Fatigue (FSS) [ Time Frame: Change from baseline at 10 weeks ]
    Fatigue levels based on the Fatigue Severity Scale (FSS)


Enrollment: 20
Actual Study Start Date: March 1, 2012
Study Completion Date: March 1, 2017
Primary Completion Date: March 1, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Guided Imagery
Guided Imagery meditation
Other: Guided Imagery
Guided Imagery meditation
Active Comparator: Journaling
Keeping a journal
Other: Journaling
Keeping a journal

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of Relapsing-Remitting Multiple Sclerosis
  2. 18-70 years old
  3. Able to read and write in English
  4. Able to attend sessions at the UC San Diego School of Medicine

    • Age group: adult
    • Gender: both
    • Target enrollment: 20

Participant exclusion criteria:

  1. Severe depression (score of 31 or higher on the BDI)
  2. Very high levels of fatigue (above an average of 6 on the FSS)
  3. Low levels of mindfulness (below an average score of 2 on the FMI).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03177655


Locations
United States, California
University of California, San Diego
San Diego, California, United States, 92103
Sponsors and Collaborators
University of California, San Diego
  More Information

Responsible Party: Paul J. Mills, Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03177655     History of Changes
Other Study ID Numbers: 121412
First Submitted: May 31, 2017
First Posted: June 6, 2017
Last Update Posted: June 6, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases