Motivational Interviewing to Increase Physical Activity to Treat Depression in People Aging With MS or SCI
inMotion
The Effectiveness of Physical Activity for Major Depression in People Aging With Multiple Sclerosis or Spinal Cord Injury
2 other identifiers
interventional
123
1 country
1
Brief Summary
This study compares two approaches to helping people who are aging with MS or SCI and are experiencing depressed mood to become more physically active. The study is carried out entirely by telephone. There is no need to travel and participants may reside anywhere within the United States. We will examine the effects of the intervention on overall physical activity, mood, pain, fatigue and general health. Participants will complete surveys over the phone throughout the study and wear an activity monitor 3 times. The study is 6 months in length and participants may receive up to $120 for their time and effort.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable multiple-sclerosis
Started Oct 2009
Longer than P75 for not_applicable multiple-sclerosis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 24, 2009
CompletedFirst Posted
Study publicly available on registry
July 28, 2009
CompletedStudy Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedMay 5, 2017
May 1, 2017
3.2 years
July 24, 2009
May 2, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
HAM-D
17-item interview based depression severity measure
Baseline, weeks 4, 6, 8, 12, and 24
Secondary Outcomes (1)
International Physical Activity Questionnaire
Baseline, weeks 4, 6, 8, 12, and 24
Study Arms (2)
Motivational interviewing
EXPERIMENTALMotivational interviewing for people aging with multiple sclerosis or spinal cord injury to increase physical activity and decrease depression.
Education
ACTIVE COMPARATOREducation about physical activity for people aging with multiple sclerosis or spinal cord injury to decrease depression.
Interventions
Motivational interviewing, a proven counseling method that centers on individual goals and motivations, to increase exercise and decrease depression.
Educational intervention about the benefits of physical activity to decrease depression for people aging with multiple sclerosis or spinal cord injury.
Eligibility Criteria
You may qualify if:
- aged at least 45 years old
- self-report diagnosis of MS or SCI
- meeting SCID requirements for Major Depressive Disorder (MDD) or dysthymia
- MS: EDSS between 4.0 and 8.0
- SCI: ASIA A-D injury level at or below C4 and they have upper extremity function sufficient to propel a manual wheelchair
- meeting PHQ-9 measure cut-off for depression by scoring more than 10 on the measure
- currently inactive (exercising less than 150 minutes per week)
- response form received from participants' doctor declaring exercise safe for the subject.
You may not qualify if:
- significant cognitive impairment
- pressure ulcers on sitting surfaces (or another condition that precludes sitting
- significant obesity (\>160% of ideal body weight)
- significant risk factors for beginning moderate physical activity measured with the PAR-Q
- response form received from participants' doctor declaring exercise unsafe for the subject
- a self-reported history of significant Uthoff's effect for those with MS
- psychiatric contraindications such as bipolar disorder, psychosis, active suicidal ideation with intent or plan, or current alcohol or drug dependence. We will include people who remain depressed but are on stable doses of antidepressant medications.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Washington
Seattle, Washington, 98195, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Charles Bombardier, PhD
University of Washington
- STUDY DIRECTOR
Mark Jensen, PhD
University of Washington
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 24, 2009
First Posted
July 28, 2009
Study Start
October 1, 2009
Primary Completion
December 1, 2012
Study Completion
March 1, 2013
Last Updated
May 5, 2017
Record last verified: 2017-05