Multiple Sclerosis
Conditions
Keywords
Positive Psychology, Positive Affect
Brief 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. 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.
Interventions
BEHAVIORALPositive Psychology
5-week positive psychology intervention
Sponsors
Consortium of Multiple Sclerosis Centers
Massachusetts General Hospital
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
• Moderate or marked cognitive abnormalities on brief mental status testing identified that would preclude meaningful participation in the PP exercises.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of PP Exercises Completed by Subjects | Five weeks | Measured by percentage of PP exercises completed by subjects. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Affect | 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 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. |
| Change in Trait Optimism | 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. |
| Change in Depression | Five weeks | 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. |
| Change in Anxiety | Five weeks | 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. |
| Subject Ratings of Ease of Completion of PP Exercises | Five weeks | 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. |
| Change in Work Productivity | Five weeks | 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. |
| Change in Perceived Stress | Five weeks | 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. |
| Change in Resilience | Five weeks | 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. |
| Changes in Health-related Quality of Life | Five weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Subjects randomized to the intervention group will complete five weeks of positive psychology exercises, one exercise per week, during the intervention phase (weeks 1-5) of the study.
Positive Psychology: 5-week positive psychology intervention | 15 |
| Waitlist Control 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.
Positive Psychology: 5-week positive psychology intervention | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | Intervention | Total | Waitlist Control |
|---|---|---|---|
| Age, Continuous | 54.5 years STANDARD_DEVIATION 7.2 | 54.4 years STANDARD_DEVIATION 5.9 | 54.2 years STANDARD_DEVIATION 4.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 30 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 14 Participants | 29 Participants | 15 Participants |
| Region of Enrollment United States | 15 participants | 30 participants | 15 participants |
| Sex: Female, Male Female | 12 Participants | 23 Participants | 11 Participants |
| Sex: Female, Male Male | 3 Participants | 7 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
Percentage of PP Exercises Completed by Subjects
Measured by percentage of PP exercises completed by subjects.
Time frame: Five weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention | Percentage of PP Exercises Completed by Subjects | 93 percentage of exercises completed |
| Waitlist Control | Percentage of PP Exercises Completed by Subjects | 93 percentage of exercises completed |
Secondary
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.
Time frame: Five weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Change in Anxiety | State anxiety | -3.2 score on a scale | Standard Deviation 6.1 |
| Intervention | Change in Anxiety | Trait anxiety | -3.3 score on a scale | Standard Deviation 4.9 |
| Waitlist Control | Change in Anxiety | State anxiety | 3.4 score on a scale | Standard Deviation 8.1 |
| Waitlist Control | Change in Anxiety | Trait anxiety | 2.7 score on a scale | Standard Deviation 6.9 |
Secondary
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.
Time frame: Five weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Change in Depression | -2.1 score on a scale | Standard Deviation 2.9 |
| Waitlist Control | Change in Depression | 0 score on a scale | Standard Deviation 5.7 |
Secondary
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.
Time frame: Five weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Change in Perceived Stress | -0.4 units on a scale | Standard Deviation 2.8 |
| Waitlist Control | Change in Perceived Stress | -1.1 units on a scale | Standard Deviation 2.7 |
Secondary
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.
Time frame: Five weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Change in Resilience | 0.1 score on a scale | Standard Deviation 0.4 |
| Waitlist Control | Change in Resilience | -0.3 score on a scale | Standard Deviation 0.5 |
Secondary
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.
Time frame: Five weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Change in Trait Optimism | 2.1 score on a scale | Standard Deviation 3.4 |
| Waitlist Control | Change in Trait Optimism | -1.3 score on a scale | Standard Deviation 2.5 |
Secondary
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.
Time frame: Five weeks
Population: Work time missed, Work impairment and Overall work impairment are only completed by subjects who are employed. Missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Change in Work Productivity | Activity impairment | 0 score on a scale | Standard Deviation 26.9 |
| Intervention | Change in Work Productivity | Overall work impairment | 0.1 score on a scale | Standard Deviation 22.1 |
| Intervention | Change in Work Productivity | Work impairment | 1.2 score on a scale | Standard Deviation 24.7 |
| Intervention | Change in Work Productivity | Work time missed | -1.0 score on a scale | Standard Deviation 4.9 |
| Waitlist Control | Change in Work Productivity | Activity impairment | 5.0 score on a scale | Standard Deviation 23.5 |
| Waitlist Control | Change in Work Productivity | Work time missed | -1.9 score on a scale | Standard Deviation 10.8 |
| Waitlist Control | Change in Work Productivity | Work impairment | 3.3 score on a scale | Standard Deviation 10.3 |
| Waitlist Control | Change in Work Productivity | Overall work impairment | 0.5 score on a scale | Standard Deviation 15.6 |
Secondary
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.
Time frame: Five weeks
Population: Missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Changes in Affect | Positive affect | 4.9 score on a scale | Standard Deviation 4.5 |
| Intervention | Changes in Affect | Negative affect | -2.6 score on a scale | Standard Deviation 9.4 |
| Waitlist Control | Changes in Affect | Positive affect | -3.2 score on a scale | Standard Deviation 5.8 |
| Waitlist Control | Changes in Affect | Negative affect | -0.3 score on a scale | Standard Deviation 4.5 |
Secondary
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.
Time frame: Five weeks
Population: Missing data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Changes in Health-related Quality of Life | Vitality | 1.4 score on a scale | Standard Deviation 4.2 |
| Intervention | Changes in Health-related Quality of Life | Physical functioning | -1.0 score on a scale | Standard Deviation 3.3 |
| Intervention | Changes in Health-related Quality of Life | Social functioning | 3.0 score on a scale | Standard Deviation 6.7 |
| Intervention | Changes in Health-related Quality of Life | Bodily pain | 0.1 score on a scale | Standard Deviation 8.3 |
| Intervention | Changes in Health-related Quality of Life | Role emotional | -3.6 score on a scale | Standard Deviation 9.4 |
| Intervention | Changes in Health-related Quality of Life | Mental health | 2.9 score on a scale | Standard Deviation 4.6 |
| Intervention | Changes in Health-related Quality of Life | Physical component summary | 0.9 score on a scale | Standard Deviation 4.2 |
| Intervention | Changes in Health-related Quality of Life | General health | 1.1 score on a scale | Standard Deviation 4 |
| Intervention | Changes in Health-related Quality of Life | Mental component summary | 0.5 score on a scale | Standard Deviation 6 |
| Intervention | Changes in Health-related Quality of Life | Role physical | 4.2 score on a scale | Standard Deviation 6.3 |
| Waitlist Control | Changes in Health-related Quality of Life | Mental component summary | -1.4 score on a scale | Standard Deviation 6.3 |
| Waitlist Control | Changes in Health-related Quality of Life | Physical functioning | 0.3 score on a scale | Standard Deviation 3.2 |
| Waitlist Control | Changes in Health-related Quality of Life | Role physical | 1.1 score on a scale | Standard Deviation 9 |
| Waitlist Control | Changes in Health-related Quality of Life | Bodily pain | -0.2 score on a scale | Standard Deviation 7.5 |
| Waitlist Control | Changes in Health-related Quality of Life | General health | -2.9 score on a scale | Standard Deviation 3.9 |
| Waitlist Control | Changes in Health-related Quality of Life | Vitality | 0.3 score on a scale | Standard Deviation 7.7 |
| Waitlist Control | Changes in Health-related Quality of Life | Social functioning | 2.4 score on a scale | Standard Deviation 9.2 |
| Waitlist Control | Changes in Health-related Quality of Life | Mental health | -0.8 score on a scale | Standard Deviation 6.6 |
| Waitlist Control | Changes in Health-related Quality of Life | Physical component summary | 0.3 score on a scale | Standard Deviation 5.4 |
| Waitlist Control | Changes in Health-related Quality of Life | Role emotional | -4.3 score on a scale | Standard Deviation 12.3 |
Secondary
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.
Time frame: Five weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Subject Ratings of Ease of Completion of PP Exercises | Personal strengths | 8.1 score on a scale | Standard Deviation 2.2 |
| Intervention | Subject Ratings of Ease of Completion of PP Exercises | Enjoyable and meaningful activities | 9.1 score on a scale | Standard Deviation 1.5 |
| Intervention | Subject Ratings of Ease of Completion of PP Exercises | Gratitude letter | 7.8 score on a scale | Standard Deviation 1.8 |
| Intervention | Subject Ratings of Ease of Completion of PP Exercises | Remembering past successes | 8.4 score on a scale | Standard Deviation 1.3 |
| Intervention | Subject Ratings of Ease of Completion of PP Exercises | Gratitude for positive events | 9.0 score on a scale | Standard Deviation 1.3 |
| Waitlist Control | Subject Ratings of Ease of Completion of PP Exercises | Remembering past successes | 9.0 score on a scale | Standard Deviation 1.1 |
| Waitlist Control | Subject Ratings of Ease of Completion of PP Exercises | Gratitude for positive events | 8.4 score on a scale | Standard Deviation 1.9 |
| Waitlist Control | Subject Ratings of Ease of Completion of PP Exercises | Personal strengths | 7.5 score on a scale | Standard Deviation 2.2 |
| Waitlist Control | Subject Ratings of Ease of Completion of PP Exercises | Gratitude letter | 7.6 score on a scale | Standard Deviation 2.1 |
| Waitlist Control | Subject Ratings of Ease of Completion of PP Exercises | Enjoyable and meaningful activities | 8.2 score on a scale | Standard Deviation 1.7 |