An interventional study of Acceptance and Commitment Therapy in Multiple Sclerosis, sponsored by University of Nottingham. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-15.
Sponsored by University of Nottingham · Not applicable, Interventional, and Treatment
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
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
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 5 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →University of Nottingham is the lead sponsor of 455 studies on the registry; 77 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Once a week from baseline to 1-week follow-up, and 1-month follow-up
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.
Time frame: Baseline, 1-week follow-up and 1-month follow-up
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.
Time frame: Baseline, 1-week follow-up and 1-month follow-up
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.
Time frame: Baseline, 1-week follow-up and 1-month follow-up
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.
Time frame: Baseline, 1-week follow-up and 1-month follow-up
Comprehensive Assessment of Acceptance and Commitment Therapy processes (CompACT-8; Morris, 2019; Dawson & Golijani-Moghaddam, 2020).
Process measure. 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.
Time frame: Once a week from baseline to 1-week follow-up, and 1-month follow-up
Plan to share: No
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University of Nottingham