Multiple SclerosisinMotionNCT00947232
Motivational Interviewing to Increase Physical Activity to Treat Depression in People Aging With MS or SCI
A study testing Motivational interviewing and Education in people with Multiple Sclerosis and Spinal Cord Injury, run by University of Washington at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Multiple Sclerosis, Spinal Cord Injury
- What is being tested?
- Motivational interviewing and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Multiple Sclerosis, Spinal Cord Injury
- Being tested
- Motivational interviewing, Education
- Keywords
- major depressive disorder, physical activity, aging with physical disability, motivational interviewing
- Medical subject headings
- Multiple Sclerosis, Spinal Cord Injuries, Depressive Disorder, Major, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational interviewingBehavioural
Motivational interviewing, a proven counseling method that centers on individual goals and motivations, to increase exercise and decrease depression.
EducationBehavioural
Educational intervention about the benefits of physical activity to decrease depression for people aging with multiple sclerosis or spinal cord injury.
| Study group | Role | What they receive |
|---|---|---|
| Motivational interviewing | Experimental | Motivational interviewing for people aging with multiple sclerosis or spinal cord injury to increase physical activity and decrease depression. Receives: Behavioral: Motivational interviewing |
| Education | Active comparator | Education about physical activity for people aging with multiple sclerosis or spinal cord injury to decrease depression. Receives: Behavioral: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
HAM-D
17-item interview based depression severity measure
Measured: Baseline, weeks 4, 6, 8, 12, and 24
Secondary outcomes (1)
International Physical Activity Questionnaire
self-reported measure of weekly light, moderate and vigorous physical activity
Measured: Baseline, weeks 4, 6, 8, 12, and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2009 (estimated)
- Study startOct 2009
- Primary completionDec 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charles Bombardier, University of Washington
- Investigators
- Charles Bombardier, PhD, Principal investigator, University of WashingtonMark Jensen, PhD, Study director, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00947232
- Sponsor's protocol ID
- 36020-J
- Other IDs
- H133B080024
- Acronym
- inMotion
- Status last verified
- May 2017
- First submitted
- 24 Jul 2009
- Last updated
- 5 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Physical Activity for Major Depression in People Aging With Multiple Sclerosis or Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT00947232
- Acronym / sponsor ID
- inMotion / 36020-J
- Conditions
- Multiple Sclerosis, Spinal Cord Injury
- Keywords
- major depressive disorder, physical activity, aging with physical disability, motivational interviewing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 28 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational interviewing | Experimental | Behavioral: Motivational interviewingMotivational interviewing for people aging with multiple sclerosis or spinal cord injury to increase physical activity and decrease depression. |
| Education | Active comparator | Behavioral: EducationEducation about physical activity for people aging with multiple sclerosis or spinal cord injury to decrease depression. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational interviewingMotivational interviewing, a proven counseling method that centers on individual goals and motivations, to increase exercise and decrease depression. | Behavioural | Motivational interviewing |
| EducationEducational intervention about the benefits of physical activity to decrease depression for people aging with multiple sclerosis or spinal cord injury. | Behavioural | Education |
Primary outcome
HAM-D
Time frame: Baseline, weeks 4, 6, 8, 12, and 24
17-item interview based depression severity measure
1 secondary outcome
International Physical Activity Questionnaire
Time frame: Baseline, weeks 4, 6, 8, 12, and 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2017.
- Website for the Aging Rehabilitation Research and Training CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Bombardier, PhD principal investigator
University of Washington
Mark Jensen, PhD study director
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational interviewing and Education in people with Multiple Sclerosis and Spinal Cord Injury, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HAM-D (time frame: Baseline, weeks 4, 6, 8, 12, and 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2017; AzTrials last refreshed its copy on 6 Nov 2026.