The Effect of a Self-Management Program on Fatigue, Sleep Quality, Psychological Resilience, and Occupational Balance in University Students With High Levels of Fatigue: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Change in Fatigue Severity (Piper Fatigue Scale Total Score)
研究概览
简要总结
This study will be conducted as a randomized controlled pre-post test trial designed in accordance with the CONSORT guidelines. University students with chronic fatigue will be invited to participate; eligible participants will be assigned to the intervention and control groups using a block randomization method. Based on the power analysis, a minimum of 50 participants will be targeted. The intervention group will receive a 12-week Self-Management Programme (SMP), consisting of one session per week (a total of 12 hours). The control group will receive a single informational session. The SMP will focus on developing skills such as goal setting, time management, stress coping, self-motivation, problem solving, energy awareness, and activity planning. The program content will be structured based on self-management models described in the literature, including CDSMP, OPTIMAL, and MAP.
Assessments will be conducted before the intervention and at the end of the 12th week. Data collection tools will include a Demographic Information Form, the Piper Fatigue Scale, the Pittsburgh Sleep Quality Index, the Psychological Resilience Scale for Adults, and the Occupational Balance Questionnaire.
详细描述
This study will be conducted as a randomized controlled pre-post test trial designed in accordance with the CONSORT guidelines. University students experiencing chronic fatigue will be invited to participate through written announcements at a state university. Eligibility criteria will include being 18 years of age or older, having sufficient proficiency in Turkish to complete the assessment tools, and scoring 4 or above (indicating at least moderate fatigue) on the Piper Fatigue Scale. Students who are employed part-time or full-time in addition to their education or who report any diagnosed chronic medical or psychiatric conditions will be excluded to control for potential confounding factors.
Following baseline assessment, eligible participants will be randomly allocated to either the intervention or control group using a block randomization method to ensure balanced group sizes. Randomization will be conducted via an online randomization software. Based on an a priori power analysis (Cohen's d = 0.35, α = 0.05, power = 80%, two groups), the minimum required sample size will be 50 participants.
The intervention group will receive a 12-week Self-Management Programme (SMP), consisting of one 60-minute session per week (total of 12 sessions). The control group will receive a single structured informational session on self-management principles without ongoing training or follow-up support. The SMP will be delivered by an experienced practitioner and will incorporate interactive components such as guided discussions, self-reflection exercises, fatigue diaries, and practical applications.
The SMP will aim to enhance participants' ability to manage the physical, cognitive, and emotional demands associated with chronic fatigue. Core components will include goal setting, time and energy management, stress coping strategies, self-motivation techniques, problem-solving skills, awareness of activity-rest balance, behavioral activation, and the development of sustainable daily routines. The content of the program will be structured based on established self-management models in the literature, including the Chronic Disease Self-Management Program (CDSMP), OPTIMAL, and the Movement through Active Personalised Engagement (MAP) program. Emphasis will be placed on energy conservation, activity planning, structured rest strategies, and strengthening psychological resilience.
Assessments will be conducted at baseline (prior to the intervention) and at the end of the 12th week. All questionnaires will be administered under standardized conditions to minimize peer influence and measurement bias.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Being 18 years of age or older
- •Being enrolled as a university student
- •Ability to read and understand Turkish
- •Scoring ≥4 (moderate fatigue or higher) on the Piper Fatigue Scale
- •Providing written informed consent
排除标准
- •Having a diagnosed chronic medical condition (e.g., neurological, autoimmune, endocrine, or other chronic systemic diseases)
- •Having a diagnosed psychiatric disorder
- •Being employed part-time or full-time in addition to university education
- •Currently receiving structured psychological or behavioral intervention related to fatigue management
- •Inability to complete assessment forms
研究组 & 干预措施
Self-Management Programme (SMP)
Participants in this arm will receive a 12-week Self-Management Programme consisting of one 60-minute session per week (total 12 sessions). The program will include goal setting, energy and time management, stress coping strategies, problem-solving skills, activity planning, and behavioral activation techniques aimed at improving fatigue management, sleep quality, psychological resilience, and occupational balance.
干预措施: Self-Management Programme for Chronic Fatigue (Behavioral)
Control - Information Session
No intervention group
结局指标
主要结局
Change in Fatigue Severity (Piper Fatigue Scale Total Score)
时间窗: Baseline and Week 12
Fatigue severity is assessed using the Piper Fatigue Scale total score. The scale evaluates multidimensional fatigue across behavioral, affective, sensory, and cognitive domains. Higher scores indicate greater fatigue severity. The primary outcome is the between-group difference in change in total score from baseline to week 12.
Change in Sleep Quality (Pittsburgh Sleep Quality Index Total Score)
时间窗: Baseline and Week 12
Sleep quality is assessed using the Pittsburgh Sleep Quality Index (PSQI). The scale evaluates subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Higher total scores indicate poorer sleep quality. The outcome is the between-group difference in change in total score from baseline to week 12.
Change in Psychological Resilience (Psychological Resilience Scale for Adults Total Score)
时间窗: Baseline and Week 12
Psychological resilience is assessed using the Psychological Resilience Scale for Adults. The scale measures structural style, future perception, family cohesion, self-perception, social competence, and social resources. Higher scores indicate greater psychological resilience. The outcome is the between-group difference in change in total score from baseline to week 12.
Change in Occupational Balance (Occupational Balance Questionnaire Total Score)
时间窗: Baseline and Week 12
Occupational balance is assessed using the Occupational Balance Questionnaire (OBQ). The questionnaire evaluates perceived balance among meaningful daily activities. Lower total scores indicate better occupational balance. The outcome is the between-group difference in change in total score from baseline to week 12.
次要结局
未报告次要终点
研究者
Medine Nur Özata Değerli
MSc. Occupational Therapist, Research Assistant
Hacettepe University