A Positive Psychology Intervention for Patients With Multiple Sclerosis

• ClinicalTrials.gov Identifier: NCT03637699
• Recruitment Status: Completed
• First Posted: August 20, 2018
• Results First Posted: August 16, 2021
• Last Update Posted: August 16, 2021
• Sponsor: Brigham and Women's Hospital
• Collaborators: Consortium of Multiple Sclerosis Centers; Massachusetts General Hospital
• Information provided by (Responsible Party): Bonnie Ilene Glanz, Brigham and Women's Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Multiple Sclerosis	Behavioral: Positive Psychology	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase I Randomized Controlled Trial of a Positive Psychology Intervention for Patients With Multiple Sclerosis
• Actual Study Start Date: March 12, 2018
• Actual Primary Completion Date: April 9, 2019
• Actual Study Completion Date: April 9, 2019

Arms and Interventions

Arm	Intervention/treatment
Intervention; 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.	Behavioral: Positive Psychology; 5-week positive psychology intervention
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.	Behavioral: Positive Psychology; 5-week positive psychology intervention

Outcome Measures

Primary Outcome Measures :

1. Percentage of PP Exercises Completed by Subjects [ Time Frame: Five weeks ]
   Measured by percentage of PP exercises completed by subjects.

Secondary Outcome Measures :

1. Subject Ratings of Ease of Completion of PP Exercises [ Time Frame: 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.
2. Changes in Affect [ Time Frame: 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.
3. Change in Trait Optimism [ Time Frame: 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.
4. Change in Depression [ Time Frame: 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.
5. Change in Anxiety [ Time Frame: 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.
6. Changes in Health-related Quality of Life [ Time Frame: 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.
7. Change in Work Productivity [ Time Frame: 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.
8. Change in Perceived Stress [ Time Frame: 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.
9. Change in Resilience [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, Massachusetts

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Brigham and Women's Hospital

Consortium of Multiple Sclerosis Centers

Massachusetts General Hospital

  Study Documents (Full-Text)

Documents provided by Bonnie Ilene Glanz, Brigham and Women's Hospital:

Study Protocol and Statistical Analysis Plan  [PDF] February 14, 2018

More Information

• Responsible Party: Bonnie Ilene Glanz, Research Associate, Brigham and Women's Hospital
• ClinicalTrials.gov Identifier: NCT03637699
• Other Study ID Numbers: 2017P002375
• First Posted: August 20, 2018
• Results First Posted: August 16, 2021
• Last Update Posted: August 16, 2021
• Last Verified: July 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bonnie Ilene Glanz, Brigham and Women's Hospital:

Positive Psychology; Positive Affect

Additional relevant MeSH terms:

Multiple Sclerosis; Sclerosis; Pathologic Processes; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases