A Social Emotion Regulation Intervention in MS
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03951974|
Recruitment Status : Not yet recruiting
First Posted : May 16, 2019
Last Update Posted : May 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis Emotional Disturbances||Behavioral: Social Emotion Regulation Strategy Development Behavioral: Control||Not Applicable|
Multiple sclerosis (MS) is a progressive and debilitating neurological disease which not only affects a patient's physical health, but also adversely affects their mental health. Depressed mood is common in MS, and poor mental health in individuals with MS has wide-ranging consequences on social relationships and community integration. The preponderance of negative emotions and sparsity of positive emotions in MS are attributable in part to ineffective emotion regulation strategies. Thus, the clinical trial seeks to evaluate the effectiveness of an intervention which instructs individuals on using the social regulation of emotion.
The social regulation of emotion occurs when a one's emotional state benefits from an interaction with another person, such as when seeking comfort from a trusted friend. The current intervention was designed to leverage existing social relationships for emotional support in a manner which should strengthen the perception of social support and also reinforce existing relationships. The primary goal of this trial is to examine changes in mental well-being after treatment.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||A Social Emotion Regulation Intervention in MS|
|Estimated Study Start Date :||May 20, 2019|
|Estimated Primary Completion Date :||May 20, 2019|
|Estimated Study Completion Date :||May 20, 2019|
Participants in the experimental group will receive training in utilizing social regulation of emotion strategies in an individualized format. They will meet with an interventionist for 5 weeks (1 in-person session and 4 telephone sessions) for 1-1.5 hours each week, and keep a journal documenting their emotion challenges and regulation strategy use.
Behavioral: Social Emotion Regulation Strategy Development
Participants will work one-on-one with an interventionist to develop goals (in the form of implementation intentions) to develop social emotion regulation strategies to combat frequent emotional challenges.
Participants in the control group will not receive training in utilizing social regulation of emotion strategies. While they will still meet with the interventionist on the same schedule and for approximately the same length of time, they will simply be asked to report the emotion regulation strategies that they naturally employ. They will also keep a journal documenting their emotion challenges and regulation strategy use.
Participants will work one-on-one with an interventionist to report on their frequent emotional challenges, and report the emotion regulation strategies that they frequently use to combat them.
- Well-being: Depression [ Time Frame: Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 6) ]Change in scores on a self-report questionnaire of depression
- Well-being: Stress [ Time Frame: Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 6) ]Change in scores on a self-report questionnaire of stress
- Well-being: Quality of life [ Time Frame: Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 6) ]Change in scores on a self-report questionnaire of quality of life
- Perceived social support [ Time Frame: Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 6) ]Change in scores on a self-report questionnaire of perceived social support
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03951974
|Contact: Katie Lancaster, PhDfirstname.lastname@example.org|
|United States, New Jersey|
|Kessler Foundation||Not yet recruiting|
|East Hanover, New Jersey, United States, 07936|
|Contact: Katie Lancaster, PhD 973-324-8431 email@example.com|
|Principal Investigator:||Katie Lancaster, PhD||Kessler Foundation|