An Exploration of Simulated Presence Therapy as a Formulation Based Intervention for Dementia Related Distress.

Background: Persons with dementia (PwD) often present with a cluster of signs or symptoms of distorted perceptions, thoughts, mood and behaviours, commonly referred to as the behavioural and psychological symptoms of dementia. Psychosocial conceptualisations posit that these symptoms manifest as a result of distress arising from an unmet need; thus, the term 'stressed and distressed behaviours' (SDB) may more accurately represent the aetiology of these symptoms. This ethos has been aggregated into the Newcastle model, first conceptualised by Dr Ian James and his colleagues, which emphasises a formulation-based approach to dementia care. Formulation refers to the process of collaboratively developing a hypothesis regarding an individual's difficulties by incorporating psychological theory and evidence.

Although formulation-based approaches are become more widespread, prescribing practices for medical treatments remains suboptimal across dementia care settings. Considering the personal, societal and economic burdens of SDB in PwD, coupled with the disadvantages of pharmacological interventions, there remains a real need to develop effective non-pharmacological, psychosocial alternatives. One such intervention is Simulated Presence Therapy (SPT).

SPT is an intervention that involves playing a video and/or audio recording of a loved one to a PwD with a reassuring message when they present with SDB. Studies examining the efficacy of SPT are sparse; however, what little research that has been conducted has highlighted its effectiveness in some instances. Thus far, studies have not explored SPT when it has been identified as a way of addressing an unmet need through a formulation-driven assessment process. Instead, it has been applied to participants within specific care settings with a symptom rather than formulation-based approach. Hence, this study will explore the efficacy of SPT as part of a formulation-driven approach, grounded in the Newcastle model.

Aim/objectives (s): The present study will aim to investigate the efficacy of SPT for SDB in PwD when it has been specifically identified via a Newcastle formulation as the preferred intervention within care homes and hospital wards operated by the National Health Service of Greater Glasgow and Clyde (NHSGGC) and their associated Health and Social Care Partnerships (HSCP). The research is being conducted to fulfil part of the requirements of the Principal Investigator's Doctorate in Clinical Psychology Qualification at the University of Glasgow, and the University will therefore be an additional collaborating organisation. In terms of objectives:

• Primary Objective - Introduction of SPT will significantly reduce SDB during day-to-day activities when compared to activities without SPT.
• Secondary Objective - What is the acceptability of SPT amongst healthcare professionals that administer it?

Design: This study will employ a randomised single case experimental design (SCED) of two phases (i.e. AB) with multiple baselines. This which would involve randomly allocating PwD to a staggered baseline period (A), followed by the intervention phase (B), which would last as long as the corresponding baseline phase.

Sample: Owing to the fact that, whilst the PwD are the participants that will form the key group to answer the research question, from a technical perspective, the sample consists of multiple categories of persons. For clarity, the following terms are employed:

1. 'Participants' will refer to the PwD recruited to receive SPT.
2. 'Informants' will refer to the person who complete the two attachment/relationship questionnaires for the participant.
3. 'Recorders' will refer to non-healthcare professionals, such as family members or friends, who agree to be filmed for the SPT video.
4. 'Professionals' will refer to the care staff involved in the PwD's care who complete the staff user-experience questionnaire within this study.
5. 'Sample' will refer to all persons participating in the study (i.e. Participants, Informants, Recorders and Professionals).

The anticipated minimum sample size is 13, consisting of participants (N = 6), informants/recorders (N = 6) and professional(s) (N = 1). Recruitment will be from identified care homes and hospital wards that receive input from NHSGGC's Older Person Psychology Service (OPPS).

Measure(s):

• Dementia Severity Rating Scale (DSRS) - This is a validated multiple-choice, informant-based questionnaire, designed to categorise the severity of a patient's dementia. These categories are 'mild', 'moderate' or 'severe'.
• Measure of Attachment Adapted (MOA) - This is a measure of attachment that has been adapted by the Principal Investigator for use in the present study and to be answered by informants. Informants are asked to read three paragraphs and asked to tick which one they feel best describes the patient. There are two sections of the measure: (1) One for if the informant has known the patient before they received their diagnosis of dementia, and (2) another for if the informant knew the patient ONLY after they received a diagnosis. The informant needs to only complete one of these sections. Attachment style can then be categorised as 'secure', 'avoidant' or 'anxious/ambivalent'.
• Measure of Attachment Qualities Adapted (MAQ) - This is a multiple-choice, Likert-scale measure of attachment that has been adapted by the Principal Investigator for use in the present study and to be answered by informants. There are two sections of the measure: (1) One for if the informant has known the patient before they received their diagnosis of dementia, and (2) another for if the informant knew the patient ONLY after they received a diagnosis. The informant needs to only complete one of these sections. Attachment style can then be categorised as 'secure', 'avoidant', 'ambivalent-worry' or 'ambivalent-merger'.
• Unified Theory of Acceptance and Use of Technology (UTAT)-informed Questionnaire - This is a self-report, Likert scale questionnaire developed by the Principal Investigator based on the UTAT. The measure consists of a series of statements pertaining to the usefulness and effectiveness of SPT with respondents who administered SPT selecting how strongly they agree/disagree with each. Higher scores are indicative of greater usefulness, acceptability and/or effectiveness.
• Frequency Chart - This is a chart which is used to tally the number of dSDB exhibited by patients within a specific time period and day. These recordings are made by healthcare staff who work directly with a patient.

Procedures: The process for recruitment is as follows: where capacity to consent is retained, this will be sought from the participant; where the participant is deemed to not have capacity to consent, informed consent for will be obtained from the relevant legal guardian/next of kin; informed consent for those persons who are not healthcare professionals, but complete questionnaires and record videos for the participants, will also be obtained with regard to inclusion of their responses within the present study. Informed consent for the staff UTAT-informed questionnaire will also be obtained.

Following the recruitment process, arrangements to obtain recordings and complete the MOA and MAQ will be established collaboratively between the person recorded and NHSGGC OPPS. All participants will have already received a Newcastle formulation as part of routine care and will be randomly allocated to randomly allocated to a 14, 17 or 21-day baseline period where dSDB is tallied. Immediately once the baseline phase has concluded, the intervention phase will commence, which will last indefinitely for the participants for whom SPT is an effective intervention, although the data that will be extracted at intervention stage will be at least the length of the baseline.

The UTAT-informed questionnaire would be disseminated to professionals near the conclusion of the data collection stage.

Data Analysis: Data analysis for evaluating intervention effects in SCEDs encompasses visual inspection and statistical analysis. Visual analysis involves examining level, trend, variability, immediacy of effect, overlap, and consistency of data patterns within and between phases. Statistical analysis will involve calculation of a Baseline Corrected Tau (BC-Tau) to measure data non-overlap between the two phases (A and B). Non-overlapping data as an indicator of performance difference between phases is included in standards for evaluating SCEDs. Additionally, BC-Tau is useful in aggregating data across phases to produce an overall effect size.

Evaluation of the secondary objective will involve calculating the average score across participants on the UTAT informed questionnaire, with a higher score indicative of greater acceptability.

Ethics and safety: A number of safeguards are in place regarding sample and researcher safety with relevant policies and legislation consulted in the construction of this project. These are detailed in full within the uploaded research protocol. Applications/approvals will be sought by an Ethics committee and NHSGGC's Research and Innovation department. Approval to proceed to ethics for this project has been obtained from the University of Glasgow.

Timetable:

• May/June 2021: Ethics submission.
• June/July 2021 - December 2021: Recruitment and data collection.
• January 2022: End of data collection, data analysis and write-up.
• February-April 2022: Final report article generated.

Dissemination/application: The results of this study will provide insight into the efficacy of SPT when used as part of a formulation-driven approach to dementia care. It is anticipated that this information will enable service providers to understand how to integrate SPT in services and care pathways for PwD. Dissemination will occur once the final research article has been generated by the Principal Investigator, which will be made available on the University of Glasgow's Enlighten thesis repository for public domain access in PDF format, and possibly in a paper that will be submitted for publication.