Multiple SclerosisNCT03637699
A Positive Psychology Intervention for Patients With Multiple Sclerosis
A study testing Positive Psychology in people with Multiple Sclerosis, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
Positive psychology (PP) uses targeted activities to increase the frequency and intensity of positive emotional experiences such as positive affect. Examples of PP activities include recalling positive life events and performing acts of kindness. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Positive Psychology
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2018to 9 Apr 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of multiple sclerosis according to the McDonald 2010 diagnostic criteria
- Age 18-65
- Ability to speak, read and write in English
- Enrollment in the Comprehensive Longitudinal Investigation of Multiple Sclerosis at the Brigham and Women's Hospital, Partners MS Center: The CLIMB Study.
Who cannot join
- Moderate or marked cognitive abnormalities on brief mental status testing identified that would preclude meaningful participation in the PP exercises.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: A Phase I Randomized Controlled Trial of a Positive Psychology Intervention for Patients With Multiple Sclerosis
Positive psychology (PP) uses targeted activities to increase the frequency and intensity of positive emotional experiences such as positive affect. Examples of PP activities include recalling positive life events and performing acts of kindness. This pilot study will examine the tolerability and efficacy of a PP training program to increase positive affect in patients with multiple sclerosis (MS). In the intervention phase, subjects randomized to the intervention group will complete five weeks of PP exercises, one exercise per week. Subjects will also have weekly calls with the study trainer. The control group will have no study activities. In the extension phase, subjects in the control group will complete PP training as described above. The investigators will examine the tolerability of the program by calculating the proportion of subjects who complete the program. The investigators will also examine exercise-specific ratings of ease and utility to measure the acceptability of each exercise. Finally, the investigators will evaluate the efficacy of PP training by comparing subjects in the intervention and control groups on measures of positive affect, emotional function, health-related quality of life (HRQOL) and self-reported functional activities such as work. If successful, this study will advance the use of PP as a low cost, innovative and effective tool for increasing positive affect, decreasing depression and anxiety and improving HRQOL in patients with MS.
- Conditions
- Multiple Sclerosis
- Being tested
- Positive Psychology
- Keywords
- Positive Psychology, Positive Affect
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive PsychologyBehavioural
5-week positive psychology intervention
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | Subjects randomized to the intervention group will be complete five weeks of positive psychology exercises, one exercise per week, during the intervention phase (weeks 1-5) of the study. Receives: Behavioral: Positive Psychology |
| Waitlist Control | Other | Subjects randomized to the waitlist control group will complete five weeks of positive psychology exercises, one exercise per week, during the extension phase (weeks 6-10) of the study. Receives: Behavioral: Positive Psychology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of PP Exercises Completed by Subjects
Measured by percentage of PP exercises completed by subjects.
Measured: Five weeks
Secondary outcomes (9)
Subject Ratings of Ease of Completion of PP Exercises
Measured by weekly 0-10 post-exercise Likert scale ratings of ease of completion of PP exercise provided by subjects, with 0 being very difficult to complete and 10 being very easy to complete. Scores range from 0-10.
Measured: Five weeks
Changes in Affect
Measured by the Positive and Negative Affect Schedule (PANAS). PANAS is comprised of two 10-item mood scales, one measuring positive affect and the other measuring negative affect. Scores on the Positive Affect scale range from 10-50. Higher scores are associated with greater positive affect. Scores on the Negative Affect scale range from 10-50, with lower scores representing lower levels of negative affect.
Measured: Five weeks
Change in Trait Optimism
Measured by the Life Orientation Test - Revised (LOT-R). LOT-R is a 6-item measure of trait optimism and pessimism. Scores range from 0-24. Higher scores are associated with greater optimism.
Measured: Five weeks
Change in Depression
Measured by the Center for Epidemiologic Studies Depression Scale (CES-D). CES-D is a 20-item measure of depression with scores ranging from 20-80. Higher scores are associated with greater depression.
Measured: Five weeks
Change in Anxiety
Measured by the State Trait Anxiety Inventory (STAI). STAI includes two 20-item questionnaires designed to measure the current temporary condition of "state" anxiety and the more general and longstanding condition of "trait" anxiety. Scores for each scale range from 20-80. Higher scores are associated with greater anxiety.
Measured: Five weeks
Changes in Health-related Quality of Life
Measured by the Medical Outcomes Study Short Form (SF-36). The SF-36 is a 36-item measure of health status and quality of Life. It consists of eight scaled scores and two summary scores. The lower the score, the more disability. The higher the score, the less disability. Scores for each scale range from 0-100.
Measured: Five weeks
Change in Work Productivity
Measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). Outcomes are expressed as impairment percentages with higher scores indicating greater impairment and less productivity. Scores range from 0-100.
Measured: Five weeks
Change in Perceived Stress
Measured by the Perceived Stress Scale (PSS). The PSS is a 10-item questionnaire with scores ranging from 0-40. Higher scores are associated with greater perceived stress.
Measured: Five weeks
Change in Resilience
Measured by the Brief Resilience Scale (BRS). The BRS is a 6-item measure of resilience with scores ranging from 1-5. Higher scores are associated with greater resilience.
Measured: Five weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2018
- Study start12 Mar 2018
- Primary completion9 Apr 2019
- Study completion9 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Consortium of Multiple Sclerosis Centers, Massachusetts General Hospital
- Responsible party
- Principal investigator, Bonnie Ilene Glanz, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03637699
- Sponsor's protocol ID
- 2017P002375
- Status last verified
- Jul 2021
- First submitted
- 6 Aug 2018
- Last updated
- 16 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Randomized Controlled Trial of a Positive Psychology Intervention for Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03637699
- Acronym / sponsor ID
- 2017P002375
- Conditions
- Multiple Sclerosis
- Keywords
- Positive Psychology, Positive Affect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Consortium of Multiple Sclerosis Centers, Massachusetts General Hospital
- Study start
- 12 Mar 2018 (actual)
- Primary completion
- 9 Apr 2019 (actual)
- Study completion
- 9 Apr 2019 (actual)
- First posted
- 20 Aug 2018 (actual)
- Results
- Posted 16 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Positive psychology (PP) uses targeted activities to increase the frequency and intensity of positive emotional experiences such as positive affect. Examples of PP activities include recalling positive life events and performing acts of kindness. This pilot study will examine the tolerability and efficacy of a PP training program to increase positive affect in patients with multiple sclerosis (MS). In the intervention phase, subjects randomized to the intervention group will complete five weeks of PP exercises, one exercise per week. Subjects will also have weekly calls with the study trainer. The control group will have no study activities. In the extension phase, subjects in the control group will complete PP training as described above. The investigators will examine the tolerability of the program by calculating the proportion of subjects who complete the program. The investigators will also examine exercise-specific ratings of ease and utility to measure the acceptability of each exercise. Finally, the investigators will evaluate the efficacy of PP training by comparing subjects in the intervention and control groups on measures of positive affect, emotional function, health-related quality of life (HRQOL) and self-reported functional activities such as work. If successful, this study will advance the use of PP as a low cost, innovative and effective tool for increasing positive affect, decreasing depression and anxiety and improving HRQOL in patients with MS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Behavioral: Positive PsychologySubjects randomized to the intervention group will be complete five weeks of positive psychology exercises, one exercise per week, during the intervention phase (weeks 1-5) of the study. |
| Waitlist Control | Other | Behavioral: Positive PsychologySubjects randomized to the waitlist control group will complete five weeks of positive psychology exercises, one exercise per week, during the extension phase (weeks 6-10) of the study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of multiple sclerosis according to the McDonald 2010 diagnostic criteria
- Age 18-65
- Ability to speak, read and write in English
- Enrollment in the Comprehensive Longitudinal Investigation of Multiple Sclerosis at the Brigham and Women's Hospital, Partners MS Center: The CLIMB Study.
Key exclusion criteria (1 listed)
- Moderate or marked cognitive abnormalities on brief mental status testing identified that would preclude meaningful participation in the PP exercises.
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 |
|---|---|---|
| Positive Psychology5-week positive psychology intervention | Behavioural | Intervention, Waitlist Control |
Primary outcome
Percentage of PP Exercises Completed by Subjects
Time frame: Five weeks
Measured by percentage of PP exercises completed by subjects.
9 secondary outcomes
Subject Ratings of Ease of Completion of PP Exercises
Time frame: Five weeks
Changes in Affect
Time frame: Five weeks
Change in Trait Optimism
Time frame: Five weeks
Change in Depression
Time frame: Five weeks
Change in Anxiety
Time frame: Five weeks
Changes in Health-related Quality of Life
Time frame: Five weeks
Change in Work Productivity
Time frame: Five weeks
Change in Perceived Stress
Time frame: Five weeks
Change in Resilience
Time frame: Five weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive Psychology in people with Multiple Sclerosis, run by Brigham and Women's Hospital 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 1 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 16 Aug 2021. 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?
Yes. Results are posted in the registry (first posted 16 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of PP Exercises Completed by Subjects (time frame: Five weeks). 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 16 Aug 2021.