Providing Emotional Support Around the Point of Multiple Sclerosis Diagnosis: PrEliMS 2

CompletedNot a drug-phase studyMS (type not specified)NCT05225012

We could not find results for this trial

What it found

No results found

We found no results in the registry or in papers.

This trial finished 3 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Acceptance and Commitment Therapy

What it measured

Main measures

  • Perceived psychological impact of MS

    Once a week from baseline to 1-week follow-up, and 1-month follow-up

    Quality of life (reported by participants)
  • Patient Health Questionnaire - 9 (PHQ-9)

    Once a week from baseline to 1-week follow-up, and 1-month follow-up

    Mood and sleep
  • Generalised Anxiety Disorder - 7 (GAD-7)

    Once a week from baseline to 1-week follow-up, and 1-month follow-up

    Mood and sleep
  • Visual Analogue Scales

    Once a week from baseline to 1-week follow-up, and 1-month follow-up

Other measures (4)

  • Health-related quality of life

    Baseline, 1-week follow-up and 1-month follow-up

    Walking and mobilityPainMood and sleepQuality of life (reported by participants)
  • 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

    Fatigue

Who could take part

MS (type not specified) · 18 and over

Show the full criteria

Inclusion criteria

1. Aged 18 and/or over. 2. Received a new diagnosis of MS within the last twelve months, confirmed by a Consultant Neurologist. 3. Scores ≥18 on the MSIS-Psy.

Exclusion criteria

1. Unable or willing to give informed consent. 2. Individuals currently receiving psychological therapy, to ensure any change cannot be attributed to another intervention. 3. 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. 4. 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). 5. Unable to use/do not have access to a telephone or a computer with internet connection

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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

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History

    1. Started

      Aug 2022

    2. Main results due

      Apr 2023

    3. Finished

      Jun 2023

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