Acceptance Based Telephone Support when Transitioning to SPMS
Research type
Research Study
Full title
Acceptance Based Telephone Support around the time of Transition to Secondary Progressive Multiple Sclerosis: A Feasibility Randomised Controlled Trial
IRAS ID
257248
Contact name
Roshan das Nair
Contact email
Sponsor organisation
University of Nottingham
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Multiple Sclerosis (MS) is the most common neurological condition affecting young adults. Recent literature strongly supports the notion that those transitioning to Secondary Progressive MS (SPMS) are feeling an increasing sense of loss, frustration and worry during and following diagnosis, particularly around loss of previous activity and social relationships.
The primary objective is to assess the acceptability and credibility of an acceptance-based telephone support intervention provided during the transition to SPMS through a feasibility RCT aimed at increasing physical activity and improving social relationships.
This feasibility study will enable us to plan for a definitive trial to evaluate the effectiveness of this transition focused intervention. The aim is to evaluate the suitability of the trial procedures and intervention, and enable us to calculate the number of people needed for a definitive study. Potential participants will be those who have been recently diagnosed with SPMS, and who are aged 18 years or over, recruited through MS clinics.
Participants, after consent, will complete baseline measures before being allocated to one of two groups by chance (randomisation). Group 1 (20 patients) will receive the ‘Acceptance Based Support’ intervention which will include one face-to-face session, followed by up to five telephone sessions delivered by a Trainee Clinical Psychologist. Group 2 (20 patients) will receive one 'Orientation to the study' face-to-face session. Both groups will receive usual care. The same assessments will be repeated at 8 weeks and 12 weeks post randomisation by all participants. Feedback interviews with 12 participants will be conducted to assess what parts of the intervention were helpful or unhelpful, the acceptability of randomisation and trial procedures, and the appropriateness of the measures used. Participants will be in the study for approximately 3 months and the study is planned to last for 12 months (April 2019-April 2020).
REC name
North West - Preston Research Ethics Committee
REC reference
19/NW/0261
Date of REC Opinion
10 Jun 2019
REC opinion
Further Information Favourable Opinion