Acceptance Based Telephone Support When Transitioning to SPMS

NCT04239664 | Completed

• 1 other identifier: 19019
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

What is the purpose of the study? People with Multiple Sclerosis often say that they feel less support is available after they are diagnosed with Secondary Progressive Multiple Sclerosis, compared to before they received this diagnosis. People sometimes experience a lessening of support, despite their physical symptoms becoming more severe from both professionals and those in their personal lives. The purpose of this study is to see whether providing some telephone support to those who have recently received a diagnosis of Secondary Progressive Multiple Sclerosis is experienced as helpful and is possible to do practically. This study will help the investigators understand which type of support may be helpful for patients in the future and may pave the way for larger studies and changes to NHS provision. Who is it for? Participants will be those who have transitioned recently (within the last year) to Secondary Progressive Multiple Sclerosis. The investigators are inviting 40 participants to take part. What will happen to participants if they take part? Participants will be asked by their Neurologist or MS Nurse to take part in the study and will provide written consent to be contacted, which will be stored by the research team. Their details will be passed to the study team at the University of Nottingham, who will telephone the participant within a week to tell them a bit more about the study and ensure they are suitable for the study by asking them some questions. Following this, the participant will be sent some paper or online questionnaires to complete and return. After this, the researcher will visit the participant face to face to introduce themselves and answer any questions they may have. They will also tell the participants what "group" they have been randomly put into. There are two groups. Those in the first group would be asked to commit to receiving a 30 minute support phonecall each week for five weeks in addition to any usual care, and the second group will receive their usual NHS care. The support phonecalls will draw from techniques used in a type of psychological therapy (acceptance and commitment therapy). All the phonecalls can be done whilst the participant is at home or in a quiet place of their choosing. After this, both groups will fill in some more paper questionnaires eight and twelve weeks after the start of the study. The investigators expect that participants will be involved in the study for around 4 months. After the study, participants will also have the opportunity to feedback how they experienced being a participant in the study. Their responses will help the researchers understand their experience, and help them use this to think about how to adapt similar studies in the future.

Conditions

Secondary Progressive Multiple Sclerosis

Outcome Measures

Primary Outcomes (7)

• The administrative burden of the trial for participants and for investigators, measured through feedback interviews and hours per week necessary to facilitate the trial

  The administrative burden of the trial, for both the investigators and the participants will be recorded. For the participants, this will be investigated through the feedback interviews. For the investigator, this will be a measure of how many hours it takes per week to facilitate the trial.

  4 months (length of participant journey through the study)

• The appropriateness of the overall eligibility criteria, such as the total number, and ratio, of participants being included/excluded by each criteria.

  The appropriateness of the eligibility criteria will be measured through recording the numbers of eligible participants in the service, to ensure they are not too restrictive/too inclusive when considering the sample needed and the time available. The total number, and ratio, of participants being included/excluded by each criteria will be gathered. This will be important for any future trial to estimate the time it would take to recruit using the eligibility criteria.

  4 months

• The ease and success of the randomisation protocol, measured through the amount and frequency of any errors (see description) during the randomisation process.

  The ease and success of the randomisation protocol (using Sealed Envelope, SealedEnvelope.com) will be assessed, and any errors or difficulties in useability will be recorded (e.g., being unable to access the randomisation system to randomise a participant promptly, or there being a large disparity between numbers randomised in each group) .

  4 months

• Acceptability of audio recording of sessions: number who accept, decline

  The response of participants (number who accept, decline) to being audio recorded to assess fidelity of the therapy will be measured.

  4 months

• Success of recruitment/ recruitment rates

  The number of participants identified as eligible for the study (meeting all inclusion criteria) and contacted will be recorded, along with the number who agree to take part.

  4 months

• Retention rates

  The number of participants who complete the study procedures, or drop out, and for what reasons, will be recorded.

  4 months

• Completion rates of outcome measures

  The type and amount of missing data found on each questionnaire and whether this missing information could be obtained by telephone follow-up will be determined. These data will also indicate any problems of outcome questionnaires being sent by post and the ease of answering these.

  4 months

Secondary Outcomes (5)

• Hospital Anxiety and Depression Scale (HADS) (Zigmond & Snaith, 1983)

  4 months

• Multiple Sclerosis Impact Scale-29 (MSIS-29) (Riazi, Thompson, Lamping, Hobart, & Fitzpatrick, 2001)

  4 months

• Multiple Sclerosis Self-Efficacy Scale (Rigby et al., 2003)

  4 months

• EQ-5D-5L (Herdman et al., 2011)

  4 months

• Comprehensive Assessment of Acceptance and Commitment Therapy processes (CompACT) (Francis, Dawson, & Golijani-Moghaddam, 2016)

  4 months

Study Arms (2)

Acceptance Based Telephone Support (ABS+UC)

EXPERIMENTAL

One face-to-face session to be informed of the group they have been randomised into and Acceptance Based Support, followed by five 30-minute telephone sessions of Acceptance Based Support. Usual care continues as normal.

Other: Acceptance Based Telephone Support (ABS+UC)

Usual Care (Control Group) (UC)

NO INTERVENTION

One face to face session to be informed of the group they have been randomised into and encouraged to ask any questions, and will be informed they will be contacted again in 8 weeks. Usual care continues as normal.

Interventions

Acceptance Based Telephone Support (ABS+UC) OTHER

Support based on Acceptance and Committment Therapy (Hayes, 1999)

Acceptance Based Telephone Support (ABS+UC)

Eligibility Criteria

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

You may qualify if:

• Able and willing to consent to the trial
• Have received a diagnosis of SPMS in the last 1 year
• Are 18 years or over (no upper age limit)
• Score greater than 7 (indicating clinical severity) on either subscale of the Hospital Anxiety and Depression Subscale (HADS)
• Able to communicate in English

You may not qualify if:

• Are currently receiving any psychological or cognitive intervention for their mental health (or received this in the last 3 months)
• Are participating in another concurrent interventional study
• Have a severe co-morbid psychiatric condition (e.g., dementia), as reported by patients or by the clinical team making the initial approach

Sponsors & Collaborators

• University of Nottingham: lead
• Nottingham University Hospitals NHS Trust: collaborator

Study Sites (1)

Queens Medical Centre, Nottingham

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Location

MeSH Terms

Conditions

Multiple Sclerosis, Chronic Progressive

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2019
• First Posted: January 27, 2020
• Study Start: September 9, 2019
• Primary Completion: March 20, 2020
• Study Completion: March 20, 2020
• Last Updated: September 25, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)