Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06457126
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-06-06
Brief Title:
Piloting the Attention Training Technique for Post-Stroke Emotionalism
Sponsor:
University of Manchester
Organization:
University of Manchester
Study Overview
Official Title:
Applying the Metacognitive Model to Post-Stroke Emotionalism A Multiphasic Case Series Piloting the Attention Training Technique
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 carerloved 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 eg 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 eg 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
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 eg 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 eg 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 carerloved 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 interventions 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 eg 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 toviews on the ATT intervention eg what they found helpful andor unhelpful This will only take place after the participant has completed their final intervention session
Sample and Recruitment
Participants will be stroke survivors who are presenting with PSE and an allocated carerloved 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 interventions 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 eg 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 toviews on the ATT intervention eg what they found helpful andor unhelpful This will only take place after the participant has completed their final intervention session
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None