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

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effectiveness and Mechanism of Character Strengths-based Structured Treatment and Education Programme on Rehabilitation of Stroke Patients

Conditions
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Stroke, Intervention, Rehabilitation, Depression

Intervention / Treatment
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* Other: Character strengths-based structured treatment and education programme (CSSTEP)
* Other: Structured treatment and education programme (STEP)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CSSTEP Group<br>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 onthree good things of character strengths and physical rehabilitation training for stroke; 3. New ways to use signature strengths and secondary stroke prevention. | Other: Character strengths-based structured treatment and education programme (CSSTEP)<br>* 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.<br>* Other names: Psycho-educational intervention;|
| Placebo Comparator: Control Group<br>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. | Other: Structured treatment and education programme (STEP)<br>* 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.<br>* Other names: Educational intervention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Depression at 1 month. Hamilton Depression Scale (HAMD-24) Scale | This outcome will be measured by a specific scale/questionnaire, which is Hamilton Depression Scale (HAMD-24) Scale. Scores range from 0-52, higher scores mean worse outcome. | Baseline, Post-intervention within one week, One month after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Self-esteem at 1 month. Rosenberg Self-esteem Scale (RSES) Scale | This outcome will be measured by a specific scale/questionnaire, which is Rosenberg Self-esteem Scale (RSES) Scale. Scores range from 10-40, higher scores mean better outcome. | Baseline, Post-intervention within one week, One month after intervention | 
| Change from Baseline Neurological function at 1 month. National Institutes of Health Stroke Scale (NIHSS) Scale | This outcome will be measured by a specific scale/questionnaire, which is National Institutes of Health Stroke Scale (NIHSS) Scale. Scores range from 0-42, higher scores mean worse outcome. | Baseline, Post-intervention within one week, One month after intervention | 
| Change from Baseline Cognitive function at 1 month. Mini-mental State Examination (MMSE) Scale | This outcome will be measured by a specific scale/questionnaire, which is Mini-mental State Examination (MMSE) Scale. Scores range from 0-30, higher scores mean better outcome. | Baseline, Post-intervention within one week, One month after intervention | 
| 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. | Baseline, Post-intervention within one week, One month after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Chronic illness management, Intervention, Post-stroke depression