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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03177655
Other study ID # 121412
Secondary ID
Status Completed
Phase N/A
First received May 31, 2017
Last updated June 5, 2017
Start date March 1, 2012
Est. completion date March 1, 2017

Study information

Verified date June 2017
Source University of California, San Diego
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date March 1, 2017
Est. primary completion date March 1, 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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).

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Guided Imagery
Guided Imagery meditation
Journaling
Keeping a journal

Locations

Country Name City State
United States University of California, San Diego San Diego California

Sponsors (1)

Lead Sponsor Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Quality of Life (MS-QOL-54) Quality of Life based on Multiple Sclerosis Quality of Life Instrument (MS-QOL-54) Change from baseline at 10 weeks
Secondary Mood (BDI-II) Depressed mood based on the Beck Depression Inventory II (BDI-II) Change from baseline at 10 weeks
Secondary Fatigue (FSS) Fatigue levels based on the Fatigue Severity Scale (FSS) Change from baseline at 10 weeks
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