Positive Mental Training Tool (PosMT) for stroke - Primary Care Unit

Title:	Positive Mental Training Tool (PosMT) for stroke
Principal research question:	The aims of this study are to make a preliminary assessment through patient and carer feedback of the potential use of an audiobased Positive Mental Training Programme (PosMT) in the management of patients with poststroke depression or distress. The programme has previously been shown to be a costeffective tool for improving depression in patients in primary care. The results of this prepilot study would then enable the design of a subsequent pilot trial and then a multicentre randomised controlled trial (RCT) of the intervention to assess its efficacy and costeffectiveness in patients with poststroke depression or distress in the community. The main research question: Is the PosMT tool a feasible and acceptable tool for use in patients poststroke?
Background:	This research is looking at a new way of helping people with stroke deal with low mood, depression and anxiety. It involves use of a guided selfhelp programme, the ‘Positive Mental Training’ audio, which helps improve negative mood and increases positive outlook. The programme uses relaxation, mindfulness and positive psychology to generate positive feelings, allowing people to overcome negative thinking patterns and become more confident and resilient in the face of life challenges. The programme requires listening to an audio recording on a CD or over the internet for 18 minutes a day for 12 weeks with a different recording to listen to each week (although results may be seen after 4 weeks). Optimism, a positive outlook and being able to relax and handle stress may increase peoples’ ability to cope with the effects of having a stroke and to be more actively involved in their rehabilitation. It may also help speed up rehabilitation through biological pathways which help the body to recover when free of stress. The aim of this research is to see whether the programme is acceptable and holds promise for use in people with stroke who are low in mood or positive outlook. People with stroke and their carers who have previously shown an interest through patient and carer groups will be asked to review the content of the audio programme in this prepilot study. Participants do not have to be depressed or anxious. Participants will be asked to listen to the first 4 weeks of the audio programme. Measures will consist of questionnaires at baseline and at followup. Qualitative interviews will be undertaken at followup. The results from this prepilot will inform a pilot for a future RCT where the tool will be tested against standard care, for which funding will be sought.
Methodology description:	Patients and carers will be drawn from existing focus groups of patients and carers (Kings College London Stroke Research Patient and Family Group, and the local Stroke Association Voluntary Support Group Peterborough) who have already shown an interest to volunteer to listen to the Positive Mental Training (PosMT) tool to assess its preliminary suitability for use with patients after stroke who may have depression or distress. These volunteers themselves need not be depressed or anxious in order to assist with this stage of the assessment of the tool. 10-15 patients will be asked to volunteer (plus or minus their carers). Participants who are over 18 will be able to volunteer to listen to the audios. Those who lack capacity to provide informed consent, have moderate to severe cognitive deficits or who are felt by their GP to be unsuitable on clinical grounds (including patients with significant receptive aphasia or deafness) will not be asked to participate, as will patients who do not speak English as they will not be able to benefit directly. Carers of patients are given the option of taking part in assisting with the study should they so wish. They may either choose to listen to the programme alongside the patient or take part in followup interview and assessment only. However, if they decide not to take part, this does not prevent the patient for whom they care for in taking part. Patients and carers who have agreed to take part in the study will be given a number of initial screens with questionnaires to exclude severe depression and suicidality, to assess acceptability and completion time for scales, and in order to assess which type of patients may find the tool most useful. Scales to be administered to patients and participating carers will include the Positive and Negative Affective Scale (PANAS), Hospital Anxiety and Depression Scale (HADS) (or Depression Intensity Scales Circles (DISCs)) in case of dysphasia, assessment of function and quality of life (SF36) and for carers, the Carer Strain Index (CSI). The BASDEC suicide question will also be asked to detect any suicidality. Patients or carers who are severely depressed (HADS–D>15 or DISCs>4 or who respond ‘true’ to the single BASDEC suicide question), will be referred to their GP and excluded from the study. GPs of all patients and carers who would like to participate will be approached and asked to respond with a reply slip prior to using the tool to confirm capacity and to ensure that there is no reason why they should not participate. The tool consists of 12 audio tracks each lasting 18 minutes, to be listened to everyday for a week with a different track each week. Patients will be supplied with the tool either as a downloadable mp3 or a CD. The full programme consists of 12 weeks of daily listening to an audio. However, most benefit may be obtained within the first 4 weeks of listening and since this is a prepilot to gather patients and carers views of the tool and not a full trial, listening to the whole programme will not be required. However, patients and carers may choose to continue to listen to the remainder of the audios should they wish to do so prior to interview at 46 weeks. A few participants will be asked to listen to the remaining 8 audio files just to identify any potential issues (mostly technical / content) that may arise. Participants will receive weekly followup phone calls for the 4 weeks of the study to ensure that they are experiencing no problems with listening to the audios. Patients and their carers who are participating will be interviewed around 4 to 6 weeks after starting the programme. The interviews will explore patient and carer views with regard to: likely benefits of the PosMT programme; whether it may be particularly useful in specific groups; whether it is easy to use; if patients would adhere to it; if they see any harmful consequences to its use; and how it might be adapted to best suit patients with stroke. Interviews will last about 30 minutes and will be recorded and responses transcribed and analysed. At the followup visit, the screening questionnaires will also be repeated in both patients and carers as a form of preliminary assessment of effectiveness and potential for use of the scales in a further pilot trial. Part of the study will be to assess the time taken to complete these tools, but an estimated time is around 30 minutes.
Project organisation
Start date:	1st November 2013
End date:	31st December 2014
Contact person:	Dr Kate Williams
Contact Details:	Strangeways Research Laboratory Worts Causeway Cambridge Cambs CB1 8RN UK Telephone: (01223) 330332 E-mail: kmw36@medschl.cam.ac.uk
References and Publications