inMotion Clinical Study: Using Motivational Interviewing to Increase Physical Activity to Treat Depression in People Aging With MS or SCI

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Charles Bombardier, University of Washington
ClinicalTrials.gov Identifier:
NCT00947232
First received: July 24, 2009
Last updated: June 10, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Multiple Sclerosis
Spinal Cord Injury
Behavioral: Motivational interviewing
Behavioral: Education

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effectiveness of Physical Activity for Major Depression in People Aging With Multiple Sclerosis or Spinal Cord Injury

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • HAM-D [ Time Frame: Baseline, weeks 4, 6, 8, 12, and 24 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • International Physical Activity Questionnaire [ Time Frame: Baseline, weeks 4, 6, 8, 12, and 24 ] [ Designated as safety issue: No ]

Enrollment: 123
Study Start Date: October 2009
Study Completion Date: March 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00947232

Locations
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Charles Bombardier, PhD University of Washington
Study Director: Mark Jensen, PhD University of Washington
  More Information

Additional Information:
No publications provided

Responsible Party: Charles Bombardier, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT00947232     History of Changes
Other Study ID Numbers: 36020-J, H133B080024
Study First Received: July 24, 2009
Last Updated: June 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
major depressive disorder
physical activity
aging with physical disability
motivational interviewing

Additional relevant MeSH terms:
Depression
Depressive Disorder
Multiple Sclerosis
Sclerosis
Spinal Cord Injuries
Wounds and Injuries
Behavioral Symptoms
Mood Disorders
Mental Disorders
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Spinal Cord Diseases
Central Nervous System Diseases
Trauma, Nervous System

ClinicalTrials.gov processed this record on July 20, 2014