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

• Sponsor: University of California, San Diego (Other)
• Overall Status: Completed
• CT.gov ID: NCT03177655
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Actual Duration (Months): 60
• Patients Per Site Per Month: 0.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis (MS)	Other: Guided Imagery; Other: Journaling	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• 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
• Actual Study Start Date: Mar 1, 2012
• Actual Primary Completion Date: Mar 1, 2017
• Actual Study Completion Date: Mar 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Guided Imagery Guided Imagery meditation	Other: Guided Imagery; Guided Imagery meditation
Active Comparator: Journaling Keeping a journal	Other: Journaling; Keeping a journal

Outcome Measures

Primary Outcome Measures

1. Quality of Life (MS-QOL-54) [Change from baseline at 10 weeks]

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

Secondary Outcome Measures

1. Mood (BDI-II) [Change from baseline at 10 weeks]

   Depressed mood based on the Beck Depression Inventory II (BDI-II)

2. Fatigue (FSS) [Change from baseline at 10 weeks]

   Fatigue levels based on the Fatigue Severity Scale (FSS)

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	University of California, San Diego	San Diego	California	United States	92103

Sponsors and Collaborators

• University of California, San Diego

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Paul J. Mills, Professor, University of California, San Diego
• ClinicalTrials.gov Identifier: NCT03177655
• Other Study ID Numbers: 121412
• First Posted: Jun 6, 2017
• Last Update Posted: Jun 6, 2017
• Last Verified: Jun 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Undecided
• 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: Multiple Sclerosis; Sclerosis

Study Results

No Results Posted as of Jun 6, 2017