Exercise Training for Managing Major Depressive Disorder in Multiple Sclerosis
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 64 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study compares an exercise program called POWER-MS with a stretching program called FLEX-MS. It tests whether they reduce depression right away and over time, and improve other health measures. It is for adults ages 18 to 64 with multiple sclerosis (MS) and major depressive disorder.
The purpose of this research is to examine the effects of two different exercise training regimens for managing depression and improving other health indicators among persons with multiple sclerosis (MS). The project will enroll persons with MS and major depressive disorder (MDD) between 18 and 64 years of age. The investigators will enroll a total of 146 participants. This is a Phase-II trial that compares the efficacy of an exercise training program (POWER-MS) compared with a stretching program (FLEX-MS) for immediate and sustained reductions in the severity of depression among persons with MS who have MDD.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have a confirmed diagnosis of multiple sclerosis (MS).
- Have major depressive disorder, as confirmed by a mental health interview.
- Speak English as your main language.
- Be 18 to 64 years old.
- Have had no MS flare-ups and taken no steroids in the past 30 days.
- Have internet and email access.
- Be willing to complete tests and surveys, wear a movement tracker, be placed in a study group by chance, and do exercise testing.
Who can't join
- Score 14 or higher on the GLTEQ activity survey, meaning you are too physically active for this study.
- Score above 2 on the PDDS walking survey, meaning you have more than mild trouble walking.
- Score below 4 on the BDI-FS depression survey.
- Answer yes to more than one question on the 7-question PAR-Q exercise safety survey. This may mean exercise in this study is not safe for you.
- Score below 18 on the TICS-M phone test of memory and thinking skills.
- Have another severe mental illness found in the study interview, such as obsessive-compulsive disorder, schizophrenia, bipolar disorder, or another disorder that affects your sense of reality.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria * Physical confirmed diagnosis of Multiple Sclerosis (MS) * Diagnosis of Major Depressive Disorder (MDD) - see below (MINI) * English as primary language * Eligible age (between 18 and 64 years old) * Relapse and steroid free in past 30 days * Internet and email access * Willingness to complete the testing and questionnaires, wear the accelerometer, undergo randomization, and engage in exercise testing Exclusion Criteria * Godin Leisure Time Exercise Questionnaire (GLTEQ): Exclude if health contribution score of 14 units or more. This assessment is administered to confirm insufficient baseline physical activity (i.e., not meeting current PA guidelines) * Patient Determined Disease Steps (PDDS): Exclude if score above '2' (i.e., greater than mild ambulatory disability). This assessment is administered as the proposed intervention focuses on walking as main modality for exercise training. The scale asks the participant to describe their walking situation on a scale of 0 to 8; where lower scores indicate better walking ability. * Beck Depression Inventory-Fast Screen (BDI-FS): Exclude if a score less than '4'. The scale measures depression and those with a score of '4' or below likely have very mild depression resulting in floor effects and/or spontaneous remission. * Physical Activity Readiness Questionnaire (PAR-Q): Exclude if more than one yes/affirmative response on this 7-item self-report assessment. This assessment is administered to exclude those individuals who are at a moderate to high risk for contraindications of injury or possible death when undertaking strenuous or maximal exercise. This is a 7-item self-report tool where more than one yes/affirmative response indicates that an individual is not recommended to engage in physical activity within the capacity of this study. Those scoring more than one yes/affirmative response will be further advised to seek medical guidance before becoming more physically active. * Telephone Interview for Cognitive Status (TICS-M): Exclude if scores less than 18. This assessment is administered to ensure that all participants can adequately follow directions. The application of the TICS-M is to ensure that participants do not have severe cognitive impairment that might preclude the ability to adhere to the conditions, understand intervention content, and interact with behavior coaches. * MINI International Neuropsychiatric Interview (version 7.0.2) based on the Diagnostic and Statistical Manual of Mental Disorders V (DSM-V): Include those who meet the criteria for MDD, but exclude for other severe mental illness (obsessive-compulsive disorder, schizophrenia, bipolar or other psychotic disorders) as indicated by the MINI; these persons would require more intensive mental health treatment.
Study sites (1)
IL
- University of Illinois at Chicago · Chicago, IL 60612Robert W Motl, PhD · Study contact · 3124137850 · robmotl@uic.eduMore trials in Chicago