Fatigue Syndrome, ChronicNCT07455123
The Effect of a Self-Management Program in University Students
A study testing Self-Management Programme for Chronic Fatigue in people with Fatigue Syndrome, Chronic, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fatigue Syndrome, Chronic
- What is being tested?
- Self-Management Programme for Chronic Fatigue
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2024to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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:
- 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.
- Conditions
- Fatigue Syndrome, Chronic
- Being tested
- Self-Management Programme for Chronic Fatigue
- Keywords
- Chronic fatigue, self-management, occupational balance, psychological resilience, quality of sleep
- Medical subject headings
- Fatigue Syndrome, Chronic, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Management Programme for Chronic FatigueBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Self-Management Programme for Chronic Fatigue |
| Control - Information Session | No intervention | No intervention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start1 Sep 2024
- Primary completion1 Oct 2024
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Fatigue Syndrome, ChronicStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Medine Nur Özata Değerli, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07455123
- Sponsor's protocol ID
- E-68552689-000-00003545299
- Status last verified
- Mar 2026
- First submitted
- 2 Mar 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Holmefur M, Roshanay A, White S, Janeslatt G, Vimefall E, Lidstrom-Holmqvist K. Evaluation of the "Let's Get Organized" group intervention to improve time management: protocol for a multi-centre randomised controlled trial. Trials. 2021 Sep 19;22(1):640. doi: 10.1186/s13063-021-05578-x.
PubMed 34538253Brown SE, Shah A, Czuber-Dochan W, Bench S, Stayt L. Non-pharmacological interventions for self-management of fatigue in adults: An umbrella review of potential interventions to support patients recovering from critical illness. J Crit Care. 2023 Jun;75:154279. doi: 10.1016/j.jcrc.2023.154279. Epub 2023 Feb 23.
PubMed 36828754Alghamdi A, Alyahya N, Aldhamri Y, Alsufyani ME, Al-Rawi MBA, Syed W. Online survey of fatigue and associated factors among university students in Riyadh Saudi Arabia. Sci Rep. 2025 Oct 8;15(1):35210. doi: 10.1038/s41598-025-21390-y.
PubMed 41062797Alizadeh N, Packer T, Chen YT, Alnasery Y. What we know about fatigue self-management programs for people living with chronic conditions: A scoping review. Patient Educ Couns. 2023 Sep;114:107866. doi: 10.1016/j.pec.2023.107866. Epub 2023 Jun 22.
PubMed 37364380Altuntaş, 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07455123
- Acronym / sponsor ID
- E-68552689-000-00003545299
- Conditions
- Fatigue Syndrome, Chronic
- Keywords
- Chronic fatigue, self-management, occupational balance, psychological resilience, quality of sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 6 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-Management Programme (SMP) | Experimental | Behavioral: Self-Management Programme for Chronic FatigueParticipants 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. |
| Control - Information Session | No intervention | –No intervention group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-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. | Behavioural | Self-Management Programme (SMP) |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Background: PubMed 34538253Holmefur M, Roshanay A, White S, Janeslatt G, Vimefall E, Lidstrom-Holmqvist K. Evaluation of the "Let's Get Organized" group intervention to improve time management: protocol for a multi-centre randomised controlled trial. Trials. 2021 Sep 19;22(1):640. doi: 10.1186/s13063-021-05578-x.
- Background: PubMed 36828754Brown SE, Shah A, Czuber-Dochan W, Bench S, Stayt L. Non-pharmacological interventions for self-management of fatigue in adults: An umbrella review of potential interventions to support patients recovering from critical illness. J Crit Care. 2023 Jun;75:154279. doi: 10.1016/j.jcrc.2023.154279. Epub 2023 Feb 23.
- Background: PubMed 41062797Alghamdi A, Alyahya N, Aldhamri Y, Alsufyani ME, Al-Rawi MBA, Syed W. Online survey of fatigue and associated factors among university students in Riyadh Saudi Arabia. Sci Rep. 2025 Oct 8;15(1):35210. doi: 10.1038/s41598-025-21390-y.
- Background: PubMed 37364380Alizadeh N, Packer T, Chen YT, Alnasery Y. What we know about fatigue self-management programs for people living with chronic conditions: A scoping review. Patient Educ Couns. 2023 Sep;114:107866. doi: 10.1016/j.pec.2023.107866. Epub 2023 Jun 22.
- BackgroundAltuntaş, 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Management Programme for Chronic Fatigue in people with Fatigue Syndrome, Chronic, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fatigue Severity (Piper Fatigue Scale Total Score) (time frame: Baseline and Week 12). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07455123, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.