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The Effect of a Self-Management Program in University Students

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07455123
Enrollment
51
Registered
2026-03-06
Start date
2024-09-01
Completion date
2025-09-01
Last updated
2026-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fatigue Syndrome, Chronic

Keywords

Chronic fatigue, self-management, occupational balance, psychological resilience, quality of sleep

Brief summary

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.

Detailed description

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. Data collection instruments will include: 1. a Demographic Information Form to collect socio-demographic and academic variables; 2. the Piper Fatigue Scale to assess multidimensional fatigue severity; 3. the Pittsburgh Sleep Quality Index to evaluate sleep quality and disturbances; 4. the Psychological Resilience Scale for Adults to measure resilience across multiple domains; and 5. the Occupational Balance Questionnaire to assess perceived balance in daily activities.

Interventions

BEHAVIORALSelf-Management Programme for Chronic Fatigue

Participants will receive a 12-week structured Self-Management Programme consisting of one 60-minute session per week. The program includes goal setting, energy conservation strategies, time management, stress coping techniques, problem-solving skills, activity planning, fatigue monitoring, and behavioral activation components. The intervention is designed to improve fatigue management, sleep quality, psychological resilience, and occupational balance among university students with chronic fatigue.

Sponsors

Hacettepe University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Change in Fatigue Severity (Piper Fatigue Scale Total Score)Baseline and Week 12Fatigue 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)Baseline and Week 12Sleep 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)Baseline and Week 12Psychological 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)Baseline and Week 12Occupational 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026