Providing Emotional Support Around the Point of Multiple Sclerosis Diagnosis: PrEliMS 2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Perceived psychological impact of MS
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Perceived psychological impact of MS
时间窗: 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)
时间窗: 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)
时间窗: 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
时间窗: 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.
次要结局
- Health-related quality of life(Baseline, 1-week follow-up and 1-month follow-up)
- Perceived levels of stress(Baseline, 1-week follow-up and 1-month follow-up)
- Self efficacy in the context of MS(Baseline, 1-week follow-up and 1-month follow-up)
- Levels of fatigue(Baseline, 1-week follow-up and 1-month follow-up)