Clinical trial NCT05225012: Providing Emotional Support Around the Point of Multiple Sclerosis Diagnosis: PrEliMS 2
Official title: Providing Emotional Support Around the Point of Multiple Sclerosis Diagnosis: PrEliMS 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Acceptance and Commitment Therapy
Lead sponsor: University of Nottingham
Sponsor class: OTHER
First posted: 2022-02-04
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Case series design
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Perceived psychological impact of MS
timeFrame: Once a week from baseline to 1-week follow-up, and 1-month follow-up
measure: Patient Health Questionnaire - 9 (PHQ-9)
timeFrame: Once a week from baseline to 1-week follow-up, and 1-month follow-up
measure: Generalised Anxiety Disorder - 7 (GAD-7)
timeFrame: Once a week from baseline to 1-week follow-up, and 1-month follow-up
measure: Visual Analogue Scales
timeFrame: Once a week from baseline to 1-week follow-up, and 1-month follow-up
Secondary outcomes:
measure: Health-related quality of life
timeFrame: Baseline, 1-week follow-up and 1-month follow-up
measure: Perceived levels of stress
timeFrame: Baseline, 1-week follow-up and 1-month follow-up
measure: Self efficacy in the context of MS
timeFrame: Baseline, 1-week follow-up and 1-month follow-up
measure: Levels of fatigue
timeFrame: Baseline, 1-week follow-up and 1-month follow-up
Other outcomes:
measure: Comprehensive Assessment of Acceptance and Commitment Therapy processes (CompACT-8; Morris, 2019; Dawson & Golijani-Moghaddam, 2020).
timeFrame: Once a week from baseline to 1-week follow-up, and 1-month follow-up
Locations:
city: Nottingham
country: United Kingdom
facility: Queens Medical Hospital
Study officials:
affiliation: University of Lincoln
name: Nima Moghaddam, DClinPsy
role: STUDY_CHAIR
affiliation: University of Nottingham
name: Nikos Evangelou, DPhil
role: PRINCIPAL_INVESTIGATOR
References: