NCT07455123

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 6, 2026

Completed
Last Updated

March 6, 2026

Status Verified

March 1, 2026

Enrollment Period

1 month

First QC Date

March 2, 2026

Last Update Submit

March 5, 2026

Conditions

Keywords

Chronic fatigueself-managementoccupational balancepsychological resiliencequality of sleep

Outcome Measures

Primary Outcomes (4)

  • Change in Fatigue Severity (Piper Fatigue Scale Total Score)

    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.

    Baseline and Week 12

  • Change in Sleep Quality (Pittsburgh Sleep Quality Index Total Score)

    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.

    Baseline and Week 12

  • Change in Psychological Resilience (Psychological Resilience Scale for Adults Total Score)

    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.

    Baseline and Week 12

  • Change in Occupational Balance (Occupational Balance Questionnaire Total Score)

    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.

    Baseline and Week 12

Study Arms (2)

Self-Management Programme (SMP)

EXPERIMENTAL

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.

Behavioral: Self-Management Programme for Chronic Fatigue

Control - Information Session

NO INTERVENTION

No intervention group

Interventions

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.

Self-Management Programme (SMP)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

Related Publications (5)

  • olmefur, M., Roshanay, A., White, S., Janeslätt, G., Vimefall, E., & Lidström-Holmqvist, K. (2021). Evaluation of the "Let's Get Organized" group intervention to improve time management: protocol for a multi-centre randomised controlled trial. Trials, 22(1), 640

    BACKGROUND
  • Brown, S. E., Shah, A., Czuber-Dochan, W., Bench, S., & Stayt, L. (2023). Non-pharmacological interventions for self-management of fatigue in adults: An umbrella review of potential interventions to support patients recovering from critical illness. Journal of critical care, 75, 154279.

    BACKGROUND
  • Alghamdi, A., Alyahya, N., Aldhamri, Y., Alsufyani, M. E., Al-Rawi, M. B. A., & Syed, W. (2025). Online survey of fatigue and associated factors among university students in Riyadh Saudi Arabia. Scientific Reports, 15(1), 35210.

    BACKGROUND
  • Alizadeh, N., Packer, T., Chen, Y.-T., & Alnasery, Y. (2023). What we know about fatigue self-management programs for people living with chronic conditions: A scoping review. Patient Education and Counseling, 114, 107866.

    BACKGROUND
  • Altuntaş, O., & Özkan, E. (2025). Self-management training with online intervention process for young adults with chronic conditions: Effects on self-management, emotion regulation, and occupational balance: A randomized controlled study. Applied Psychology: Health and Well-Being, 17(1), e12644.

    BACKGROUND

MeSH Terms

Conditions

Fatigue Syndrome, ChronicSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesEncephalomyelitisNeuroinflammatory DiseasesNervous System DiseasesNeuromuscular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc. Occupational Therapist, Research Assistant

Study Record Dates

First Submitted

March 2, 2026

First Posted

March 6, 2026

Study Start

September 1, 2024

Primary Completion

October 1, 2024

Study Completion

September 1, 2025

Last Updated

March 6, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations