A Positive Psychology Intervention for Patients With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

A Phase I Randomized Controlled Trial of a Positive Psychology Intervention for Patients With Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03637699
• Other study ID #: 2017P002375
• Status: Completed
• Phase: N/A
• Start date: March 12, 2018
• Est. completion date: April 9, 2019

Study information

• Verified date: July 2021
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 9, 2019
• Est. primary completion date: April 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• Positive Psychology
5-week positive psychology intervention

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Consortium of Multiple Sclerosis Centers, Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of PP Exercises Completed by Subjects	Measured by percentage of PP exercises completed by subjects.	Five weeks
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.	Five weeks
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.	Five weeks
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.	Five weeks
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.	Five weeks
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.	Five weeks
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.	Five weeks
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.	Five weeks
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.	Five weeks
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.	Five weeks