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| ID | Type | Description | Link |
|---|---|---|---|
| PP-1804-30860 | Other Grant/Funding Number | National Multiple Sclerosis Society |
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| Name | Class |
|---|---|
| National Multiple Sclerosis Society | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PERSIST | Experimental | Participants will receive Partnered Emotion Regulation Skills Intervention and Support. |
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| Facilitated Peer Support | Active Comparator | Participants will undergo a 12-week group intervention, adapted from community-based peer support groups, that focuses on participant-generated topics and facilitated discussion. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PERSIST | Behavioral | 12-week group, adapted from Dialectical Behavior Therapy, that focuses on emotion regulation skills training and practice. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Abbey Hughes, PhD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Baltimore | Maryland | 21205 | United States |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| Facilitated Peer Support | Behavioral | 12-week group, adapted from community-based peer support groups, that focuses on participant-generated topics and facilitated discussion. |
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| 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 |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |