Piloting the Attention Training Technique for Post-Stroke Emotionalism

NCT06457126 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2024-06-13

No results posted yet for this study

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?

Conditions

  • Stroke
  • Emotionality
  • Pseudobulbar Affect
  • Lability Emotional
  • Crying

Interventions

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).

Sponsors & Collaborators

  • Manchester University NHS Foundation Trust

    collaborator OTHER_GOV
  • Northern Care Alliance NHS Foundation Trust

    collaborator OTHER
  • University of Manchester

    lead OTHER

Principal Investigators

  • Adrian Wells · University of Manchester

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-24
Primary Completion
2025-04-30
Completion
2025-08-30

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06457126 on ClinicalTrials.gov