NCT03177655

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 6, 2017

Completed
Last Updated

June 6, 2017

Status Verified

June 1, 2017

Enrollment Period

5 years

First QC Date

May 31, 2017

Last Update Submit

June 5, 2017

Conditions

Multiple Sclerosis (MS)

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Mood (BDI-II)

    Change from baseline at 10 weeks

  • Fatigue (FSS)

    Change from baseline at 10 weeks

Study Arms (2)

Guided Imagery

EXPERIMENTAL

Guided Imagery meditation

Other: Guided Imagery

Journaling

ACTIVE COMPARATOR

Keeping a journal

Other: Journaling

Interventions

Guided ImageryOTHER

Guided Imagery meditation

Guided Imagery
JournalingOTHER

Keeping a journal

Journaling

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Relapsing-Remitting Multiple Sclerosis
  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Diego

San Diego, California, 92103, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Imagery, Psychotherapy

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 31, 2017

First Posted

June 6, 2017

Study Start

March 1, 2012

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

June 6, 2017

Record last verified: 2017-06

Locations

US(1)