Piloting the Attention Training Technique for Post-Stroke Emotionalism
NCT Number: NCT06457126
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stroke|Emotionality|Pseudobulbar Affect|Lability Emotional|Crying
Interventions: BEHAVIORAL: Attention Training Technique
Sponsor: University of Manchester
Collaborators: Manchester University NHS Foundation Trust|Northern Care Alliance NHS Foundation Trust
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 14
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-24
Completion Date: 2025-08-30
Locations: Manchester University NHS Foundation Trust, Manchester, United Kingdom|Northern Care Alliance, Manchester, United Kingdom

Summary:
The aim of this mutli-phasic systematic case series is to explore if the Attention Training Technique (ATT) can improve symptoms of Post Stroke Emotionalism. It will teach the ATT to at least three people who have had a stroke at least six months ago, have PSE and are currently receiving support from a Community Neurorehabilitation service in the North West of England. Stroke survivors will also require the support of a carer/loved to record their symptoms on a daily basis. Stroke survivors will attend weekly appointments either at the community service site or via video-call for up to 15 weeks. There is also the option to complete an interview to discuss their experiences of learning the ATT. This study hopes to be the first step in establishing evidence in support of a novel psychological intervention to help improve PSE symptoms.

Phase 1 of the study aims to explore the effects associated with the ATT on PSE symptoms. The primary research questions are:

1a. Is the ATT associated with an improvement of PSE symptoms?

1b. Does this replicate across individual cases?

If these are not initially supported, the ATT delivery will be extended, addressing:

1. c. Is the ATT associated with an improvement of PSE symptoms when some parameters (e.g., frequency and dose) are modified?

   Only if a clear association between ATT and symptom change is demonstrated, will Phase 2 begin.

   Phase 2 aims to understand the relative mechanisms underlying any treatment effect. The primary research question for Phase 2 is:
2. a. Is the ATT associated with a greater change in PSE symptoms than a comparator passive listening intervention (controlling for non-specific factors, (e.g., provision of a credible intervention, task practice and therapist involvement))?

The comparator intervention will be a passive version of the ATT whereby participants are instructed to not follow the instructions on the audio-recording.

Secondary research questions throughout Phase 1 and 2 will address:

1. Is the active ATT (and passive ATT) associated with an improvement in executive functioning, attention, mood and quality of life and is there any difference between the two interventions?

Primary Outcome Measures: Daily Diaries - Stroke Survivor and Carer, A repeatable observational measure of PSE symptom frequency and uncontrollability. A repeatable observational measure of PSE symptom frequency and uncontrollability did not exist during the development of the study. It is typical in SCEDs for clinicians to develop measures such as these (Krasny-Pacini and Evans, 2018). A participant diary has been developed in addition to a carer diary to enable measurement of inter-rater reliability. In recognition that PSE symptoms may present on a continuum of tearfulness through to uncontrollable sobbing, a Likert scale has been developed within the measure to ascertain the severity of presenting symptoms.

This will measure:

1. Time of sudden onset tearfulness or crying
2. How tearful or how much the person cried
3. Whether the tearfulness or crying was expected or unexpected.
4. Emotions associated with start of tearfulness or crying.
5. Visual analogue scale measure of uncontrollability to controllability., Baseline: daily from time one to end of baseline. Intervention: daily from intervention time point one to end of intervention period (minimum of four to eight weeks to maximum of 15-weeks post-baseline).
Secondary Outcome Measures: The Hospital Anxiety and Depression Scale (HADS), An objective measure of anxiety and depression validated for use in stroke (Zigmond and Snaith, 1983; Sagen Vik, Finset, Moum, Vik and Dammen, 2022). It has 14-items rated on a scale from 0-3. Anxiety (7 items; maximum score 21) and Depression (7 items; maximum score 21). In response to each item, participants must select the response most appropriate to how they have felt over the past week. Higher scores indicate a worse outcome (e.g., scores between 11 and 21 indicate clinical levels of anxiety or depression)., Baseline time one; Post-intervention (a minimum of four to eight weeks to a maximum of 15-weeks from end of baseline).|The Oxford Cognitive Screen (OCS), A recommended brief cognitive assessment for stroke (Quinn, Elliott, and Langhorne, 2018). Includes ten tasks assessing executive function, attention, language, memory, number processing and praxis (Demeyere et al., 2016; Demeyere et al., 2015). The OCS will also be used as a descriptive tool for the cognitive profile of the sample.

Naming (max score 4) Semantics (3) Orientation (4) Visual Field (4) Sentence Reading (15) Number Writing (3) Calculation (4) Hearts (50) Space Asymmetry (less than -2 = right egocentric neglect. more than 3 = left neglect) Object Asymmetry (ess than -1 = right allocentric neglect. more than = left neglect) Imitation (12) Verbal Recall / Recognition (4) Episodic Recognition (4) Executive Score (-1)

Lower scores indicate greater cognitive impairment with the exception of the executive score and asymmetry tests. Higher executive score indicates greater cognitive impairment. Asymmetry scores are as above., Baseline time one; Post-intervention (a minimum of four to eight weeks to a maximum of 15-weeks from end of baseline).|World Health Organisation Quality of Life Scale (WHOQOL-BREF), A shorter, easier to administer version of the WHO-QOL and has been validated for use in stroke (Martini, Ningrum, Abdul-Mumin and Yi-Li, 2022). It is a 26-item self-report questionnaire measuring physical, psychosocial, and environmental QoL, overall QoL and health - based on the last two weeks. Raw scores are rated between 1 and 5. Maximum transformed score = 100. Higher scores indicate higher quality of life., Baseline time one; Post-intervention (a minimum of four to eight weeks to a maximum of 15-weeks from end of baseline).|Focus of Attention Rating Scale, This will be used as a manipulation check to ascertain if the ATT is working as it aims to. It includes a 7-point rating scale to measure the change from an internal to external focus of attention (Wells, 2009). Lower scores indicate an external focus of attention. Higher scores indicate an internal focus of attention., Weekly during intervention (across a minimum of four to eight weeks to a maximum of 15-weeks).|The Testing Emotionalism after Recent Stroke Questionnaire (TEARS-Q), A self-report questionnaire to identify stroke survivors experiencing sudden onset crying. It has been psychometrically validated (Broomfield et al., 2021). Maximum score = 16. Higher scores indicate higher probability of post stroke emotionalism., Screening appointment and post-intervention (ie., a minimum of four to eight weeks to a maximum of 15-weeks from end of baseline).
Other Outcome Measures: Post-Intervention Interview, An optional brief semi-structured interview exploring participants' reaction to/views on the ATT intervention (e.g., what they found helpful and/or unhelpful)., 1-week following the end of intervention (ie., a minimum of five to nine weeks to a maximum of 15-weeks post-baseline dependent on the length of the intervention according to participant needs).