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Completed

NCT Number: NCT07455123

The Effect of a Self-Management Program in University Students

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.

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Key information

About this study

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:

  • a Demographic Information Form to collect socio-demographic and academic variables;
  • the Piper Fatigue Scale to assess multidimensional fatigue severity;
  • the Pittsburgh Sleep Quality Index to evaluate sleep quality and disturbances;
  • the Psychological Resilience Scale for Adults to measure resilience across multiple domains; and
  • the Occupational Balance Questionnaire to assess perceived balance in daily activities.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-Management Programme for Chronic Fatigue

Behavioral

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.

Primary outcomes

  1. Change in Fatigue Severity (Piper Fatigue Scale Total Score)

    Time frame: 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.

  2. Change in Sleep Quality (Pittsburgh Sleep Quality Index Total Score)

    Time frame: 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.

  3. Change in Psychological Resilience (Psychological Resilience Scale for Adults Total Score)

    Time frame: 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.

  4. Change in Occupational Balance (Occupational Balance Questionnaire Total Score)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Mar 6, 2026
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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