Multiple SclerosisNCT03934489
Emotion Regulation Skills Training for Individuals With MS and Their Support Partners
A study testing PERSIST and Facilitated Peer Support in people with Multiple Sclerosis, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- PERSIST and Facilitated Peer Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2020to 15 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reducing Depression and Anxiety in Individuals With Multiple Sclerosis (MS) and Their Support Partners: An Emotion Regulation Skills Training Intervention
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).
- Conditions
- Multiple Sclerosis
- Being tested
- PERSIST, Facilitated Peer Support
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PERSISTBehavioural
12-week group, adapted from Dialectical Behavior Therapy, that focuses on emotion regulation skills training and practice.
Facilitated Peer SupportBehavioural
12-week group, adapted from community-based peer support groups, that focuses on participant-generated topics and facilitated discussion.
| Study group | Role | What they receive |
|---|---|---|
| PERSIST | Experimental | Participants will receive Partnered Emotion Regulation Skills Intervention and Support. Receives: Behavioral: PERSIST |
| 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. Receives: Behavioral: Facilitated Peer Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 13 and 26 weeks
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 13 weeks, and 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2019
- Study start7 Jan 2020
- Primary completion15 Mar 2021
- Study completion15 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Multiple Sclerosis Society
- Responsible party
- Sponsor
- Investigators
- Abbey Hughes, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03934489
- Sponsor's protocol ID
- IRB00199623
- Other IDs
- PP-1804-30860
- Status last verified
- Mar 2021
- First submitted
- 29 Apr 2019
- Last updated
- 24 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Depression and Anxiety in Individuals With Multiple Sclerosis (MS) and Their Support Partners: An Emotion Regulation Skills Training Intervention
- ClinicalTrials.gov ID
- NCT03934489
- Acronym / sponsor ID
- IRB00199623
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Multiple Sclerosis Society
- Study start
- 7 Jan 2020 (actual)
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- 15 Mar 2021 (actual)
- First posted
- 2 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PERSIST | Experimental | Behavioral: PERSISTParticipants will receive Partnered Emotion Regulation Skills Intervention and Support. |
| Facilitated Peer Support | Active comparator | Behavioral: Facilitated Peer SupportParticipants will undergo a 12-week group intervention, adapted from community-based peer support groups, that focuses on participant-generated topics and facilitated discussion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PERSIST12-week group, adapted from Dialectical Behavior Therapy, that focuses on emotion regulation skills training and practice. | Behavioural | PERSIST |
| Facilitated Peer Support12-week group, adapted from community-based peer support groups, that focuses on participant-generated topics and facilitated discussion. | Behavioural | Facilitated Peer Support |
Primary outcome
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.
4 secondary outcomes
Change in Difficulties in Emotion Regulation Scale (DERS-16) score
Time frame: Baseline, 13 and 26 weeks
Change in Problem Solving Inventory (PSI) score
Time frame: Baseline, 13 and 26 weeks
Change in RAND 36-Item Short Form Health Survey (SF-36) score
Time frame: Baseline, 13 weeks, and 26 weeks
Change in Zarit Burden Interview (ZBI) score
Time frame: Baseline, 13 weeks, and 26 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abbey Hughes, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PERSIST and Facilitated Peer Support in people with Multiple Sclerosis, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Depression Subscale score of the Hospital Anxiety and Depression Scale (HADS-D) (time frame: Baseline, 13 and 26 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2021.