The Impact of Positive Mental Training in Multiple Sclerosis

NCT02524093 | Completed

• 1 other identifier: PosMT1.0
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Depression and anxiety are common in MS and often go untreated. Even symptoms which do not meet the threshold for a psychiatric diagnosis can have a significant impact on quality of life. Positive Mental Training (PosMT) is a 12 week programme which aims to help people overcome the negative thinking and feelings that come with worry and low mood and become more positive, confident and resilient. To find out if Positive Mental Training is helpful in MS the investigators are running a randomised controlled trial. The initial study is a pilot tiral, the primary function being examination of the feasibility and acceptability of this treatment in MS. Though sample size is small and consequently it may not be powered to detect a significant change in symptoms in association with the treatment, this will also be examined.

Conditions

Multiple Sclerosis; Psychological Distress

Outcome Measures

Primary Outcomes (2)

• Hospital Anxiety and Depression Scale (HADS)

  Change from baseline after 12 weeks

• Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS)

  Change from baseline after 12 weeks

Secondary Outcomes (1)

• Assessment of health-related quality of life - EuroQol health related quality of life - 5 dimensions - 5 levels (EuroQol-5D-5L)

  Change from baseline after 12 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Participants in this arm will be given the Positive Mental Training programme. This consists of twelve eighteen minute audio tracks. Each is listened to in turn every day, once a day for a week (or at least 5 days in a week). This means that to use the treatment properly the participant needs to spend 18 minutes a day for 12 weeks listening to it. Each track guides the listener through different instructions which aim to build skills and bring about positive change. The programme begins with simple relaxation, going on to support the creation of pictures in your head of safe places and a more positive future.

Behavioral: Positive Mental Training

Control

PLACEBO COMPARATOR

Will receive treatment as usual for 12 weeks, when will be asked to complete rating scales again. They will then be given the Positive Mental Training programme.

Other: treatment as usual

Interventions

Positive Mental Training BEHAVIORAL

Positive Mental Training consists of twelve eighteen minute audio tracks. Each is listened to in turn every day, once a day for a week (or at least 5 days in a week). This means that to use the treatment properly you need to spend 18 minutes a day for 12 weeks listening to it. Each track guides the listener through different instructions which aim to build skills and bring about positive change. The programme begins with simple relaxation, going on to support the creation of pictures in your head of safe places and a more positive future.

Intervention

treatment as usual OTHER

Control

Eligibility Criteria

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

You may qualify if:

• Have confirmed diagnosis of Multiple Sclerosis

You may not qualify if:

• Lack capacity to provide informed consent
• Judged by the treating clinician to have cognitive deficits of such severity to preclude engagement with the treatment
• Felt by the treating clinician to be unsuitable to participate on other clinical grounds (e.g. significant receptive aphasia) will be excluded.
• Do not speak English (they would be unable to independently make use of the intervention)

Sponsors & Collaborators

• University of Edinburgh: lead
• NHS Lothian: collaborator

Study Sites (1)

Anne Rowling Clinic

Edinburgh, Scotland, EH16 4SD, United Kingdom

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

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

Study Officials

• Katy Murray, MD

  NHS Lothian

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Neuologist

Study Record Dates

• First Submitted: August 10, 2015
• First Posted: August 14, 2015
• Study Start: January 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: April 5, 2018

Record last verified: 2018-04

Locations

GB (1)