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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
12-week group, adapted from Dialectical Behavior Therapy, that focuses on emotion regulation skills training and practice.
12-week group, adapted from community-based peer support groups, that focuses on participant-generated topics and facilitated discussion.
Johns Hopkins University
Baltimore, Maryland, United States
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.
Time frame: 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.
Time frame: Baseline, 13 and 26 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 13 weeks, and 26 weeks
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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.
Time frame: Baseline, 13 weeks, and 26 weeks