Multiple SclerosisPrEliMS2NCT05225012
Providing Emotional Support Around the Point of Multiple Sclerosis Diagnosis: PrEliMS 2
A study testing Acceptance and Commitment Therapy in people with Multiple Sclerosis, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
Emotional support following Multiple Sclerosis (MS) diagnosis is not part of the current service provision. However, research has identified a need for this as poor adjustment to diagnosis has been linked to higher levels of psychological distress. 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?
- Acceptance and Commitment Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Aug 2022to 30 Jun 2023
- 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
- Aged 18 and/or over.
- Received a new diagnosis of MS within the last twelve months, confirmed by a Consultant Neurologist.
- Scores ≥18 on the MSIS-Psy.
Who cannot join
- Unable or willing to give informed consent.
- Individuals currently receiving psychological therapy, to ensure any change cannot be attributed to another intervention.
- Individuals who have had a prior diagnosis of psychological distress, e.g., Depression or Anxiety Disorder, to ensure participants are as homogenous as possible. The intervention is aimed at distress specifically related to receiving an MS diagnosis.
- Unable to speak and read English (as all measure used have been standardised and validated in English, and the workbook is only available in English).
- Unable to use/do not have access to a telephone or a computer with internet connection
Trial locations and contacts
1 site in 1 country.
About this study
Emotional support following Multiple Sclerosis (MS) diagnosis is not part of the current service provision. However, research has identified a need for this as poor adjustment to diagnosis has been linked to higher levels of psychological distress. A previous study, named 'Providing Emotional Support Around the Point of MS Diagnosis' (PrEliMS), explored how best to provide support. People with MS completed a self-help workbook, alongside receiving support from MS nurses. The workbook is based on a psychological therapy called Acceptance and Commitment Therapy and was developed through focus groups of people with MS, relevant stakeholders, and clinical expertise. In this study, issues were found with parts of the workbook content and delivery. Nurses found it difficult to facilitate this alongside their usual MS Nurse care and felt psychological distress was not within their remit.
In this study, the investigators will
Read more
- explore how effective the PrEliMS workbook is at reducing distress from MS diagnosis, when delivered by a Psychology Practitioner (Trainee Clinical Psychologist)
- compare delivery by a Psychology Practitioner with the data from the Nurse delivered PrEliMS trial to explore which is more effective
- explore experience of the PrEliMS-2 intervention and potential improvements.
The investigators will recruit between three and seven people from an MS clinic who have received an MS diagnosis in the last year and consent to taking part. Participants will meet with a Psychology Practitioner (over the phone or online) once a week for four weeks, alongside completing the workbook. The investigators will also ask participants to complete questionnaires to examine their levels of psychological distress. Interviews will then be conducted to get feedback for refining the workbook.
The overall study will last a year
- Conditions
- Multiple Sclerosis
- Being tested
- Acceptance and Commitment Therapy
- Keywords
- Acceptance and Commitment Therapy
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment TherapyOther
Participants will then commence the intervention for the next 4 weeks. They will be sent the workbook via post. This will not be a standalone self-help intervention; participants will progress through the workbook alongside weekly emotional support sessions. These will either be over the phone or using an online video-call software, depending on participants preference. The first session will be an hour long to set-up the workbook, answer questions and go through goal setting. The following three weekly sessions will be half an hour to revisit exercises in the workbook, answer questions and review how the workbook progress is going. All sessions will be delivered by a trainee clinical psychologist who will receive standardised training and ongoing supervision from an experienced clinical psychologist.
| Study group | Role | What they receive |
|---|---|---|
| PrEliMS Intervention | Experimental | We will ask participants to complete the psychological impact of MS scale, anxiety/depression questionnaires and visual analogue scales once a week throughout their involvement in the study (estimated to be 9 weeks). The baseline will be established over a period of the first three weeks (before participants start the intervention). Participants will also be asked to complete a second set of questionnaires (secondary measures) before starting the intervention, to assess quality of life, stress, the impact of MS, MS-related self-efficacy and fatigue.
Participants will then be invited to an optional semi-structured, feedback interview to provide qualitative information on their experience of the intervention. Receives: Other: Acceptance and Commitment Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived psychological impact of MS
The principle primary outcome (main primary outcome of interest). Multiple Sclerosis Impact Scale-Psychological Subscale (MSIS-29-PSYCH; Hobart et al., 2001; Ramp et al., 2009). Total scores range from 0-45, with higher scores indicating greater perceived psychological impact of MS. Nine scaled questions with scale values ranging from 1-5.
Measured: Once a week from baseline to 1-week follow-up, and 1-month follow-up
Patient Health Questionnaire - 9 (PHQ-9)
Change in the level of depression symptoms. Higher scores indicate a worse outcome, total scores range from 0-27, scale values range from 0-3.
Measured: Once a week from baseline to 1-week follow-up, and 1-month follow-up
Generalised Anxiety Disorder - 7 (GAD-7)
Change in the level of anxiety symptoms. Higher scores indicate a worse outcome, total scores range from 0-21, scale values range from 0-3.
Measured: Once a week from baseline to 1-week follow-up, and 1-month follow-up
Visual Analogue Scales
Change in (1) the level of psychological distress related to receiving an MS diagnosis, (2) confidence in managing the physical impact day to day and (3) confidence in managing the psychological impact day to day. Scale ranges from 0-10.
Measured: Once a week from baseline to 1-week follow-up, and 1-month follow-up
Secondary outcomes (4)
Health-related quality of life
EQ-5D-5L (Herdman et al., 2011). Five scaled questions assessing five domains of quality of life (mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each response corresponds to a 1-digit number. The total responses are combined into a 5-digit number to represent health state, e.g., 11111 represents no problems in health state. These are then converted to an index score; higher scores indicate greater health related quality of life.
Measured: Baseline, 1-week follow-up and 1-month follow-up
Perceived levels of stress
Perceived Stress Scale 4 (PSS4; Cohen et al., 1983). Total scores range from 0-40, with higher scores indicating greater perceived level of stress. Ten scale questions, scaled values range from 0-4.
Measured: Baseline, 1-week follow-up and 1-month follow-up
Self efficacy in the context of MS
Multiple Sclerosis Self Efficacy Scale (MSSES; Rigby et al., 2003). Total score ranges from 0-84, with higher scores indicating greater level of self-efficacy. 14 scaled questions with values ranging from 1-6.
Measured: Baseline, 1-week follow-up and 1-month follow-up
Levels of fatigue
Modified Impact Fatigue Scale; abbreviated version (MFIS-5; Fisk et al., 1994; Fischer et al., 1999). Total score ranges from 0-20; higher scores indicate greater impact of fatigue. Scale scores range from 0-4 with 5 scaled questions.
Measured: Baseline, 1-week follow-up and 1-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start12 Aug 2022
- Primary completion28 Apr 2023
- Study completion30 Jun 2023
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 University of NottinghamThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- Case series design
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nima Moghaddam, DClinPsy, Study chair, University of LincolnNikos Evangelou, DPhil, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05225012
- Sponsor's protocol ID
- 21082
- Acronym
- PrEliMS2
- Status last verified
- Nov 2024
- First submitted
- 10 Jan 2022
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Providing Emotional Support Around the Point of Multiple Sclerosis Diagnosis: PrEliMS 2
- ClinicalTrials.gov ID
- NCT05225012
- Acronym / sponsor ID
- PrEliMS2 / 21082
- Conditions
- Multiple Sclerosis
- Keywords
- Acceptance and Commitment Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 12 Aug 2022 (actual)
- Primary completion
- 28 Apr 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 4 Feb 2022 (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.
Emotional support following Multiple Sclerosis (MS) diagnosis is not part of the current service provision. However, research has identified a need for this as poor adjustment to diagnosis has been linked to higher levels of psychological distress. A previous study, named 'Providing Emotional Support Around the Point of MS Diagnosis' (PrEliMS), explored how best to provide support. People with MS completed a self-help workbook, alongside receiving support from MS nurses. The workbook is based on a psychological therapy called Acceptance and Commitment Therapy and was developed through focus groups of people with MS, relevant stakeholders, and clinical expertise. In this study, issues were found with parts of the workbook content and delivery. Nurses found it difficult to facilitate this alongside their usual MS Nurse care and felt psychological distress was not within their remit.
In this study, the investigators will
- explore how effective the PrEliMS workbook is at reducing distress from MS diagnosis, when delivered by a Psychology Practitioner (Trainee Clinical Psychologist)
- compare delivery by a Psychology Practitioner with the data from the Nurse delivered PrEliMS trial to explore which is more effective
- explore experience of the PrEliMS-2 intervention and potential improvements.
The investigators will recruit between three and seven people from an MS clinic who have received an MS diagnosis in the last year and consent to taking part. Participants will meet with a Psychology Practitioner (over the phone or online) once a week for four weeks, alongside completing the workbook. The investigators will also ask participants to complete questionnaires to examine their levels of psychological distress. Interviews will then be conducted to get feedback for refining the workbook.
The overall study will last a year
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Case series design
| Arm | Type | Receives |
|---|---|---|
| PrEliMS Intervention | Experimental | Other: Acceptance and Commitment TherapyWe will ask participants to complete the psychological impact of MS scale, anxiety/depression questionnaires and visual analogue scales once a week throughout their involvement in the study (estimated to be 9 weeks). The baseline will be established over a period of the first three weeks (before participants start the intervention). Participants will also be asked to complete a second set of questionnaires (secondary measures) before starting the intervention, to assess quality of life, stress, the impact of MS, MS-related self-efficacy and fatigue. Participants will then be invited to an optional semi-structured, feedback interview to provide qualitative information on their experience of the intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18 and/or over.
- Received a new diagnosis of MS within the last twelve months, confirmed by a Consultant Neurologist.
- Scores ≥18 on the MSIS-Psy.
Key exclusion criteria (5 listed)
- Unable or willing to give informed consent.
- Individuals currently receiving psychological therapy, to ensure any change cannot be attributed to another intervention.
- Individuals who have had a prior diagnosis of psychological distress, e.g., Depression or Anxiety Disorder, to ensure participants are as homogenous as possible. The intervention is aimed at distress specifically related to receiving an MS diagnosis.
- Unable to speak and read English (as all measure used have been standardised and validated in English, and the workbook is only available in English).
- Unable to use/do not have access to a telephone or a computer with internet connection
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 |
|---|---|---|
| Acceptance and Commitment TherapyParticipants will then commence the intervention for the next 4 weeks. They will be sent the workbook via post. This will not be a standalone self-help intervention; participants will progress through the workbook alongside weekly emotional support sessions. These will either be over the phone or using an online video-call software, depending on participants preference. The first session will be an hour long to set-up the workbook, answer questions and go through goal setting. The following three weekly sessions will be half an hour to revisit exercises in the workbook, answer questions and review how the workbook progress is going. All sessions will be delivered by a trainee clinical psychologist who will receive standardised training and ongoing supervision from an experienced clinical psychologist. | Other | PrEliMS Intervention |
Primary outcome
Perceived psychological impact of MS
Time frame: Once a week from baseline to 1-week follow-up, and 1-month follow-up
The principle primary outcome (main primary outcome of interest). Multiple Sclerosis Impact Scale-Psychological Subscale (MSIS-29-PSYCH; Hobart et al., 2001; Ramp et al., 2009). Total scores range from 0-45, with higher scores indicating greater perceived psychological impact of MS. Nine scaled questions with scale values ranging from 1-5.
Patient Health Questionnaire - 9 (PHQ-9)
Time frame: Once a week from baseline to 1-week follow-up, and 1-month follow-up
Change in the level of depression symptoms. Higher scores indicate a worse outcome, total scores range from 0-27, scale values range from 0-3.
Generalised Anxiety Disorder - 7 (GAD-7)
Time frame: Once a week from baseline to 1-week follow-up, and 1-month follow-up
Change in the level of anxiety symptoms. Higher scores indicate a worse outcome, total scores range from 0-21, scale values range from 0-3.
Visual Analogue Scales
Time frame: Once a week from baseline to 1-week follow-up, and 1-month follow-up
Change in (1) the level of psychological distress related to receiving an MS diagnosis, (2) confidence in managing the physical impact day to day and (3) confidence in managing the psychological impact day to day. Scale ranges from 0-10.
4 secondary outcomes
Health-related quality of life
Time frame: Baseline, 1-week follow-up and 1-month follow-up
Perceived levels of stress
Time frame: Baseline, 1-week follow-up and 1-month follow-up
Self efficacy in the context of MS
Time frame: Baseline, 1-week follow-up and 1-month follow-up
Levels of fatigue
Time frame: Baseline, 1-week follow-up and 1-month follow-up
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 15 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Nima Moghaddam, DClinPsy study chair
University of Lincoln
Nikos Evangelou, DPhil principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy in people with Multiple Sclerosis, run by University of Nottingham at 1 site in United Kingdom.
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 3 inclusion and 5 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 15 Nov 2024. 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 Kingdom. 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?
Perceived psychological impact of MS (time frame: Once a week from baseline to 1-week follow-up, and 1-month follow-up). The study lists 4 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 15 Nov 2024.