Reducing Depression and Anxiety in Individuals With Multiple Sclerosis (MS) and Their Support Partners: An Emotion Regulation Skills Training Intervention
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Multiple Sclerosis
- Sponsor
- Johns Hopkins University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Change in Depression Subscale score of the Hospital Anxiety and Depression Scale (HADS-D)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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).
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Change in Depression Subscale score of the Hospital Anxiety and Depression Scale (HADS-D)
Time Frame: 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)
Time Frame: 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 Outcomes
- Change in Zarit Burden Interview (ZBI) score(Baseline, 13 weeks, and 26 weeks)
- Change in Difficulties in Emotion Regulation Scale (DERS-16) score(Baseline, 13 and 26 weeks)
- Change in Problem Solving Inventory (PSI) score(Baseline, 13 and 26 weeks)
- Change in RAND 36-Item Short Form Health Survey (SF-36) score(Baseline, 13 weeks, and 26 weeks)