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

NCT ID: NCT05738499

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 172 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-30
• Study Completion Date: 2023-12-30

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.

Conditions

Stroke; Intervention; Rehabilitation; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

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.

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.

Group Type: PLACEBO_COMPARATOR

Structured treatment and education programme (STEP)

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

Psycho-educational intervention; Educational intervention

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University

OTHER

Sponsor Role: lead

Responsible Party

YAN Tingting, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tingting YAN, PhD

Role: PRINCIPAL_INVESTIGATOR

Peking University

Locations

The Secind Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Tingting YAN, PhD

Role: CONTACT

ttyan@bjmu.edu.cn

+86 15890698392

Dandan Wang, Master

Role: CONTACT

1252238060@qq.com

+86 13011144071

Facility Contacts

Dandan Wang, Master

Role: primary

realityru22@qq.com

18737389725

References

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.

Reference Type: BACKGROUND

PMID: 32187708 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32641444 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32101849 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29993937 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 58771 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21948939 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16859421 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30263147 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21700946 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24203126 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23871119 (View on PubMed)

Other Identifiers

IRB00001052-22116

Identifier Type: -

Identifier Source: org_study_id