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

Stroke Clinical Trial

— STEP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05738499
• Other study ID #: IRB00001052-22116
• Status: Recruiting
• Phase: N/A
• Start date: April 30, 2023
• Est. completion date: December 30, 2023

Study information

• Verified date: November 2023
• Source: Peking University
• Contact: Tingting YAN, PhD
• Phone: +86 15890698392
• Email: ttyan[@]bjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 172
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• ? Clinical diagnosis of stroke, CT or MRI diagnosis of cerebral infarction;

• ? Within 30 days after clinical diagnosis of acute stroke;

• ? Age =18 years;

• ? Basic cognition, learning ability and willingness, all vital signs were stable, no other serious complications and no history of mental illness;

• ? Informed consent and cooperation.

Exclusion Criteria:

• ? Moderate or severe cognitive impairment (defined as mini-mental state examination score =20);

• ? Unstable vital signs, accompanied by severe heart, liver, renal insufficiency, respiratory failure and malignant tumors, unable to intervene.

Related Conditions & MeSH terms

• Depression
• Intervention
• Rehabilitation
• Stroke

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	The Secind Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

References & Publications (11)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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