Providing Emotional Support Around the Point of Multiple Sclerosis Diagnosis: PrEliMS 2
- Conditions
- Multiple Sclerosis
- Interventions
- Other: Acceptance and Commitment Therapy
- Registration Number
- NCT05225012
- Lead Sponsor
- University of Nottingham
- Brief 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. 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description PrEliMS Intervention Acceptance and Commitment Therapy We will ask participants to complete the anxiety/depression questionnaires and visual analogue scales once a week throughout the participants 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. The procedure will then repeated with newly recruited participants, and the newly refined workbook will be used. Participants within this phase will also be invited to feedback interviews a week after completion of the intervention.
- Primary Outcome Measures
Name Time Method Perceived psychological impact of MS 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) 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) 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 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.
- Secondary Outcome Measures
Name Time Method Health-related quality of life Baseline, 1-week follow-up and 1-month follow-up 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.
Perceived levels of stress Baseline, 1-week follow-up and 1-month follow-up 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.
Self efficacy in the context of MS Baseline, 1-week follow-up and 1-month follow-up 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.
Levels of fatigue Baseline, 1-week follow-up and 1-month follow-up 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.
Trial Locations
- Locations (1)
Queens Medical Hospital
🇬🇧Nottingham, United Kingdom