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

Primary Purpose

Multiple Sclerosis (MS)

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Guided Imagery
Journaling
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis (MS)

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • University of California, San Diego

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Guided Imagery

Journaling

Arm Description

Guided Imagery meditation

Keeping a journal

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Mood (BDI-II)
Depressed mood based on the Beck Depression Inventory II (BDI-II)
Fatigue (FSS)
Fatigue levels based on the Fatigue Severity Scale (FSS)

Full Information

First Posted
May 31, 2017
Last Updated
June 5, 2017
Sponsor
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT03177655
Brief Title
Effect of Guided Imagery on Well-being in Patients With Multiple Sclerosis
Acronym
HLGI
Official Title
Effect of Guided Imagery on Well-being in Patients With Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
March 1, 2012 (Actual)
Primary Completion Date
March 1, 2017 (Actual)
Study Completion Date
March 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis (MS)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Guided Imagery
Arm Type
Experimental
Arm Description
Guided Imagery meditation
Arm Title
Journaling
Arm Type
Active Comparator
Arm Description
Keeping a journal
Intervention Type
Other
Intervention Name(s)
Guided Imagery
Intervention Description
Guided Imagery meditation
Intervention Type
Other
Intervention Name(s)
Journaling
Intervention Description
Keeping a journal
Primary Outcome Measure Information:
Title
Quality of Life (MS-QOL-54)
Description
Quality of Life based on Multiple Sclerosis Quality of Life Instrument (MS-QOL-54)
Time Frame
Change from baseline at 10 weeks
Secondary Outcome Measure Information:
Title
Mood (BDI-II)
Description
Depressed mood based on the Beck Depression Inventory II (BDI-II)
Time Frame
Change from baseline at 10 weeks
Title
Fatigue (FSS)
Description
Fatigue levels based on the Fatigue Severity Scale (FSS)
Time Frame
Change from baseline at 10 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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) Low levels of mindfulness (below an average score of 2 on the FMI).
Facility Information:
Facility Name
University of California, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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