Piloting the Attention Training Technique for Post-Stroke Emotionalism

NCT06457126 | Not Yet Recruiting

• 1 other identifier: 333045
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

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. 1.c. Is the ATT associated with an improvement of PSE symptoms when some parameters (e.g., frequency and dose) are modified?
2. 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))?

Conditions

Stroke; Emotionality; Pseudobulbar Affect; Lability Emotional; Crying

Keywords

Stroke; Post Stroke Emotionalism; Attention Training Technique; Crying Symptoms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• The Hospital Anxiety and Depression Scale (HADS)

  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)

  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)

  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

  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)

  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 (1)

• Post-Intervention Interview

  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).

Study Arms (1)

Attention Training Technique

EXPERIMENTAL

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

Interventions

Attention Training Technique BEHAVIORAL

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

Attention Training Technique

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Manchester: lead
• Manchester University NHS Foundation Trust: collaborator
• Northern Care Alliance NHS Foundation Trust: collaborator

Study Sites (2)

Manchester University NHS Foundation Trust

Manchester, United Kingdom

Location

Northern Care Alliance

Manchester, United Kingdom

Location

Related Publications (11)

• Barlow, D., Nock, M., & Hersen, M. (2009) Single Case Experimental Design: Strategies for Studying Behaviour Change (3rd ed.) Pearson.

  BACKGROUND

• Broomfield NM, West R, House A, Munyombwe T, Barber M, Gracey F, Gillespie DC, Walters M. Psychometric evaluation of a newly developed measure of emotionalism after stroke (TEARS-Q). Clin Rehabil. 2021 Jun;35(6):894-903. doi: 10.1177/0269215520981727. Epub 2020 Dec 21.

  PMID: 33345598 BACKGROUND

• Broomfield NM, West R, Barber M, Quinn TJ, Gillespie D, Walters M, House A. TEARS: a longitudinal investigation of the prevalence, psychological associations and trajectory of poststroke emotionalism. J Neurol Neurosurg Psychiatry. 2022 Apr 28:jnnp-2022-329042. doi: 10.1136/jnnp-2022-329042. Online ahead of print.

  PMID: 35483914 BACKGROUND

• Fitzgerald S, Gracey F, Broomfield N. Post-stroke emotionalism (PSE): a qualitative longitudinal study exploring individuals' experience with PSE. Disabil Rehabil. 2022 Dec;44(25):7891-7903. doi: 10.1080/09638288.2021.2002439. Epub 2021 Nov 16.

  PMID: 34784814 BACKGROUND

• Fitzgerald S, Gracey F, Trigg E, Broomfield N. Predictors and correlates of emotionalism across acquired and progressive neurological conditions: A systematic review. Neuropsychol Rehabil. 2023 Jun;33(5):945-987. doi: 10.1080/09602011.2022.2052326. Epub 2022 Mar 24.

  PMID: 35323084 BACKGROUND

• Gillespie DC, Cadden AP, West RM, Broomfield NM. Non-pharmacological interventions for post-stroke emotionalism (PSE) within inpatient stroke settings: a theory of planned behavior survey. Top Stroke Rehabil. 2020 Jan;27(1):15-24. doi: 10.1080/10749357.2019.1654241. Epub 2019 Aug 28.

  PMID: 31461389 BACKGROUND

• Gillespie DC, Halai AD, West RM, Dickie DA, Walters M, Broomfield NM. Demographic, clinical and neuroimaging markers of post-stroke emotionalism: A preliminary investigation. J Neurol Sci. 2022 May 15;436:120229. doi: 10.1016/j.jns.2022.120229. Epub 2022 Mar 21.

  PMID: 35378397 BACKGROUND

• Knowles MM, Foden P, El-Deredy W, Wells A. A Systematic Review of Efficacy of the Attention Training Technique in Clinical and Nonclinical Samples. J Clin Psychol. 2016 Oct;72(10):999-1025. doi: 10.1002/jclp.22312. Epub 2016 Apr 29.

  PMID: 27129094 BACKGROUND

• McAleese N, Guzman A, O'Rourke SJ, Gillespie DC. Post-stroke emotionalism: a qualitative investigation. Disabil Rehabil. 2021 Jan;43(2):192-200. doi: 10.1080/09638288.2019.1620876. Epub 2019 May 28.

  PMID: 31136206 BACKGROUND

• Wells, A. (1990). Panic disorder in association with relaxation induced anxiety: An attentional training approach to treatment. Behavior therapy, 21(3), 273-280. https://doi.org/10.1016/S0005-7894(05)80330-2

  BACKGROUND

• Wells A. Breaking the Cybernetic Code: Understanding and Treating the Human Metacognitive Control System to Enhance Mental Health. Front Psychol. 2019 Dec 12;10:2621. doi: 10.3389/fpsyg.2019.02621. eCollection 2019.

  PMID: 31920769 BACKGROUND

MeSH Terms

Conditions

Stroke; Crying

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Nonverbal Communication; Communication; Behavior

Study Officials

• Adrian Wells

  University of Manchester

  STUDY DIRECTOR

Central Study Contacts

Clair Davison

CONTACT

0161 306 0400; clair.davison@postgrad.manchester.ac.uk

Adrian Wells

CONTACT

0161 306 0400; adrian.wells@manchester.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: June 13, 2024
• Study Start: June 24, 2024
• Primary Completion: April 30, 2025
• Study Completion: August 30, 2025
• Last Updated: June 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)