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

Peking University

Status: Enrolling

Conditions: Rehabilitation; Stroke; Intervention; Depression

Treatments: Other: Structured treatment and education programme (STEP); Other: Character strengths-based structured treatment and education programme (CSSTEP)

Study type: Interventional

Funder types: Other

Identifiers

NCT05738499

IRB00001052-22116

Details and patient eligibility

About

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.

Full 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.

Enrollment: 172 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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172 participants in 2 patient groups, including a placebo group

CSSTEP Group

Experimental group

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.

Treatment:

Other: Character strengths-based structured treatment and education programme (CSSTEP)

Control Group

Placebo Comparator group

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.

Treatment:

Other: Structured treatment and education programme (STEP)