Childhood Rheumatic DiseasesNCT06591949
Cognitive Exercise Therapy Approach (BETY) in JIA
A study testing BETY in people with Childhood Rheumatic Diseases and Juvenile Idiopathic Arthritis (JIA), run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Cognitive Exercise Therapy Approach (*Bilişsel Egzersiz Terapi Yaklaşımı*-BETY), an innovative method developed for adults with rheumatism, aims to promote behavioral change and prevent social isolation by focusing on exercises that provide pain management and functional gains. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Childhood Rheumatic Diseases, Juvenile Idiopathic Arthritis (JIA), Exercise
- What is being tested?
- BETY
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2025to 12 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 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosed with JIA,
- Aged between 7 and 18,
- Individuals who volunteered to participate in the study.
Who cannot join
- Patients with advanced heart/lung/liver/kidney disease, neurologic disease and malignancies,
- Individuals who have undergone major orthopedic surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effectiveness of Cognitive Exercise Therapy Approach (BETY) in Juvenile Idiopathic Arthritis
Cognitive Exercise Therapy Approach (*Bilişsel Egzersiz Terapi Yaklaşımı*-BETY), an innovative method developed for adults with rheumatism, aims to promote behavioral change and prevent social isolation by focusing on exercises that provide pain management and functional gains. BETY also recognizes the importance of family education in achieving these goals. However, there is a need for studies on exercise approaches that fit the biopsychosocial model, such as BETY in childhood rheumatic diseases.
BETY is an innovative exercise approach based on the biopsychosocial model that aims to change the patient's cognitions through exercise, specifically developed for patients with rheumatism. This approach includes function-oriented trunk stabilization exercises, chronic pain management, and authentic dance therapy training targeting positive cognitive displacement. It is carried out in a routinized structure that continues for years on a face-to-face basis in groups and individually.
Interventions that provide physical and psychosocial support are needed in childhood rheumatic diseases. Learning to exercise the muscles surrounding the joints at the proper traction angle through exercise with BETY, gaining the ability to manage chronic pain during the day, gaining positive cognitive displacement skills, and having the opportunity to socialize through both individual and group exercises constitute the basis of the intervention.
- Being tested
- BETY, Control group
- Keywords
- Childhood rheumatic diseases, biopsychosocial model, BETY, Cognitive exercise therapy approach, Exercise
- Medical subject headings
- Arthritis, Juvenile, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BETYOther
The cognitive Exercise Therapy Approach (Bilişsel Egzersiz Terapi Yaklaşımı-BETY) will be applied for 24 one-hour sessions, two days a week.
Control groupOther
Control group will be followed up with a home exercise program, and notes will be taken.
| Study group | Role | What they receive |
|---|---|---|
| BETY session group | Active comparator | JIA patients participating in BETY sessions. Receives: Other: BETY |
| Control Group | Active comparator | JIA patients followed up with a home exercise program. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Juvenile Arthritis Biopsychosocial Questionnaire-JAB-Q-Patient
Developed in 2018 in Turkey, it is a patient/parent-centered measurement method that helps to evaluate the biopsychosocial aspects of the patient, such as disease activity, posture, functional and psychosocial status, fatigue, performance at school. The results obtained from a total of 33 questions are used to evaluate the functional status of children, while their psychosocial status is recorded according to their answers to 21 questions. Scored between 0-164. A high score indicates a poor psychosocial status.
Measured: Three months
Juvenile Arthritis Biopsychosocial Questionnaire-JAB-Q-Family
JAB-Q is used to assess the biopsychosocial status of patients and their parents. JAB-Q is a multidimensional questionnaire with a parent (family) form. The questionnaire developed in Turkish is completed by one of the parents/persons responsible for the child. The family form assesses the biopsychosocial status of the parent from their perspective and scores between 0 and 38. Higher scores indicate worse biopsychosocial status.
Measured: Three months
Secondary outcomes (4)
Pain Catastrophizing Scale - Parent Version (PCS-P)
It is assessed with a 5-point Likert scale ranging from 0 (never) to 4 (always) and consists of 13 items. Parallel to the child questionnaire, it assesses three domains: rumination, magnification, and helplessness. A total score between 0-52 is obtained; higher scores reflect a higher level of catastrophizing in parents.
Measured: Three months
Child and Adolescent Scale of Participation (CASP):
It is a 20-question questionnaire that evaluates the community participation of children and adolescents in school, neighborhood, and close environments. The questionnaire includes four sub-sections: 6 questions about home participation, four about neighborhood and community participation, five about school participation, and five about home and community participation. The questionnaire rating is expected by age (full participation), somewhat limited, very limited, not applicable, and not applicable. The family of the child or primary carer completes the questionnaire. The person completing the questionnaire is asked to select the answer that best describes the participation of a child in their care. As a result, the assessment is based between 0-100 points, with higher scores describing a better level of involvement.
Measured: Three months
Childhood Health Assessment Questionnaire (CHAQ)
The CHAQ assesses the functional abilities of children with JIA in activities of daily living. It consists of eight subsections (dressing and personal care, standing up, eating, walking, body care, reaching, holding, and activities). It also assesses pain and general well-being with a visual analog scale. Scores range between 0 and 3 points. A high score is an indicator of low functionality.
Measured: Three months
Pain Catastrophising Scale-Child (PPS-C)
It consists of 13 items describing different thoughts and feelings that children may experience when they feel pain. The questionnaire measures three areas: rumination, magnification, and helplessness. All items are evaluated on a 5-point Likert scale ranging from 0 (never) to 4 (always). Higher scores indicate more catastrophic pain beliefs. The total score is scored between 0 and 52.
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start15 Jan 2025
- Primary completion15 Jun 2025
- Study completion12 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood Rheumatic DiseasesStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Orkun Tüfekçi, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06591949
- Sponsor's protocol ID
- SBA 24/1113
- Status last verified
- Sep 2025
- First submitted
- 9 Sep 2024
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Will not be shared to protect the data of individuals
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Cognitive Exercise Therapy Approach (BETY) in Juvenile Idiopathic Arthritis
- ClinicalTrials.gov ID
- NCT06591949
- Acronym / sponsor ID
- SBA 24/1113
- Keywords
- Childhood rheumatic diseases, biopsychosocial model, BETY, Cognitive exercise therapy approach, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 12 Sep 2025 (actual)
- First posted
- 19 Sep 2024 (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.
Cognitive Exercise Therapy Approach (*Bilişsel Egzersiz Terapi Yaklaşımı*-BETY), an innovative method developed for adults with rheumatism, aims to promote behavioral change and prevent social isolation by focusing on exercises that provide pain management and functional gains. BETY also recognizes the importance of family education in achieving these goals. However, there is a need for studies on exercise approaches that fit the biopsychosocial model, such as BETY in childhood rheumatic diseases.
BETY is an innovative exercise approach based on the biopsychosocial model that aims to change the patient's cognitions through exercise, specifically developed for patients with rheumatism. This approach includes function-oriented trunk stabilization exercises, chronic pain management, and authentic dance therapy training targeting positive cognitive displacement. It is carried out in a routinized structure that continues for years on a face-to-face basis in groups and individually.
Interventions that provide physical and psychosocial support are needed in childhood rheumatic diseases. Learning to exercise the muscles surrounding the joints at the proper traction angle through exercise with BETY, gaining the ability to manage chronic pain during the day, gaining positive cognitive displacement skills, and having the opportunity to socialize through both individual and group exercises constitute the basis of the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BETY session group | Active comparator | Other: BETYJIA patients participating in BETY sessions. |
| Control Group | Active comparator | Other: Control groupJIA patients followed up with a home exercise program. |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Diagnosed with JIA,
- Aged between 7 and 18,
- Individuals who volunteered to participate in the study.
Key exclusion criteria (2 listed)
- Patients with advanced heart/lung/liver/kidney disease, neurologic disease and malignancies,
- Individuals who have undergone major orthopedic surgery.
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 |
|---|---|---|
| BETYThe cognitive Exercise Therapy Approach (Bilişsel Egzersiz Terapi Yaklaşımı-BETY) will be applied for 24 one-hour sessions, two days a week. | Other | BETY session group |
| Control groupControl group will be followed up with a home exercise program, and notes will be taken. | Other | Control Group |
Primary outcome
Juvenile Arthritis Biopsychosocial Questionnaire-JAB-Q-Patient
Time frame: Three months
Developed in 2018 in Turkey, it is a patient/parent-centered measurement method that helps to evaluate the biopsychosocial aspects of the patient, such as disease activity, posture, functional and psychosocial status, fatigue, performance at school. The results obtained from a total of 33 questions are used to evaluate the functional status of children, while their psychosocial status is recorded according to their answers to 21 questions. Scored between 0-164. A high score indicates a poor psychosocial status.
Juvenile Arthritis Biopsychosocial Questionnaire-JAB-Q-Family
Time frame: Three months
JAB-Q is used to assess the biopsychosocial status of patients and their parents. JAB-Q is a multidimensional questionnaire with a parent (family) form. The questionnaire developed in Turkish is completed by one of the parents/persons responsible for the child. The family form assesses the biopsychosocial status of the parent from their perspective and scores between 0 and 38. Higher scores indicate worse biopsychosocial status.
4 secondary outcomes
Pain Catastrophizing Scale - Parent Version (PCS-P)
Time frame: Three months
Child and Adolescent Scale of Participation (CASP):
Time frame: Three months
Childhood Health Assessment Questionnaire (CHAQ)
Time frame: Three months
Pain Catastrophising Scale-Child (PPS-C)
Time frame: Three months
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 18 Sep 2025.
- Individual participant dataSharing planned: No. Will not be shared to protect the data of individuals
Related trials for Childhood Rheumatic Diseases
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Compassionate Care and Organization of Healthcare Services for a Successful Transition in Rheumatology
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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 BETY in people with Childhood Rheumatic Diseases and Juvenile Idiopathic Arthritis (JIA), 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 3 inclusion and 2 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 18 Sep 2025. 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?
Juvenile Arthritis Biopsychosocial Questionnaire-JAB-Q-Patient (time frame: Three months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Sep 2025; AzTrials last refreshed its copy on 30 Oct 2026.