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

NCT ID: NCT05225012

Last Updated: 2024-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-12
• Study Completion Date: 2023-06-30

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

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PrEliMS Intervention

We will ask participants to complete the psychological impact of MS scale, anxiety/depression questionnaires and visual analogue scales once a week throughout their 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.

Participants will then be invited to an optional semi-structured, feedback interview to provide qualitative information on their experience of the intervention.

Group Type: EXPERIMENTAL

Acceptance and Commitment Therapy

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Nottingham

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nima Moghaddam, DClinPsy

Role: STUDY_CHAIR

University of Lincoln

Nikos Evangelou, DPhil

Role: PRINCIPAL_INVESTIGATOR

University of Nottingham

Locations

Queens Medical Hospital

Nottingham, , United Kingdom

Countries

United Kingdom

Other Identifiers

21082

Identifier Type: -

Identifier Source: org_study_id