AzTrials
AzTrials

StrokeSTEPNCT05738499

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

A study testing Character strengths-based structured treatment and education programme (CSSTEP) and Structured treatment and education programme (STEP) in people with Stroke and Intervention, run by Peking University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke, Intervention, Rehabilitation
What is being tested?
Character strengths-based structured treatment and education programme (CSSTEP) and Structured treatment and education programme (STEP)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
172 participants
Where
1 siteChina
Study dates
30 Apr 2023to 30 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Tingting YAN, PhD contact

+86 15890698392

ttyan@bjmu.edu.cn

Dandan Wang, Master contact

+86 13011144071

1252238060@qq.com

China1 site, 1 recruiting

  • The Secind Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

    Dandan Wang, Master, 18737389725, realityru22@qq.com

    Recruiting

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Character strengths-based structured treatment and education programme (CSSTEP), Structured treatment and education programme (STEP)
Keywords
Stroke, Chronic illness management, Intervention, Post-stroke depression
Medical subject headings
Stroke, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called Psycho-educational intervention

    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)Other

    Also called Educational intervention

    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.

Study groups in NCT05738499
Study groupRoleWhat they receive
CSSTEP GroupExperimentalOn 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.
Receives: Other: Character strengths-based structured treatment and education programme (CSSTEP)
Control GroupPlacebo comparatorOn 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.
Receives: Other: Structured treatment and education programme (STEP)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, Post-intervention within one week, One month after intervention

Secondary outcomes (4)

  1. 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.

    Measured: Baseline, Post-intervention within one week, One month after intervention

  2. 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.

    Measured: Baseline, Post-intervention within one week, One month after intervention

  3. 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.

    Measured: Baseline, Post-intervention within one week, One month after intervention

  4. 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.

    Measured: Baseline, Post-intervention within one week, One month after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2023
  2. Study start30 Apr 2023
  3. Primary completion30 Dec 2023 (estimated)
  4. Study completion30 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
172 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05738499
Sponsor's protocol ID
IRB00001052-22116
Acronym
STEP
Status last verified
Nov 2023
First submitted
16 Dec 2022
Last updated
18 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32641444

  • 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.

    PubMed 32101849

  • 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.

    PubMed 29993937

  • 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.

    PubMed 58771

  • 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.

    PubMed 21948939

  • 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.

    PubMed 16859421

  • 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.

    PubMed 30263147

  • 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.

    PubMed 21700946

  • 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.

    PubMed 24203126

  • 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.

    PubMed 23871119

  • 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.

    PubMed 32187708

Questions about this trial

What is this clinical trial studying?

A study testing Character strengths-based structured treatment and education programme (CSSTEP) and Structured treatment and education programme (STEP) in people with Stroke and Intervention, run by Peking University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Tingting YAN, PhD (+86 15890698392, ttyan@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05738499, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in