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

Not Applicable

Completed

• Conditions: Multiple Sclerosis (MS)
• Interventions: Other: Guided Imagery; Other: Journaling

• Registration Number: NCT03177655
• Lead Sponsor: University of California, San Diego

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.

Study Timeline

• Study Start: 2012-03-01
• Primary Completion: 2017-03-01
• Study Completion: 2017-03-01
• Study First Submitted: 2017-05-31
• Status Verified: 2017-06
• Study First Submitted QC: 2017-06-05
• Last Update Submitted: 2017-06-05
• Study First Posted: 2017-06-06
• Last Update Posted: 2017-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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).

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Guided Imagery	Guided Imagery	Guided Imagery meditation
Journaling	Journaling	Keeping a journal

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Mood (BDI-II)	Change from baseline at 10 weeks	Depressed mood based on the Beck Depression Inventory II (BDI-II)
Fatigue (FSS)	Change from baseline at 10 weeks	Fatigue levels based on the Fatigue Severity Scale (FSS)

Trial Locations

Locations (1)

University of California, San Diego; 🇺🇸 San Diego, California, United States