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

Multiple Sclerosis Clinical Trial

— inMotion  

Official title:

The Effectiveness of Physical Activity for Major Depression in People Aging With Multiple Sclerosis or Spinal Cord Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00947232
• Other study ID #: 36020-J
• Secondary ID: H133B080024
• Status: Completed
• Phase: N/A
• First received: July 24, 2009
• Last updated: May 2, 2017
• Start date: October 2009
• Est. completion date: March 2013

Study information

• Verified date: May 2017
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: March 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Multiple Sclerosis
• Sclerosis
• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Behavioral:
• Motivational interviewing
Motivational interviewing, a proven counseling method that centers on individual goals and motivations, to increase exercise and decrease depression.
• Education
Educational intervention about the benefits of physical activity to decrease depression for people aging with multiple sclerosis or spinal cord injury.

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HAM-D	17-item interview based depression severity measure	Baseline, weeks 4, 6, 8, 12, and 24
Secondary	International Physical Activity Questionnaire	self-reported measure of weekly light, moderate and vigorous physical activity	Baseline, weeks 4, 6, 8, 12, and 24

External Links

•   Website for the Aging Rehabilitation Research and Training Center