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The Impact of Positive Mental Training in Multiple Sclerosis (PosMTMS)

Primary Purpose

Multiple Sclerosis, Psychological Distress

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Positive Mental Training
treatment as usual
Sponsored by
University of Edinburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Have confirmed diagnosis of Multiple Sclerosis

Exclusion Criteria:

  • 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)

Sites / Locations

  • Anne Rowling Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Hospital Anxiety and Depression Scale (HADS)
Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS)

Secondary Outcome Measures

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

Full Information

First Posted
August 10, 2015
Last Updated
April 3, 2018
Sponsor
University of Edinburgh
Collaborators
NHS Lothian
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1. Study Identification

Unique Protocol Identification Number
NCT02524093
Brief Title
The Impact of Positive Mental Training in Multiple Sclerosis
Acronym
PosMTMS
Official Title
The Efficacy of Positive Mental Training in Patients With Multiple Sclerosis Experiencing Psychological Distress: A Pilot Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Edinburgh
Collaborators
NHS Lothian

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Psychiatric disturbance is common in multiple sclerosis (MS), with anxiety and depression the most frequent diagnoses. The lifetime rate of major depression is up to 50%. However, even symptoms of mood and anxiety which are not severe enough to warrant a diagnosis of a psychiatric disorder can still have a big impact people's lives. The investigators want to find ways to make people with MS feel better and cope better in their day to day life, and to be stronger inside themselves so that they don't become worried or stressed so much in the future. 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 randomised controlled trial. Patients with MS who score higher than 4 on either the Hospital Anxiety (HADS-A) or Depression Scale (HADS-D) will be admitted to the trial. They will be randomly allocated to either an intervention or control group. The intervention group will be given the treatment immediately, the other 12 weeks later. In addition to the HADS, patients will be asked to complete two further questionnaires asking about how low mood and anxiety affecting them, both when they enter the trial and 12 weeks later. These are the Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS) and EuroQol health related quality of life - 5 dimensions - 5 levels (EuroQol-5D-5L). The primary function of this pilot trial is to ascertain suitability and acceptability of this treatment for people with MS, and to guide planning of a subsequent full trial. Feedback will therefore be obtained from participants in the treatment group of their experience of using the intervention. Though the sample size of this pilot trial is small, by comparing the change in scores on rating scales in patients given the treatment to those who have not been given it yet (the control group), it may be feasible to ascertain if PosMT is a useful treatment in MS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Psychological Distress

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Positive Mental Training
Intervention Description
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 Type
Other
Intervention Name(s)
treatment as usual
Primary Outcome Measure Information:
Title
Hospital Anxiety and Depression Scale (HADS)
Time Frame
Change from baseline after 12 weeks
Title
Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS)
Time Frame
Change from baseline after 12 weeks
Secondary Outcome Measure Information:
Title
Assessment of health-related quality of life - EuroQol health related quality of life - 5 dimensions - 5 levels (EuroQol-5D-5L)
Time Frame
Change from baseline after 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have confirmed diagnosis of Multiple Sclerosis Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katy Murray, MD
Organizational Affiliation
NHS Lothian
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anne Rowling Clinic
City
Edinburgh
State/Province
Scotland
ZIP/Postal Code
EH16 4SD
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

The Impact of Positive Mental Training in Multiple Sclerosis

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