Emotion Regulation Skills Training for Individuals With MS and Their Support Partners

Study Overview
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Brief Summary
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This pilot randomized controlled trial investigates a novel, group-based emotion regulation skills training intervention for reducing anxious and depressive symptomatology and improving emotion regulation and problem solving in individuals with MS and the individual's support partners. Participants will be randomized (1:1) to the intervention (Partnered Emotion Regulation Skills Intervention and Supportive Teaching [PERSIST]) or to the active control (Facilitated Peer Support).

Official Title
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Reducing Depression and Anxiety in Individuals With Multiple Sclerosis (MS) and Their Support Partners: An Emotion Regulation Skills Training Intervention

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Behavioral: PERSIST
* Behavioral: Facilitated Peer Support


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: at least 18 years old able to speak/read in English able to commit to attending at least 9 of the 12 weekly group sessions individuals with MS must be relapse/exacerbation-free for at least 1 month support partners must score at least 8 on the HADS-D or HADS-A individuals with MS must score a least 11 on the HADS-D or HADS-A Exclusion Criteria: under 18 years old unable to speak/read in English unable to commit to attending at least 9 of the 12 weekly group sessions MS relapse within 1 month

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PERSIST<br>Participants will receive Partnered Emotion Regulation Skills Intervention and Support. | Behavioral: PERSIST<br>* 12-week group, adapted from Dialectical Behavior Therapy, that focuses on emotion regulation skills training and practice.<br>|
| Active Comparator: Facilitated Peer Support<br>Participants will undergo a 12-week group intervention, adapted from community-based peer support groups, that focuses on participant-generated topics and facilitated discussion. | Behavioral: Facilitated Peer Support<br>* 12-week group, adapted from community-based peer support groups, that focuses on participant-generated topics and facilitated discussion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Depression Subscale score of the Hospital Anxiety and Depression Scale (HADS-D) | The HADS-D is a 7-item subscale of the HADS that measures depressive symptomatology. Scores range from 0 to 21 points (each item is rated 0-4), with higher scores indicating greater depressive symptomatology. | Baseline, 13 and 26 weeks | 
| Change in Anxiety Subscale score of the Hospital Anxiety and Depression Scale (HADS-A) | The HADS-A is a 7-item subscale of the HADS that measures anxious symptomatology. Scores range from 0 to 21 points (each item is rated 0-4), with higher scores indicating greater anxious symptomatology. | Baseline, 13 and 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Difficulties in Emotion Regulation Scale (DERS-16) score | The DERS-16 is a 16-item self-report measures that assesses difficulties with managing negative emotions, distress, and impulsivity. Scores range from 16 to 80 points (each item is rated 1-5), with higher scores indicating greater emotional dysregulation. | Baseline, 13 and 26 weeks | 
| Change in Problem Solving Inventory (PSI) score | The PSI is a 32-item self-report instrument designed to assess perceived problem solving abilities. Scores range from 32 to 192 points (each item is rated 1-6), with higher scores indicating greater difficulty with problem solving. | Baseline, 13 and 26 weeks | 
| Change in RAND 36-Item Short Form Health Survey (SF-36) score | The SF-36 is a 36-item self-report measure of health-related quality of life. The scale is divided into 8 subscales, each ranging from 0 to 100 points, with higher scores indicating better health-related quality of life. | Baseline, 13 weeks, and 26 weeks | 
| Change in Zarit Burden Interview (ZBI) score | The ZBI is a 22-item self-report measure of caregiver burden. Scores range from 0 to 88 (each item is rated 0-4), with higher scores indicating greater burden. | Baseline, 13 weeks, and 26 weeks |