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

NCT ID: NCT03177655

Last Updated: 2017-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-01

Study Completion Date

2017-03-01

Brief Summary

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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

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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.

Conditions

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Multiple Sclerosis (MS)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Guided Imagery

Guided Imagery meditation

Group Type EXPERIMENTAL

Guided Imagery

Intervention Type OTHER

Guided Imagery meditation

Journaling

Keeping a journal

Group Type ACTIVE_COMPARATOR

Journaling

Intervention Type OTHER

Keeping a journal

Interventions

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Guided Imagery

Guided Imagery meditation

Intervention Type OTHER

Journaling

Keeping a journal

Intervention Type OTHER

Eligibility Criteria

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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

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).
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Paul J. Mills

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of California, San Diego

San Diego, California, United States

Site Status

Countries

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United States

Other Identifiers

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121412

Identifier Type: -

Identifier Source: org_study_id

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