Effect of a Self-Management Cycle Framework-based psychoeducational intervention on academic anxiety among medical students: a randomized controlled trial
| ISRCTN | ISRCTN11249540 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11249540 |
| Sponsor | Zunyi Medical University |
| Funder | Zunyi Medical University |
- Submission date
- 06/04/2026
- Registration date
- 08/04/2026
- Last edited
- 08/04/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Medical students often experience high levels of academic stress and anxiety, which can negatively affect their learning, well-being, and future professional performance. Although psychoeducation is commonly used to support student mental health, many programmes focus mainly on providing information and may not include structured practice or skill application. This study aims to evaluate whether a more structured approach can better support students in managing academic stress.
Who can participate?
Third-year medical students aged 18 years and over with higher levels of academic anxiety
What does the study involve?
Participants will complete a baseline assessment of academic anxiety, self-efficacy, and psychological resilience and will be randomly assigned to one of two groups. The intervention group will take part in an 8-week psychoeducational programme based on the Self-Management Cycle Framework (SMCF). This programme includes structured activities such as goal setting, skill practice, self-monitoring, and peer interaction. The control group will receive a lecture-based psychoeducation programme covering similar topics, such as stress management and emotional regulation, but without practical exercises or structured skill training. All participants will complete the same questionnaires again after the programme to assess changes in their mental health.
What are the possible benefits and risks of participating?
Participants may benefit from improved ability to manage academic stress, increased confidence in their learning, and better emotional resilience. There are minimal risks associated with participation. Some students may feel mild emotional discomfort when reflecting on their stress, but support will be available if needed.
Where is the study run from?
Zunyi Medical University (China)
When is the study starting and how long is it expected to run for?
September 2025 to December 2025
Who is funding the study?
Zunyi Medical University (China)
Who is the main contact?
Kun He, 317037645@qq.com
Contact information
Public, Scientific
No. 1399 Zhufeng Avenue
Zhuhai
519100
China
 ORCID ID |
0009-0006-2631-7569 |
|---|---|
| Phone | +86 (0)13726241275 |
| 317037645@qq.com |
Principal investigator
Srinakharinwirot University, 114 Sukhumvit 23, Wattana
Bangkok
10110
Thailand
| ORCID ID |
0000-0002-2906-9832 |
|---|---|
| Phone | +66 (0)2-649-5000 |
| chatchaie@g.swu.ac.th |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Open (masking not used) |
| Control | Active |
| Assignment | Parallel |
| Purpose | Prevention |
| Scientific title | A parallel-group randomized controlled trial evaluating a Self-Management Cycle Framework (SMCF)-based psychoeducational intervention versus wait-list control for reducing academic anxiety among third-year medical students in China |
| Study objectives | To evaluate the effectiveness of a psychoeducational intervention based on the Self-Management Cycle Framework (SMCF) in reducing academic anxiety and improving academic self-efficacy and psychological resilience among medical students. |
| Ethics approval(s) |
Approved 08/08/2025, Ethics Committee of The Fifth Affiliated Hospital of Zunyi Medical University, Zhuhai (No. 1439 Zhufeng Avenue, Doumen District, Zhuhai, 519100, China; +86 (0)756 627 7715; 2009kjk@163.com), ref: 2025KY0110 |
| Health condition(s) or problem(s) studied | Academic anxiety and related psychological factors (self-efficacy and psychological resilience) among medical students |
| Intervention | Participants will be randomly assigned to the intervention or control group in a 1:1 ratio using computer-generated permuted block randomisation with a fixed block size of 4. This will ensure balanced allocation between groups. Allocation will be concealed prior to assignment. The intervention group will receive a structured psychoeducational programme based on the Self-Management Cycle Framework (SMCF). The programme consists of 8 sessions delivered over 8 weeks (90 minutes per session) in a group format. The intervention includes modules on self-assessment, goal setting, strategic learning, behavioural implementation, monitoring and adjustment, and peer/community engagement. Techniques include cognitive restructuring, behavioural activation, mindfulness-based strategies, and structured self-monitoring. The control group will receive a structured didactic psychoeducation programme covering similar thematic content (e.g., academic stress, coping strategies, and emotional regulation). The programme will be delivered in a lecture-based format without guided behavioural practice, experiential exercises, peer interaction tasks, or structured feedback processes. In contrast to the SMCF-based intervention, the control condition does not include task-based skill application, in-session behavioural activation, or iterative monitoring and adjustment components. This study is conducted under the supervision of Associate Professor Dr Chatchai Ekpanyaskul, MD, Srinakharinwirot University, Thailand. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 04/12/2025 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 30 Years |
| Sex | All |
| Target sample size at registration | 128 |
| Total final enrolment | 128 |
| Key inclusion criteria | 1. Third-year clinical medicine undergraduate students enrolled at the Zhuhai campus of Zunyi Medical University, China. 2. Aged 18 years or above. 3. Able to understand the study procedures and provide informed consent. 4. Completed baseline screening assessments. 5. Ranked among the 128 students with the highest scores on the Academic Anxiety Scale (AAS) and eligible for the intervention phase. 6. Willing and able to attend the scheduled group sessions throughout the study period. |
| Key exclusion criteria | 1. Currently receiving structured psychological or psychiatric treatment targeting anxiety or related mental health problems during the study period. 2. History of diagnosed severe mental disorders (e.g., major depressive disorder, bipolar disorder, psychotic disorders) that may interfere with participation. 3. Severe physical or cognitive conditions that limit the ability to participate in group sessions or complete assessments. 4. Inability to attend scheduled intervention sessions or anticipated absence during the study period. 5. Incomplete or invalid baseline assessment data preventing eligibility determination. |
| Date of first enrolment | 29/09/2025 |
| Date of final enrolment | 15/10/2025 |
Locations
Countries of recruitment
- China
Study participating centre
Zhuhai
519041
China
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan | De-identified individual participant data (IPD) may be made available upon reasonable request to the corresponding author after publication of the study results. Data sharing will be subject to institutional approval, ethical considerations, and a formal data sharing agreement. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 07/04/2026 | No | No |
Additional files
- 49323_PROTOCOL.pdf
- Protocol file
Editorial Notes
07/04/2026: Study's existence confirmed by the Ethics Committee of The Fifth Affiliated Hospital of Zunyi Medical University, Zhuhai.
