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

November 15, 2023 updated by: YAN Tingting, PhD, Peking University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

172

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China
        • Recruiting
        • The Secind Affiliated Hospital of Zhengzhou University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CSSTEP Group
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.
Other: Character strengths-based structured treatment and education programme (CSSTEP)
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.
Other Names:
  • Psycho-educational intervention
Placebo Comparator: Control Group
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)
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.
Other Names:
  • Educational intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Depression at 1 month. Hamilton Depression Scale (HAMD-24) Scale
Time Frame: Baseline, Post-intervention within one week, One month after intervention
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 Gait speed at 1 month
Time Frame: Baseline, Post-intervention within one week, One month after intervention
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
Change from Baseline Self-esteem at 1 month. Rosenberg Self-esteem Scale (RSES) Scale
Time Frame: Baseline, Post-intervention within one week, One month after intervention
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
Time Frame: Baseline, Post-intervention within one week, One month after intervention
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
Time Frame: Baseline, Post-intervention within one week, One month after intervention
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University

Investigators

  • Principal Investigator: Tingting YAN, PhD, Peking University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2023

Primary Completion (Estimated)

December 30, 2023

Study Completion (Estimated)

December 30, 2023

Study Registration Dates

First Submitted

December 16, 2022

First Submitted That Met QC Criteria

February 18, 2023

First Posted (Actual)

February 22, 2023

Study Record Updates

Last Update Posted (Actual)

November 18, 2023

Last Update Submitted That Met QC Criteria

November 15, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00001052-22116

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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