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

NCT05225012 | Completed

• 1 other identifier: 21082
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Keywords

Acceptance and Commitment Therapy

Outcome Measures

Primary Outcomes (4)

• Perceived psychological impact of MS

  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.

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

• 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, and 1-month follow-up

• 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, and 1-month follow-up

• Visual Analogue Scales

  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.

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

Secondary Outcomes (4)

• 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

Other Outcomes (1)

• Comprehensive Assessment of Acceptance and Commitment Therapy processes (CompACT-8; Morris, 2019; Dawson & Golijani-Moghaddam, 2020).

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

Study Arms (1)

PrEliMS Intervention

EXPERIMENTAL

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.

Other: Acceptance and Commitment Therapy

Interventions

Acceptance and Commitment Therapy 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.

PrEliMS Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

Queens Medical Hospital

Nottingham, NG7 2UH, United Kingdom

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Nima Moghaddam, DClinPsy

  University of Lincoln

  STUDY CHAIR

• Nikos Evangelou, DPhil

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Case series design

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: February 4, 2022
• Study Start: August 12, 2022
• Primary Completion: April 28, 2023
• Study Completion: June 30, 2023
• Last Updated: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)