Applying the Metacognitive Model to Post-Stroke Emotionalism: A Multiphasic Case Series Piloting the Attention Training Technique
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Daily Diaries - Stroke Survivor and Carer
研究概览
简要总结
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: 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:
- 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?
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
Daily Diaries - Stroke Survivor and Carer
时间窗: 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).
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.
次要结局
- 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).)
- 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).)
研究者
Adrian Wells
Professor
University of Manchester