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The Effectiveness and Mechanism of Character Strengths-based STEP Programme on Rehabilitation of Stroke Patients (STEP)

Primary Purpose

Stroke, Intervention, Rehabilitation

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Character strengths-based structured treatment and education programme (CSSTEP)
Structured treatment and education programme (STEP)
Sponsored by
Peking University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stroke focused on measuring Stroke, Chronic illness management, Intervention, Post-stroke depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: ① Clinical diagnosis of stroke, CT or MRI diagnosis of cerebral infarction; ② Within 30 days after clinical diagnosis of acute stroke; ③ Age ≥18 years; ④ Basic cognition, learning ability and willingness, all vital signs were stable, no other serious complications and no history of mental illness; ⑤ Informed consent and cooperation. Exclusion Criteria: ① Moderate or severe cognitive impairment (defined as mini-mental state examination score ≤20); ② Unstable vital signs, accompanied by severe heart, liver, renal insufficiency, respiratory failure and malignant tumors, unable to intervene.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    CSSTEP Group

    Control Group

    Arm Description

    On the basis of routine post-stroke care, the CSSTEP programme was added for a total of three weeks. Each week includes one session course and three after-session strengths-based practicing activities. The names of the three sessions are: 1. Individualised education on character strengths and guidance on daily life skills in stroke; 2. Practicing activities on"three good things" of character strengths and physical rehabilitation training for stroke; 3. "New ways to use signature strengths" and secondary stroke prevention.

    On the basis of routine post-stroke care, the regular structured treatment and education programme will be comducted for a total of three weeks. Each week includes one session course of structured treatment and education programme.

    Outcomes

    Primary Outcome Measures

    Change from Baseline Depression at 1 month
    This outcome will be measured by a specific scale/questionnaire, which is Hamilton Depression Scale (HAMD-24) Scale.

    Secondary Outcome Measures

    Change from Baseline Self-esteem at 1 month
    This outcome will be measured by a specific scale/questionnaire, which is Rosenberg Self-esteem Scale (RSES) Scale
    Change from Baseline Neurological function at 1 month
    This outcome will be measured by a specific scale/questionnaire, which is National Institutes of Health Stroke Scale (NIHSS) Scale
    Change from Baseline Cognitive function at 1 month
    This outcome will be measured by a specific scale/questionnaire, which is Mini-mental State Examination (MMSE) Scale
    Change from Baseline Gait speed at 1 month
    This outcome will be measured by participants walking 10 metres with the camera filming the recording, recording the time taken and finally dividing the length of 10 metres by the time to obtain the average speed of the walk. The gait speed was measured in metres per second, which is m/sec. The results and data includes video of participants and gait speed.

    Full Information

    First Posted
    December 16, 2022
    Last Updated
    February 18, 2023
    Sponsor
    Peking University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05738499
    Brief Title
    The Effectiveness and Mechanism of Character Strengths-based STEP Programme on Rehabilitation of Stroke Patients
    Acronym
    STEP
    Official Title
    The Effectiveness and Mechanism of Character Strengths-based Structured Treatment and Education Programme on Rehabilitation of Stroke Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 30, 2023 (Anticipated)
    Primary Completion Date
    July 30, 2023 (Anticipated)
    Study Completion Date
    October 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Peking University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    There is an urgent need for educational and psychological adjustment to stimulate the post-stroke patients' motivation to actively carry out rehabilitation. Studies have shown that interventions based on character strengths are widely used in chronic disease patients abroad, and have achieved the effect of improving the physical and mental health. However, research on individualized character strengths in stroke patient intervention is limited, and more clinical evidence is needed. This study is based on personality theory and the application of character strengths-based STEP programme (CSSTEP) in stroke patients. The investigators hypothesized that the CSSTEP programme could help stroke patients to improve mental state, cognitive function, and better gait performance, suffer from less post-stroke depression, enhance their post-stroke self-confidence.
    Detailed Description
    Post-stroke patients are often accompanied by different degrees of cognitive and language impairments. About 45% of the patients have persistent limb dysfunction, which leads to strong psychological stress reactions in patients, and negative emotions such as anxiety and depression are common. There is an urgent need for educational and psychological adjustment to stimulate the patient's motivation to actively carry out rehabilitation, so as to reduce negative emotions, enhance the patient's intrinsic motivation for rehabilitation, and reduce the patient's disability. Studies have shown that interventions based on character strengths are widely used in chronic disease patients abroad, and have achieved the effect of improving the physical and mental health of patients. However, research on individualized character strengths in stroke patient intervention is limited, and more clinical evidence is needed. This study is based on personality theory and the application of character strengths-based STEP programme (CSSTEP) in stroke patients. The investigators hypothesized that the CSSTEP programme could help stroke patients to improve mental state, cognitive function, and better gait performance, suffer from less post-stroke depression, enhance their post-stroke self-confidence. In addition, the investigators will use the application of CSSTEP in stroke care to provide a theoretical basis for a new personality direction for clinical psychological intervention, and provide new ideas and ideas for improving the stroke rehabilitation system and establishing a new personalized post-stroke intervention.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke, Intervention, Rehabilitation, Depression
    Keywords
    Stroke, Chronic illness management, Intervention, Post-stroke depression

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    172 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    CSSTEP Group
    Arm Type
    Experimental
    Arm Description
    On the basis of routine post-stroke care, the CSSTEP programme was added for a total of three weeks. Each week includes one session course and three after-session strengths-based practicing activities. The names of the three sessions are: 1. Individualised education on character strengths and guidance on daily life skills in stroke; 2. Practicing activities on"three good things" of character strengths and physical rehabilitation training for stroke; 3. "New ways to use signature strengths" and secondary stroke prevention.
    Arm Title
    Control Group
    Arm Type
    Placebo Comparator
    Arm Description
    On the basis of routine post-stroke care, the regular structured treatment and education programme will be comducted for a total of three weeks. Each week includes one session course of structured treatment and education programme.
    Intervention Type
    Other
    Intervention Name(s)
    Character strengths-based structured treatment and education programme (CSSTEP)
    Other Intervention Name(s)
    Psycho-educational intervention
    Intervention Description
    This CSSTEP intervention included both psychological and educational contents, and the intervention type was psycho-educational intervention. The implementation process lasted for three weeks. CSSTEP mainly includes two main components. The first part is character strengths-based intervention. The second part is educational intervention, which is structured treatment and education programme for stroke patients. The two components were combined and optimized on the basis of theoritical and empirical evidences, and then this kind of complex intervention suitable for Chinese clinical stroke patients was obtained.
    Intervention Type
    Other
    Intervention Name(s)
    Structured treatment and education programme (STEP)
    Other Intervention Name(s)
    Educational intervention
    Intervention Description
    The STEP programme is aimed at the treatment needs of stroke patients, considering the education level and cultural background of patients, screening important health education content, and planning and grading of patients' education. The intervention consisted of three educational sessions, focusing on patients' daily life, post-stroke rehabilitation and secondary prevention.
    Primary Outcome Measure Information:
    Title
    Change from Baseline Depression at 1 month
    Description
    This outcome will be measured by a specific scale/questionnaire, which is Hamilton Depression Scale (HAMD-24) Scale.
    Time Frame
    Baseline, Post-intervention within one week, One month after intervention
    Secondary Outcome Measure Information:
    Title
    Change from Baseline Self-esteem at 1 month
    Description
    This outcome will be measured by a specific scale/questionnaire, which is Rosenberg Self-esteem Scale (RSES) Scale
    Time Frame
    Baseline, Post-intervention within one week, One month after intervention
    Title
    Change from Baseline Neurological function at 1 month
    Description
    This outcome will be measured by a specific scale/questionnaire, which is National Institutes of Health Stroke Scale (NIHSS) Scale
    Time Frame
    Baseline, Post-intervention within one week, One month after intervention
    Title
    Change from Baseline Cognitive function at 1 month
    Description
    This outcome will be measured by a specific scale/questionnaire, which is Mini-mental State Examination (MMSE) Scale
    Time Frame
    Baseline, Post-intervention within one week, One month after intervention
    Title
    Change from Baseline Gait speed at 1 month
    Description
    This outcome will be measured by participants walking 10 metres with the camera filming the recording, recording the time taken and finally dividing the length of 10 metres by the time to obtain the average speed of the walk. The gait speed was measured in metres per second, which is m/sec. The results and data includes video of participants and gait speed.
    Time Frame
    Baseline, Post-intervention within one week, One month after intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: ① Clinical diagnosis of stroke, CT or MRI diagnosis of cerebral infarction; ② Within 30 days after clinical diagnosis of acute stroke; ③ Age ≥18 years; ④ Basic cognition, learning ability and willingness, all vital signs were stable, no other serious complications and no history of mental illness; ⑤ Informed consent and cooperation. Exclusion Criteria: ① Moderate or severe cognitive impairment (defined as mini-mental state examination score ≤20); ② Unstable vital signs, accompanied by severe heart, liver, renal insufficiency, respiratory failure and malignant tumors, unable to intervene.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tingting YAN, PhD
    Phone
    +86 15890698392
    Email
    ttyan@bjmu.edu.cn
    First Name & Middle Initial & Last Name or Official Title & Degree
    Qi ZHANG, Master
    Phone
    +86 13011144071
    Email
    1252238060@qq.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Tingting YAN, PhD
    Organizational Affiliation
    Peking University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    32641444
    Citation
    Lou M, Ding J, Hu B, Zhang Y, Li H, Tan Z, Wan Y, Xu AD; Chinese Stroke Association Stroke Council Guideline Writing Committee. Chinese Stroke Association guidelines for clinical management of cerebrovascular disorders: executive summary and 2019 update on organizational stroke management. Stroke Vasc Neurol. 2020 Sep;5(3):260-269. doi: 10.1136/svn-2020-000355. Epub 2020 Jul 8.
    Results Reference
    background
    PubMed Identifier
    32101849
    Citation
    Kakuda W. [Future directions of stroke rehabilitation]. Rinsho Shinkeigaku. 2020 Mar 31;60(3):181-186. doi: 10.5692/clinicalneurol.cn-001399. Epub 2020 Feb 26. Japanese.
    Results Reference
    background
    PubMed Identifier
    29993937
    Citation
    Qian Z, Lv D, Lv Y, Bi Z. Modeling and Quantification of Impact of Psychological Factors on Rehabilitation of Stroke Patients. IEEE J Biomed Health Inform. 2019 Mar;23(2):683-692. doi: 10.1109/JBHI.2018.2827100. Epub 2018 Apr 16.
    Results Reference
    background
    PubMed Identifier
    58771
    Citation
    Rossignol S, Jones GM. Audio-spinal influence in man studied by the H-reflex and its possible role on rhythmic movements synchronized to sound. Electroencephalogr Clin Neurophysiol. 1976 Jul;41(1):83-92. doi: 10.1016/0013-4694(76)90217-0.
    Results Reference
    background
    PubMed Identifier
    21948939
    Citation
    Stahl B, Kotz SA, Henseler I, Turner R, Geyer S. Rhythm in disguise: why singing may not hold the key to recovery from aphasia. Brain. 2011 Oct;134(Pt 10):3083-93. doi: 10.1093/brain/awr240. Epub 2011 Sep 21.
    Results Reference
    background
    PubMed Identifier
    16859421
    Citation
    Van Vleet TM, Robertson LC. Cross-modal interactions in time and space: auditory influence on visual attention in hemispatial neglect. J Cogn Neurosci. 2006 Aug;18(8):1368-79. doi: 10.1162/jocn.2006.18.8.1368.
    Results Reference
    background
    PubMed Identifier
    30263147
    Citation
    Patel K, Watkins CL, Sutton CJ, Holland EJ, Benedetto V, Auton MF, Barer D, Chatterjee K, Lightbody CE. Motivational interviewing for low mood and adjustment early after stroke: a feasibility randomised trial. Pilot Feasibility Stud. 2018 Sep 25;4:152. doi: 10.1186/s40814-018-0343-z. eCollection 2018.
    Results Reference
    background
    PubMed Identifier
    21700946
    Citation
    Watkins CL, Wathan JV, Leathley MJ, Auton MF, Deans CF, Dickinson HA, Jack CI, Sutton CJ, van den Broek MD, Lightbody CE. The 12-month effects of early motivational interviewing after acute stroke: a randomized controlled trial. Stroke. 2011 Jul;42(7):1956-61. doi: 10.1161/STROKEAHA.110.602227. Epub 2011 Jun 23.
    Results Reference
    background
    PubMed Identifier
    24203126
    Citation
    Jokela M, Pulkki-Raback L, Elovainio M, Kivimaki M. Personality traits as risk factors for stroke and coronary heart disease mortality: pooled analysis of three cohort studies. J Behav Med. 2014 Oct;37(5):881-9. doi: 10.1007/s10865-013-9548-z. Epub 2013 Nov 8.
    Results Reference
    background
    PubMed Identifier
    23871119
    Citation
    Afanasiev S, Aharon-Peretz J, Granot M. Personality type as a predictor for depressive symptoms and reduction in quality of life among stroke survivals. Am J Geriatr Psychiatry. 2013 Sep;21(9):832-9. doi: 10.1016/j.jagp.2013.04.012. Epub 2013 Jul 17.
    Results Reference
    background
    PubMed Identifier
    32187708
    Citation
    Yan T, Chan CWH, Chow KM, Zheng W, Sun M. A systematic review of the effects of character strengths-based intervention on the psychological well-being of patients suffering from chronic illnesses. J Adv Nurs. 2020 Jul;76(7):1567-1580. doi: 10.1111/jan.14356. Epub 2020 Apr 7.
    Results Reference
    background

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