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Motivational Interviewing to Increase Physical Activity to Treat Depression in People Aging With MS or SCI (inMotion)

Primary Purpose

Multiple Sclerosis, Spinal Cord Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivational interviewing
Education
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring major depressive disorder, physical activity, aging with physical disability, motivational interviewing

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Motivational interviewing

Education

Arm Description

Motivational interviewing for people aging with multiple sclerosis or spinal cord injury to increase physical activity and decrease depression.

Education about physical activity for people aging with multiple sclerosis or spinal cord injury to decrease depression.

Outcomes

Primary Outcome Measures

HAM-D
17-item interview based depression severity measure

Secondary Outcome Measures

International Physical Activity Questionnaire
self-reported measure of weekly light, moderate and vigorous physical activity

Full Information

First Posted
July 24, 2009
Last Updated
May 2, 2017
Sponsor
University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT00947232
Brief Title
Motivational Interviewing to Increase Physical Activity to Treat Depression in People Aging With MS or SCI
Acronym
inMotion
Official Title
The Effectiveness of Physical Activity for Major Depression in People Aging With Multiple Sclerosis or Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
People aging with disabilities such as spinal cord injury (SCI) or multiple sclerosis (MS) report high rates of major depression. Depression frequently adds to the disabilities and suffering in these populations. Few definitive studies of depression treatments have been done in people with MS and none in SCI. There are several reasons to explore novel treatments for major depression in these groups. First, standard treatments, such as antidepressant medications, may not be as effective in people with neurological disabilities. Next, people with physical disabilities tend to be inactive. Lack of physical activity has been positively correlated with higher levels of depression. Longitudinal data and treatment trials suggest that increased physical activity is related to improved mood. Controlled trials show that increased exercise and physical activity can be effective treatments for major depression in nondisabled older adults. Previous research by the investigators' group suggests that people with MS are quite interested in exercise and that exercise is a safe and effective treatment for depression in younger, less disabled people with MS. Exercise may have widespread benefits for people with MS or SCI. Finally, exercise or increased physical activity represents a low cost, non-stigmatizing, highly accessible potential treatment for depression in people with physical disabilities. In this study the investigators will determine whether a relatively brief telephone-based intervention to promote physical activity is an effective treatment for major depression in people aging with MS or SCI. The investigators define "aging" as chronological age greater than 45 years old.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Spinal Cord Injury
Keywords
major depressive disorder, physical activity, aging with physical disability, motivational interviewing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
123 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Motivational interviewing
Arm Type
Experimental
Arm Description
Motivational interviewing for people aging with multiple sclerosis or spinal cord injury to increase physical activity and decrease depression.
Arm Title
Education
Arm Type
Active Comparator
Arm Description
Education about physical activity for people aging with multiple sclerosis or spinal cord injury to decrease depression.
Intervention Type
Behavioral
Intervention Name(s)
Motivational interviewing
Intervention Description
Motivational interviewing, a proven counseling method that centers on individual goals and motivations, to increase exercise and decrease depression.
Intervention Type
Behavioral
Intervention Name(s)
Education
Intervention Description
Educational intervention about the benefits of physical activity to decrease depression for people aging with multiple sclerosis or spinal cord injury.
Primary Outcome Measure Information:
Title
HAM-D
Description
17-item interview based depression severity measure
Time Frame
Baseline, weeks 4, 6, 8, 12, and 24
Secondary Outcome Measure Information:
Title
International Physical Activity Questionnaire
Description
self-reported measure of weekly light, moderate and vigorous physical activity
Time Frame
Baseline, weeks 4, 6, 8, 12, and 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Bombardier, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark Jensen, PhD
Organizational Affiliation
University of Washington
Official's Role
Study Director
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Links:
URL
http://agerrtc.washington.edu
Description
Website for the Aging Rehabilitation Research and Training Center

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Motivational Interviewing to Increase Physical Activity to Treat Depression in People Aging With MS or SCI

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