Clinical trial NCT06457126: Piloting the Attention Training Technique for Post-Stroke Emotionalism
Official title: Applying the Metacognitive Model to Post-Stroke Emotionalism: A Multiphasic Case Series Piloting the Attention Training Technique
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Emotionality
Pseudobulbar Affect
Lability Emotional
Crying
Keywords: Stroke
Post Stroke Emotionalism
Attention Training Technique
Crying Symptoms
Lead sponsor: University of Manchester
Sponsor class: OTHER
Collaborators: name: Manchester University NHS Foundation Trust
name: Northern Care Alliance NHS Foundation Trust
First posted: 2024-06-13
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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?

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Confirmed primary clinical diagnosis of an ischemic or haemorrhagic stroke.
* At least six months or more post-stroke
* Reported/observed difficulties with symptoms of PSE (episodes of uncontrollable and unpredictable crying that is not mood congruent and happens in situations that the person would not have otherwise cried)
* Scores between 6-16 on the Testing Emotionalism after Stroke Questionnaire (TEARS-Q; Broomfield et al., 2021)
* Scores \> 25 on the Frenchay Aphasia Screening Test (FAST; Enderby, Wood, and Wade 1987).
* Aged 18 or over.
* Has the Mental Capacity (Mental Capacity Act, 2005) to provide informed consent.
* Has carer support and consents to their carer being involved.
* Proficient in English Language
* No anticipated changes to antidepressant medication (if applicable).

Exclusion Criteria:

* Less than six months post-stroke
* Presenting with PSE without a primary diagnosis of an ischemic or haemorrhagic stroke and/or as a result of another neurological condition.
* Hyper acutely or acutely unwell with concurrent medical conditions.
* Receiving palliative or end of life care.
* Severe or distressing behaviours that may impede on engagement or cause further distress.
* Visual or hearing impairment unable to be corrected.

Primary outcomes:
measure: Daily Diaries - Stroke Survivor and Carer
timeFrame: 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 outcomes:
measure: The Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline time one; Post-intervention (a minimum of four to eight weeks to a maximum of 15-weeks from end of baseline).
measure: The Oxford Cognitive Screen (OCS)
timeFrame: Baseline time one; Post-intervention (a minimum of four to eight weeks to a maximum of 15-weeks from end of baseline).
measure: World Health Organisation Quality of Life Scale (WHOQOL-BREF)
timeFrame: Baseline time one; Post-intervention (a minimum of four to eight weeks to a maximum of 15-weeks from end of baseline).
measure: Focus of Attention Rating Scale
timeFrame: Weekly during intervention (across a minimum of four to eight weeks to a maximum of 15-weeks).
measure: The Testing Emotionalism after Recent Stroke Questionnaire (TEARS-Q)
timeFrame: Screening appointment and post-intervention (ie., a minimum of four to eight weeks to a maximum of 15-weeks from end of baseline).
Other outcomes:
measure: Post-Intervention Interview
timeFrame: 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).
Locations:
city: Manchester
country: United Kingdom
facility: Manchester University NHS Foundation Trust
city: Manchester
country: United Kingdom
facility: Northern Care Alliance
Study officials:
affiliation: University of Manchester
name: Adrian Wells
role: STUDY_DIRECTOR
References:
citation: Barlow, D., Nock, M., & Hersen, M. (2009) Single Case Experimental Design: Strategies for Studying Behaviour Change (3rd ed.) Pearson.
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