Clinical trial NCT05738499: The Effectiveness and Mechanism of Character Strengths-based STEP Programme on Rehabilitation of Stroke Patients
Official title: The Effectiveness and Mechanism of Character Strengths-based Structured Treatment and Education Programme on Rehabilitation of Stroke Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Intervention
Rehabilitation
Depression
Keywords: Stroke
Chronic illness management
Intervention
Post-stroke depression
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2023-02-22
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Change from Baseline Depression at 1 month. Hamilton Depression Scale (HAMD-24) Scale
timeFrame: Baseline, Post-intervention within one week, One month after intervention
Secondary outcomes:
measure: Change from Baseline Self-esteem at 1 month. Rosenberg Self-esteem Scale (RSES) Scale
timeFrame: Baseline, Post-intervention within one week, One month after intervention
measure: Change from Baseline Neurological function at 1 month. National Institutes of Health Stroke Scale (NIHSS) Scale
timeFrame: Baseline, Post-intervention within one week, One month after intervention
measure: Change from Baseline Cognitive function at 1 month. Mini-mental State Examination (MMSE) Scale
timeFrame: Baseline, Post-intervention within one week, One month after intervention
measure: Change from Baseline Gait speed at 1 month
timeFrame: Baseline, Post-intervention within one week, One month after intervention
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: The Secind Affiliated Hospital of Zhengzhou University
state: Henan
Study officials:
affiliation: Peking University
name: Tingting YAN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.
citation: 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.
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.