Acceptance Based Telephone Support When Transitioning to SPMS

Acceptance Based Telephone Support Around the Time of Transition to Secondary Progressive Multiple Sclerosis: A Feasibility Randomised Controlled Trial

CompletedNot a drug-phase studyProgressive MSNCT04239664

What it found

No results found

We found no results in the registry or in papers.

This trial finished 6 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Acceptance Based Telephone Support (ABS+UC)

What it measured

Main measures

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

    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.

    4 months

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

    4 months

    Feasibility

  • Success of recruitment/ recruitment rates

    4 months

    Feasibility

  • Retention rates

    4 months

    Feasibility

  • Completion rates of outcome measures

    4 months

Other measures (5)

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

    4 months

    Mood and sleep

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

    4 months

    Quality of life (reported by participants)

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

    4 months

  • EQ-5D-5L (Herdman et al., 2011)

    4 months

    Walking and mobilityPainMood and sleepQuality of life (reported by participants)

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

    4 months

Who could take part

Progressive MS · 18 and over

Show the full criteria

Inclusion criteria

1. Able and willing to consent to the trial 2. Have received a diagnosis of SPMS in the last 1 year 3. Are 18 years or over (no upper age limit) 4. Score greater than 7 (indicating clinical severity) on either subscale of the Hospital Anxiety and Depression Subscale (HADS) 5. Able to communicate in English

Exclusion criteria

1. Are currently receiving any psychological or cognitive intervention for their mental health (or received this in the last 3 months) 2. Are participating in another concurrent interventional study 3. Have a severe co-morbid psychiatric condition (e.g., dementia), as reported by patients or by the clinical team making the initial approach

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

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History

    1. Started

      Sept 2019

    2. Main results due

      Mar 2020

    3. Finished

      Mar 2020

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