Emotion Regulation Skills Training for Individuals With MS and Their Support Partners
- Conditions
- Multiple Sclerosis
- Interventions
- Behavioral: PERSISTBehavioral: Facilitated Peer Support
- Registration Number
- NCT03934489
- Lead Sponsor
- Johns Hopkins University
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PERSIST PERSIST Participants will receive Partnered Emotion Regulation Skills Intervention and Support. Facilitated Peer Support Facilitated Peer Support Participants will undergo a 12-week group intervention, adapted from community-based peer support groups, that focuses on participant-generated topics and facilitated discussion.
- Primary Outcome Measures
Name Time Method Change in Depression Subscale score of the Hospital Anxiety and Depression Scale (HADS-D) Baseline, 13 and 26 weeks 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.
Change in Anxiety Subscale score of the Hospital Anxiety and Depression Scale (HADS-A) Baseline, 13 and 26 weeks 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.
- Secondary Outcome Measures
Name Time Method Change in Zarit Burden Interview (ZBI) score Baseline, 13 weeks, and 26 weeks 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.
Change in Difficulties in Emotion Regulation Scale (DERS-16) score Baseline, 13 and 26 weeks 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.
Change in Problem Solving Inventory (PSI) score Baseline, 13 and 26 weeks 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.
Change in RAND 36-Item Short Form Health Survey (SF-36) score Baseline, 13 weeks, and 26 weeks 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.
Trial Locations
- Locations (1)
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States