Clinical Trials Directory

Trials / Completed

CompletedNCT07455123

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
Phase
N/A
Study type
Interventional
Enrollment
51 (actual)
Sponsor
Hacettepe University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALSelf-Management Programme for Chronic FatigueParticipants 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.

Timeline

Start date
2024-09-01
Primary completion
2024-10-01
Completion
2025-09-01
First posted
2026-03-06
Last updated
2026-03-06

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07455123. Inclusion in this directory is not an endorsement.