NCT00947232

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P75+ for not_applicable multiple-sclerosis

Timeline
Completed

Started Oct 2009

Longer than P75 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 28, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

May 5, 2017

Status Verified

May 1, 2017

Enrollment Period

3.2 years

First QC Date

July 24, 2009

Last Update Submit

May 2, 2017

Conditions

Keywords

major depressive disorderphysical activityaging with physical disabilitymotivational interviewing

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

EXPERIMENTAL

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

Behavioral: Motivational interviewing

Education

ACTIVE COMPARATOR

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

Behavioral: Education

Interventions

Motivational interviewing, a proven counseling method that centers on individual goals and motivations, to increase exercise and decrease depression.

Motivational interviewing
EducationBEHAVIORAL

Educational intervention about the benefits of physical activity to decrease depression for people aging with multiple sclerosis or spinal cord injury.

Education

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

Related Links

MeSH Terms

Conditions

Multiple SclerosisSpinal Cord InjuriesDepressive Disorder, MajorMotor Activity

Interventions

Motivational InterviewingEducational Status

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesSpinal Cord DiseasesCentral Nervous System DiseasesTrauma, Nervous SystemWounds and InjuriesDepressive DisorderMood DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and ServicesSocioeconomic FactorsPopulation Characteristics

Study Officials

  • Charles Bombardier, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR
  • Mark Jensen, PhD

    University of Washington

    STUDY DIRECTOR

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

Locations