Multiple Sclerosis
Conditions
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).
Interventions
BEHAVIORALPERSIST
12-week group, adapted from Dialectical Behavior Therapy, that focuses on emotion regulation skills training and practice.
BEHAVIORALFacilitated Peer Support
12-week group, adapted from community-based peer support groups, that focuses on participant-generated topics and facilitated discussion.
Sponsors
National Multiple Sclerosis Society
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Outcome results
None listed