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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis; Spinal Cord Injury
• Intervention / Treatment: Behavioral: Motivational interviewing; Behavioral: Education

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.

• Study Type: Interventional
• Enrollment (Actual): 123
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Motivational interviewing; Motivational interviewing for people aging with multiple sclerosis or spinal cord injury to increase physical activity and decrease depression.	Behavioral: Motivational interviewing; Motivational interviewing, a proven counseling method that centers on individual goals and motivations, to increase exercise and decrease depression.
Active Comparator: Education; Education about physical activity for people aging with multiple sclerosis or spinal cord injury to decrease depression.	Behavioral: Education; Educational intervention about the benefits of physical activity to decrease depression for people aging with multiple sclerosis or spinal cord injury.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HAM-D	17-item interview based depression severity measure	Baseline, weeks 4, 6, 8, 12, and 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
International Physical Activity Questionnaire	self-reported measure of weekly light, moderate and vigorous physical activity	Baseline, weeks 4, 6, 8, 12, and 24

Collaborators and Investigators

• Sponsor: University of Washington
• Investigators: Study Director: Mark Jensen, PhD, University of Washington

Publications and helpful links

Helpful Links

• Website for the Aging Rehabilitation Research and Training Center

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: July 24, 2009
• First Submitted That Met QC Criteria: July 27, 2009
• First Posted (Estimate): July 28, 2009

Study Record Updates

• Last Update Posted (Actual): May 5, 2017
• Last Update Submitted That Met QC Criteria: May 2, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: physical activity; major depressive disorder; motivational interviewing; aging with physical disability
• Additional Relevant MeSH Terms: Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Multiple Sclerosis; Sclerosis; Spinal Cord Injuries
• Other Study ID Numbers: 36020-J; H133B080024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED