Multiple SclerosisTakeChargeNCT00944190
TakeCharge: Telephone Delivered Self-management Intervention for People With Multiple Sclerosis (MS)
A study testing Self-management intervention and Education in people with Multiple Sclerosis, run by University of Washington at 1 site in United States.
Trial summary
The proposed project will evaluate the efficacy of a telephone-delivered self-management (T-SM) intervention for reducing the impact of secondary conditions in persons with multiple sclerosis (MS), including chronic pain, fatigue, depression, and cognitive impairment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Self-management intervention and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Sep 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be diagnosed with MS by a physician.
- Must be at least 18 years of age.
- Must be able to understand, speak, and read English.
- Must have the presence of at least one of four common secondary conditions (fatigue, pain, depression, cognitive difficulties) that interferes with employment, participation, and functioning.
Who cannot join
- Unable to understand or read English.
- Severe cognitive impairment, defined as one or more errors on the 6-item screener, that would prevent informed consent and inability to carry on a phone conversation.
- Currently participating in regularly scheduled psychotherapy.
- Psychiatric contraindications such as current psychosis, active suicidal ideation, or current alcohol or drug use.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Telephone Delivered Self-management Intervention for People With Multiple Sclerosis Addressing Pain, Fatigue, Depression, and Cognitive Difficulties
The proposed project will evaluate the efficacy of a telephone-delivered self-management (T-SM) intervention for reducing the impact of secondary conditions in persons with multiple sclerosis (MS), including chronic pain, fatigue, depression, and cognitive impairment. It is hypothesized that if the effects of these conditions are reduced, study participants will demonstrate improved participation in the community and improved employment outcomes. This project is important because the majority of persons with MS experience one or more of the following secondary conditions: fatigue, pain, depression, and cognitive impairment. These secondary conditions are not always readily apparent and constitute what has been described by our Rehabilitation Research and Training Center as "hidden disabilities." Secondary conditions such as pain, depression, fatigue, and cognitive impairment frequently not only cause distress in their own right but also affect employment, participation, and quality of life. Having more than one often compounds the effect; the effect of all may be greater than the sum of each individually (e.g. depression can worsen fatigue, and cognitive impairment can worsen depression).
It is critical that this constellation of secondary symptoms be addressed using state of the art techniques based on self-management training and that intervention effects be documented with carefully controlled treatment efficacy studies.
- Conditions
- Multiple Sclerosis
- Being tested
- Self-management intervention, Education
- Keywords
- pain, fatigue, depression, cognitive difficulties, self-management
- Medical subject headings
- Multiple Sclerosis, Pain, Fatigue, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-management interventionBehavioural
Brief counseling technique, self-management,
EducationBehavioural
Educational information about pain, fatigue, depression, and cognitive difficulties in multiple sclerosis.
| Study group | Role | What they receive |
|---|---|---|
| Self-management Intervention | Experimental | Telephone based self management intervention targeted at pain, fatigue, depression, and cognitive difficulties. Receives: Behavioral: Self-management intervention |
| Education | Active comparator | Education about pain, fatigue, depression, and cognitive difficulties in multiple sclerosis. Receives: Behavioral: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
PHQ 9
Measured: Baseline, 5 weeks, 10 weeks, 6 months, and 12 months
Brief Pain Inventory
Measured: Baseline, 5 weeks, 10 weeks, 6 months, and 12 months
Modified Fatigue Impact Scale
Measured: Baseline, 5 weeks, 10 weeks, 6 months, 12 months
Secondary outcomes (3)
PROMIS Depression Short Form
Measured: Baseline, 5 weeks, 10 weeks, 6 months, 12 months
PROMIS Pain Impact Short Form
Measured: Baseline, 5 weeks, 10 weeks, 6 months, 12 months
PROMIS Fatigue Short Form
Measured: Baseline, 5 weeks, 10 weeks, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2009 (estimated)
- Study startOct 2009
- Primary completionDec 2012
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dawn Ehde, University of Washington
- Investigators
- Dawn Ehde, PhD, Principal investigator, University of WashingtonGeorge Kraft, MD, Study director, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00944190
- Sponsor's protocol ID
- 36021-C
- Other IDs
- H133B080025
- Acronym
- TakeCharge
- Status last verified
- Apr 2015
- First submitted
- 21 Jul 2009
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Phillips Reindel KM, Bell AS, Goldberg EL, Green C, Watson ST, Ehde DM. Exploring social moderators of telehealth treatment outcomes for adults with multiple sclerosis: A secondary analysis of a randomized controlled trial. Rehabil Psychol. 2026 Jul 9. doi: 10.1037/rep0000686. Online ahead of print.
PubMed 42423672Knowles LM, Arewasikporn A, Kratz AL, Turner AP, Alschuler KN, Ehde DM. Early Treatment Improvements in Depression Are Associated With Overall Improvements in Fatigue Impact and Pain Interference in Adults With Multiple Sclerosis. Ann Behav Med. 2021 Aug 23;55(9):833-843. doi: 10.1093/abm/kaaa102.
PubMed 33196779Ehde DM, Arewasikporn A, Alschuler KN, Hughes AJ, Turner AP. Moderators of Treatment Outcomes After Telehealth Self-Management and Education in Adults With Multiple Sclerosis: A Secondary Analysis of a Randomized Controlled Trial. Arch Phys Med Rehabil. 2018 Jul;99(7):1265-1272. doi: 10.1016/j.apmr.2017.12.012. Epub 2018 Jan 11.
PubMed 29337024Ehde DM, Elzea JL, Verrall AM, Gibbons LE, Smith AE, Amtmann D. Efficacy of a Telephone-Delivered Self-Management Intervention for Persons With Multiple Sclerosis: A Randomized Controlled Trial With a One-Year Follow-Up. Arch Phys Med Rehabil. 2015 Nov;96(11):1945-58.e2. doi: 10.1016/j.apmr.2015.07.015. Epub 2015 Aug 6.
PubMed 26254948
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telephone Delivered Self-management Intervention for People With Multiple Sclerosis Addressing Pain, Fatigue, Depression, and Cognitive Difficulties
- ClinicalTrials.gov ID
- NCT00944190
- Acronym / sponsor ID
- TakeCharge / 36021-C
- Conditions
- Multiple Sclerosis
- Keywords
- pain, fatigue, depression, cognitive difficulties, self-management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 23 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.
The proposed project will evaluate the efficacy of a telephone-delivered self-management (T-SM) intervention for reducing the impact of secondary conditions in persons with multiple sclerosis (MS), including chronic pain, fatigue, depression, and cognitive impairment. It is hypothesized that if the effects of these conditions are reduced, study participants will demonstrate improved participation in the community and improved employment outcomes. This project is important because the majority of persons with MS experience one or more of the following secondary conditions: fatigue, pain, depression, and cognitive impairment. These secondary conditions are not always readily apparent and constitute what has been described by our Rehabilitation Research and Training Center as "hidden disabilities." Secondary conditions such as pain, depression, fatigue, and cognitive impairment frequently not only cause distress in their own right but also affect employment, participation, and quality of life. Having more than one often compounds the effect; the effect of all may be greater than the sum of each individually (e.g. depression can worsen fatigue, and cognitive impairment can worsen depression).
It is critical that this constellation of secondary symptoms be addressed using state of the art techniques based on self-management training and that intervention effects be documented with carefully controlled treatment efficacy studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-management Intervention | Experimental | Behavioral: Self-management interventionTelephone based self management intervention targeted at pain, fatigue, depression, and cognitive difficulties. |
| Education | Active comparator | Behavioral: EducationEducation about pain, fatigue, depression, and cognitive difficulties in multiple sclerosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must be diagnosed with MS by a physician.
- Must be at least 18 years of age.
- Must be able to understand, speak, and read English.
- Must have the presence of at least one of four common secondary conditions (fatigue, pain, depression, cognitive difficulties) that interferes with employment, participation, and functioning.
Key exclusion criteria (4 listed)
- Unable to understand or read English.
- Severe cognitive impairment, defined as one or more errors on the 6-item screener, that would prevent informed consent and inability to carry on a phone conversation.
- Currently participating in regularly scheduled psychotherapy.
- Psychiatric contraindications such as current psychosis, active suicidal ideation, or current alcohol or drug use.
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 |
|---|---|---|
| Self-management interventionBrief counseling technique, self-management, | Behavioural | Self-management Intervention |
| EducationEducational information about pain, fatigue, depression, and cognitive difficulties in multiple sclerosis. | Behavioural | Education |
Primary outcome
PHQ 9
Time frame: Baseline, 5 weeks, 10 weeks, 6 months, and 12 months
Brief Pain Inventory
Time frame: Baseline, 5 weeks, 10 weeks, 6 months, and 12 months
Modified Fatigue Impact Scale
Time frame: Baseline, 5 weeks, 10 weeks, 6 months, 12 months
3 secondary outcomes
PROMIS Depression Short Form
Time frame: Baseline, 5 weeks, 10 weeks, 6 months, 12 months
PROMIS Pain Impact Short Form
Time frame: Baseline, 5 weeks, 10 weeks, 6 months, 12 months
PROMIS Fatigue Short Form
Time frame: Baseline, 5 weeks, 10 weeks, 6 months, 12 months
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 7 Apr 2015.
- Derived from this study: PubMed 42423672Phillips Reindel KM, Bell AS, Goldberg EL, Green C, Watson ST, Ehde DM. Exploring social moderators of telehealth treatment outcomes for adults with multiple sclerosis: A secondary analysis of a randomized controlled trial. Rehabil Psychol. 2026 Jul 9. doi: 10.1037/rep0000686. Online ahead of print.
- Derived from this study: PubMed 33196779Knowles LM, Arewasikporn A, Kratz AL, Turner AP, Alschuler KN, Ehde DM. Early Treatment Improvements in Depression Are Associated With Overall Improvements in Fatigue Impact and Pain Interference in Adults With Multiple Sclerosis. Ann Behav Med. 2021 Aug 23;55(9):833-843. doi: 10.1093/abm/kaaa102.
- Derived from this study: PubMed 29337024Ehde DM, Arewasikporn A, Alschuler KN, Hughes AJ, Turner AP. Moderators of Treatment Outcomes After Telehealth Self-Management and Education in Adults With Multiple Sclerosis: A Secondary Analysis of a Randomized Controlled Trial. Arch Phys Med Rehabil. 2018 Jul;99(7):1265-1272. doi: 10.1016/j.apmr.2017.12.012. Epub 2018 Jan 11.
- Derived from this study: PubMed 26254948Ehde DM, Elzea JL, Verrall AM, Gibbons LE, Smith AE, Amtmann D. Efficacy of a Telephone-Delivered Self-Management Intervention for Persons With Multiple Sclerosis: A Randomized Controlled Trial With a One-Year Follow-Up. Arch Phys Med Rehabil. 2015 Nov;96(11):1945-58.e2. doi: 10.1016/j.apmr.2015.07.015. Epub 2015 Aug 6.
- Webpage for MS Rehabilitation Research and Training CenterLink provided by the sponsor.
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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.
Dawn Ehde, PhD principal investigator
University of Washington
George Kraft, MD 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 Self-management intervention and Education in people with Multiple Sclerosis, 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 4 inclusion and 4 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 7 Apr 2015. 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?
PHQ 9 (time frame: Baseline, 5 weeks, 10 weeks, 6 months, and 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00944190, which also lists 4 linked publications.
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 7 Apr 2015.