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The goal of this clinical trial is to learn whether positive psychology (PP) exercises such as writing a letter of gratitude or remembering a past success can help individuals with newly diagnosed multiple sclerosis (MS) to feel more hopeful, happy, and healthy. The main questions it aims to answer are:
Participants will be randomized to the intervention or waitlist control group. There will be an intervention phase (weeks 1-5) and an extension phase (weeks 6-10). All participants will complete questionnaires at enrollment, 5 weeks and 10 weeks. They will complete 5 weeks of self-directed PP training exercises, either during the intervention phase (intervention group) or extension phase (waitlist control group) of the study.
Researchers will compare participants in the intervention and waitlist control groups at the end of the intervention phase to see if there are improvements in positive affect, emotional function and HRQOL. For subjects in the intervention group who demonstrate improvement, researchers will determine if the benefit is maintained by comparing positive affect, emotional function and HRQOL at the completion of the intervention and extension phases of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Active Comparator | Subjects randomized to the intervention group will complete questionnaires at enrollment, Week 5 and Week 10. They will also complete 5 weeks of PP exercises, one exercise per week, during the intervention phase (weeks 1-5) of the study. |
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| Waitlist Control | Placebo Comparator | Subjects randomized to the waitlist control group will complete study questionnaires at enrollment, Week 5 and Week 10. They will also complete 5 weeks of PP exercises, one exercise per week, during the extension phase (weeks 6-10) of the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Positive psychology | Behavioral | 5-week positive psychology intervention |
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of the Positive Psychology (PP) Intervention | Percentage of subjects who completed at least four of the five PP exercises. | Five weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Subject Ratings of Ease of Completion of PP Exercises | Measured by averaging the weekly 0-10 post-exercise Likert scale ratings of ease of completion of PP exercises provided by subjects with 0 being very difficult to complete and 10 being very easy to complete. | Five weeks |
| Subject Ratings of Utility of PP Exercises |
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Inclusion Criteria:
Exclusion Criteria:
• Moderate or marked cognitive abnormalities identified by the treating neurologist during routine clinical visits that would preclude meaningful participation in the PP exercises
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham MS Center | Boston | Massachusetts | 02115 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Subjects randomized to the intervention group will complete questionnaires at enrollment, Week 5 and Week 10. They will also complete 5 weeks of PP exercises, one exercise per week, during the intervention phase (weeks 1-5) of the study. Positive psychology: 5-week positive psychology intervention |
| FG001 | Waitlist Control | Subjects randomized to the waitlist control group will complete study questionnaires at enrollment, Week 5 and Week 10. They will also complete 5 weeks of PP exercises, one exercise per week, during the extension phase (weeks 6-10) of the study. Positive psychology: 5-week positive psychology intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Subjects randomized to the intervention group will complete questionnaires at enrollment, Week 5 and Week 10. They will also complete 5 weeks of PP exercises, one exercise per week, during the intervention phase (weeks 1-5) of the study. Positive psychology: 5-week positive psychology intervention |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility of the Positive Psychology (PP) Intervention | Percentage of subjects who completed at least four of the five PP exercises. | Posted | Count of Participants | Participants | Five weeks |
|
10 weeks
It does not differ from the clinicaltrials.gov definition.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | Subjects randomized to the intervention group will complete questionnaires at enrollment, Week 5 and Week 10. They will also complete 5 weeks of PP exercises, one exercise per week, during the intervention phase (weeks 1-5) of the study. Positive psychology: 5-week positive psychology intervention |
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This study had a small sample size and numerous outcome measures. This may have limited our ability to see statistically significant changes across broader health-related quality of life outcomes.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bonnie Glanz, PhD | Brigham and Women's Hospital | 617-525-6574 | bglanz@bwh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 15, 2021 | Dec 4, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D000080032 | Psychology, Positive |
| ID | Term |
|---|---|
| D011584 | Psychology |
| D001525 | Behavioral Sciences |
| D004191 | Behavioral Disciplines and Activities |
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Measured by averaging the weekly 0-10 post-exercise Likert scale ratings of utility of PP exercises provided by subjects, with 0 being not helpful and 10 being very helpful. |
| Five weeks |
| Changes in Affect From Baseline to Five Weeks | 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 form 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. | Five weeks |
| Changes in Trait Optimism From Baseline to Five Weeks | 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. | Five weeks |
| Changes in Physical, Mental and Social Health From Baseline to Five Weeks | Measured by Neuro-QoL. Neuro-QoL uses computer adaptive testing to assess 11 domains of physical, mental and social health including Ability to participate in Social Roles and Activities, Anxiety, Cognitive Function, Depression, Emotional and Behavioral Dyscontrol, Fatigue, Lower Extremity Function, Positive Affect and Well-being, Satisfaction with Social Roles and Activities, Stigma and Upper Extremity Function. Neuro-QoL generates T scores with a mean of 50 and standard deviation (SD) of 10, based on the norming sample used, for each domain. All Neuro-QoL domains are scored such that a high score reflects more of what is being measured. | Five weeks |
| Changes in Resilience From Baseline to Five Weeks | Measured by the Brief Resilience Scale (BRS). BRS is a 6-item measure of resilience with scores ranging from 1-5. Higher scores are associated with greater resilience. | Five weeks |
| Waitlist Control |
Subjects randomized to the waitlist control group will complete study questionnaires at enrollment, Week 5 and Week 10. They will also complete 5 weeks of PP exercises, one exercise per week, during the extension phase (weeks 6-10) of the study. Positive psychology: 5-week positive psychology intervention |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | Participants |
|
|
|
| Secondary | Subject Ratings of Ease of Completion of PP Exercises | Measured by averaging the weekly 0-10 post-exercise Likert scale ratings of ease of completion of PP exercises provided by subjects with 0 being very difficult to complete and 10 being very easy to complete. | Data were included from all participants who completed each exercise, even if the participant did not complete at least four of the five PP exercises required to demonstrate feasibility. | Posted | Mean | 95% Confidence Interval | score on a scale | Five weeks |
|
|
|
| Secondary | Subject Ratings of Utility of PP Exercises | Measured by averaging the weekly 0-10 post-exercise Likert scale ratings of utility of PP exercises provided by subjects, with 0 being not helpful and 10 being very helpful. | Data were included from all participants who completed each exercise, even if the participant did not complete at least four of the five PP exercises required to demonstrate feasibility. | Posted | Mean | 95% Confidence Interval | score on a scale | Five weeks |
|
|
|
| Secondary | Changes in Affect From Baseline to Five Weeks | 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 form 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Five weeks |
|
|
|
| Secondary | Changes in Trait Optimism From Baseline to Five Weeks | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Five weeks |
|
|
|
| Secondary | Changes in Physical, Mental and Social Health From Baseline to Five Weeks | Measured by Neuro-QoL. Neuro-QoL uses computer adaptive testing to assess 11 domains of physical, mental and social health including Ability to participate in Social Roles and Activities, Anxiety, Cognitive Function, Depression, Emotional and Behavioral Dyscontrol, Fatigue, Lower Extremity Function, Positive Affect and Well-being, Satisfaction with Social Roles and Activities, Stigma and Upper Extremity Function. Neuro-QoL generates T scores with a mean of 50 and standard deviation (SD) of 10, based on the norming sample used, for each domain. All Neuro-QoL domains are scored such that a high score reflects more of what is being measured. | Posted | Mean | 95% Confidence Interval | score on a scale | Five weeks |
|
|
|
| Secondary | Changes in Resilience From Baseline to Five Weeks | Measured by the Brief Resilience Scale (BRS). BRS is a 6-item measure of resilience with scores ranging from 1-5. Higher scores are associated with greater resilience. | Posted | Mean | 95% Confidence Interval | score on a scale | Five weeks |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Waitlist Control - No Intervention | Subjects randomized to the waitlist control group will complete study questionnaires at enrollment, Week 5 and Week 10. They will also complete 5 weeks of PP exercises, one exercise per week, during the extension phase (weeks 6-10) of the study. Positive psychology: 5-week positive psychology intervention | 0 | 15 | 0 | 15 | 0 | 15 |
| EG002 | Waitlist Control - Intervention | Subjects randomized to the waitlist control group will complete study questionnaires at enrollment, Week 5 and Week 10. They will also complete 5 weeks of PP exercises, one exercise per week, during the extension phase (weeks 6-10) of the study. Positive psychology: 5-week positive psychology intervention | 0 | 15 | 0 | 15 | 0 | 15 |
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Changes in Neuro-QoL Lower Extremity Function |
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| Changes in Neuro-QoL Positive Affect |
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| Changes in Neuro-QoL Satisfaction with Social Roles |
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| Changes in Neur-QoL Upper Extremity Function |
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| Changes in Neuro-QoL Anxiety |
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| Changes in Neuro-QoL Depression |
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| Changes in Neuro-QoL Emotional and Behavioral Dyscontrol |
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| Changes in Neuro-QoL Fatigue |
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| Changes in Neuro-QoL Stigma |
|