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

Multiple Sclerosis Clinical Trial

— PrEliMS2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05225012
• Other study ID #: 21082
• Status: Completed
• Phase: N/A
• Start date: August 12, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: September 2023
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

• revise the workbook based on feedback from participants and what was learnt from the PrEliMS feasibility trial, to improve patient experience.

The investigators will recruit seven people from an MS clinic who have received an MS diagnosis in the last 6-months 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 procedure will then be repeated with the refined workbook and seven newly recruited participants.

The overall study will last a year

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 30, 2023
• Est. primary completion date: April 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Aged 18 and/or over.

2. Received a new diagnosis of MS within the last six months, confirmed by a Consultant Neurologist.

3. Scores =8 on the GAD-7 and/or =10 on the PHQ-9.

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Acceptance and Commitment Therapy
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.

Locations

Country	Name	City	State
United Kingdom	Queens Medical Hospital	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Once a week from baseline to 1-week follow-up
Primary	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.	Once a week from baseline to 1-week follow-up
Primary	Visual Analogue Scale	Change in the level of psychological distress related to receiving an MS diagnosis and confidence in managing day to day. Scale ranges from 0-10.	Once a week from baseline to 1-week follow-up
Primary	Comprehensive Assessment of Acceptance and Commitment Therapy processes (CompACT-8; Morris, 2019; Dawson & Golijani-Moghaddam, 2020).	Scale to measure change in ACT-process of psychological flexibility. Higher scores indicate a better outcome, total scores range from 0-48, scale values range from 0-6.	Once a week from baseline to 1-week follow-up
Secondary	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.	Baseline and 1-week follow-up
Secondary	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.	Baseline and 1-week follow-up
Secondary	Perceived psychological impact of MS	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.	Baseline and 1-week follow-up
Secondary	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.	Baseline and 1-week follow-up
Secondary	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.	Baseline and 1-week follow-up