An interventional study of Attention Training Technique in Stroke, Emotionality and Pseudobulbar Affect, sponsored by University of Manchester. Not yet recruiting at 2 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-13.
Sponsored by University of Manchester · Not applicable, Interventional, and Treatment
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:
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:
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:
This study is a multi-phasic systematic case series piloting the ATT with stroke survivors presenting with PSE across two phases with extended baselines (A). Phase 1 will utilise a non-concurrent multiple baseline AB design where the ATT (B) is introduced sequentially across participants. Phase 2 will utilise an alternating treatment design where the ATT is compared to a passive listening task (C). To do this, each intervention will be rapidly and frequently alternated within the same participant (ABACA or ACABA). Participants in Phase 2 will be randomised to a predetermined treatment block over a time-limited period; the length of which will be informed by findings in Phase 1.
Sample and Recruitment:
Participants will be stroke survivors who are presenting with PSE and an allocated carer/loved one to support each stroke survivor. As differentiating between PSE and adjustment- distress is difficult during the acute phases of recovery, this study will only recruit people who are at least six months post-stroke.
Stroke survivor participants will be recruited from post-acute community stroke services. Participants will be identified by stroke clinicians during routine clinical practice. They will share this information to service-users and their carers who meet the inclusion criteria as part of their routine care. A Consent to Contact form and Eligibility Form will be completed by the clinician where participants and their carers consent to be contacted by a member of the research team. Those who provide permission to be contacted and are identified by the clinical care team as eligible for screening will be contacted in-person or by email, telephone, or video-call (according to their preference). The initial contact will provide further information about the study, answer any questions and to arrange a screening appointment if they wish to proceed.
Eligibility Screening:
A screening appointment will be organised with interested participants. This will include administration of two screening measures: the TEARS-Q and FAST to determine stroke survivor eligibility for participation. The data obtained initially from these measures will be to ascertain eligibility and not form part of the research data set. If eligible, participants and their carer will be provided with an accessible Participant Information Sheet to enable them to make an informed decision about participation. Follow-up contact will be made one week after the screening appointment, if no response has been received, to provide an opportunity to answer any questions, provide further information about what is entailed and to allow the service-user time to consider whether they would like to take part. If the service-user decides to take part, an initial appointment will be made to take written informed consent using the Consent Form, further explain the protocol for participation and to start the collection of baseline data. Throughout the consenting process, consent will be sought to use the screening measure data as part of the research dataset.
Extended Baseline - Phase 1 and 2:
In the first appointment, participants will be reminded of the study protocol and that the intervention(s) are individual techniques that do not equate to formal therapy. Risk-assessments and distress-management plans will be in place to support participants if they are needed. Participants and their carer will be shown how to complete the PSE primary outcome measures (the daily diaries). Compensatory strategies (e.g., reminders or alarms) will be discussed and tailored to the participants' needs, if required. Pre-intervention measures will be administered. These include: OCS; HADS and WHOQOL-BREF. Relevant demographic information of each participant will be collected using a bespoke demographic questionnaire. This will include data about their age, gender, marital status, nature of their stroke, physical and mental health and medical etc. Subsequent weekly contact will not provide any therapeutic instruction and only collect the daily diary measure data from the participant and their carer. This will continue until stable trends in PSE symptoms are observed for at least three data points.
Intervention:
Phase 1 - The first session will present the participant with a rationale for using the ATT to manage PSE. The pre- intervention credibility questionnaire will be administered. An audio-recorded version of the ATT will then be introduced. Daily diary measure data will be collected from the participant and their carer. Subsequent weekly sessions will include further practice of the ATT and the collection of the daily diary measure data. At least four to eight sessions of the ATT will be administered given the minimally effective dose is four (Heitland et al., 2020). This will continue until stable effects in the data are observed.
Phase 2 - A randomisation procedure will allocate each participant to a predetermined treatment sequence to ascertain which intervention they start with. The first intervention session will provide the participant with a rationale for using either the active ATT (follow the instructions) or passive ATT (do not follow the instructions). The order of the interventions will be randomised and counterbalanced across participants. The pre-intervention credibility questionnaire will be administered. Participants will then be taught both interventions using audio recordings of each in subsequent sessions. The daily diary measure data will be collected at each contact. At the end of predetermined study sequence, participants will be asked about their experience of each intervention and their preferences.
Post-Intervention measures will then be administered in both Phase 1 and 2 in the final intervention session. Again, these include: OCS; HADS and WHOQOL-BREF. The TEARS-Q will also be repeated at this point to ascertain whether there has been any change in their PSE symptoms. The post-intervention credibility questionnaire will also be administered in the last intervention session.
Post-Intervention Interview - Phase 1 and 2:
This will be an optional brief semi-structured interview exploring participants' reaction to/views on the ATT intervention (e.g., what they found helpful and/or unhelpful). This will only take place after the participant has completed their final intervention session.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's planned enrollment of 14 is below the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →University of Manchester is the lead sponsor of 194 studies on the registry; 43 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
An audio-recorded 12-minute version will be used and administered with permission and training from the creator of the Attention Training Technique (Professor Adrian Wells). At least four to eight sessions will be administered, given the minimally effective dose is four. Administration will continue until stable effects in the data are observed.
Behavioral: Attention Training Technique
Phase 1: Non-concurrent multiple baseline design A-B design where the ATT (B) is introduced sequentially across participants. ATT and baseline (A) will be alternated on a weekly basis. Phase 2: Alternating treatment design where an active (B) and passive (C) version of the ATT are rapidly and frequently alternative within the same participant on a weekly basis (e.g., A-B-A-C-A or A-C-A-B-A).
Also known as: ATT
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.
Time frame: 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).
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Screening appointment and post-intervention (ie., a minimum of four to eight weeks to a maximum of 15-weeks from end of baseline).
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).
Time frame: 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).
Plan to share: No
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University of Manchester