Primer Sjogren's SyndromeNCT06398210
Investigation of the Effectiveness of Cognitive Exercise Therapy Approach in Patients With Primary Sjögren's Syndrome
A study testing Cognitive Exercise Therapy Approach (BETY) in people with Primer Sjogren's Syndrome, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial summary
To determine the effectiveness of the Cognitive Exercise Therapy Approach (BETY in Turkish) in individuals with Primary Sjögren's Syndrome and to compare the effects of this training when applied in groups and individually. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primer Sjogren's Syndrome
- What is being tested?
- Cognitive Exercise Therapy Approach (BETY)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 May 2024to 30 Nov 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with Primary Sjögren's Syndrome
- 18 years or older
Who cannot join
- Patients with Secondary Sjögren's Syndrome,
- Participated in a regular exercise program in the last 2 months,
- Patients who are diagnosed with other uncontrolled/clinically important diseases (chronic obstructive pulmonary disease, congestive heart failure, endocrine system diseases, neurological, psychological diseases, etc.),
- Having a malignant condition,
- Pregnant individuals,
- Have other conditions that prevent exercise,
- Individuals who do not agree to participate in the study and do not give written consent will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
To determine the effectiveness of the Cognitive Exercise Therapy Approach (BETY in Turkish) in individuals with Primary Sjögren's Syndrome and to compare the effects of this training when applied in groups and individually.
H1: BETY training affects at least one of the following: disease activity, pain, and fatigue in individuals with Primary Sjögren's Syndrome.
Read more
H2: BETY training affects at least one of the quality of life and biopsychosocial status in individuals with Primary Sjögren's Syndrome.
H3: BETY training affects the anxiety/depression level in individuals with Primary Sjögren's Syndrome.
H4: BETY training affects chewing and swallowing performances in individuals with Primary Sjögren's Syndrome.
H5: BETY training given in groups is more effective than individual practice in individuals with Primary Sjögren's Syndrome.
Volunteers who meet the inclusion criteria will be placed on the waiting list, the content of all three interventions will be explained to the individuals, and groups will be formed randomly using the sealed envelope method among those who volunteer to participate in all three contents. The three options that will be offered to patients will be 'participation in BETY group sessions', 'participation in individual BETY sessions', and 'following a home program with symptom-oriented exercise recommendations'.
The biopsychosocial-based exercise model ("Cognitive Exercise Therapy Approach" (BETY)) to be used in this randomized controlled study is a method developed on individuals with rheumatic diseases. In this method, which can be applied individually or in a group, nociplastic pain, and mood management are combined with exercises. Patients participating in the training received 36 sessions in total; He/she will attend BETY sessions lasting 1 hour, 3 times a week for 12 weeks, in group and individual sessions. Each session will include a warm-up phase, exercise training, and cool-down phases. During these sessions, the physiotherapist plays only an instructive and guiding role. In BETY sessions, exercises will be made more difficult as the person can perform a higher level exercise, in accordance with the loading principle. An exercise band will be added to the exercises that show a progression from closed kinetic chain to open kinetics, following the developments in the patient.
In the control group, exercise recommendations will be given as a home program according to the individuals' symptoms.
Cognitive Exercise Therapy Approach (BETY) BETY includes mind-body interaction information management, pain management strategies, mood information management through dance therapy/authentic movement, and sexuality information management. BETY first session; After meeting the patient and completing the evaluations, it consists of the steps of analysis of the person's problem, selection of exercise for this problem, replacement of the exercise in function, pain management, and recovery agreement. The basic exercise model used in BETY is function-oriented trunk stabilization exercises. Patients are given information about the 5 features of trunk stabilization (neck, shoulder, rib cage, lumbopelvic region postures and respiratory control), visual imagery, and their control.
BETY-nociplastic pain management strategy includes the following steps;
- Physical activity is stopped when there is pain.
- Due to the relationship between pain and central sensitization, the patient questions whether he or she is worried about something. If there is a situation that causes concern, the patient should direct his/her attention away from this point.
- Cognitive restructuring is achieved with positive thoughts instead of negative thoughts as a distraction strategy.
- At the moment of positive thought, it is recommended to do exercises for the painful area.
Information management in sexuality means that anxiety about sexuality is also a factor that increases pain.
It is added to the sessions with the knowledge that it may be a factor and because it is a subject that cannot usually be talked about. During the "arm openings 1" and "arm openings 2" exercises, during the cognitive restructuring process using positive and negative awareness sentences, is aimed at normalizing these issues in the mind of the individual by including positive and negative sentences about sexuality. In addition, the information will be reinforced by synthesizing the questions asked by the patients during patient education and the pelvic floor muscle training created by trunk stabilization exercises.
- Conditions
- Primer Sjogren's Syndrome
- Being tested
- Cognitive Exercise Therapy Approach (BETY)
- Keywords
- Sjogren' Syndrome, biopsychosocial model, health-related quality of life, patient-reported outcome measure, psychosocial intervention
- Medical subject headings
- Sjogren's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Exercise Therapy Approach (BETY)Other
Cognitive Exercise Therapy Approach (BETY) BETY includes mind-body interaction information management, pain management strategies, mood information management through dance therapy/authentic movement, and sexuality information management. BETY first session; After meeting the patient and completing the evaluations, it consists of the steps of analysis of the person's problem, selection of exercise for this problem, replacement of the exercise in function, pain management, and recovery agreement. The basic exercise model used in BETY is function-oriented trunk stabilization exercises. Patients are given information about the 5 features of trunk stabilization (neck, shoulder, rib cage, lumbopelvic region postures, and respiratory control), visual imagery, and their control.
| Study group | Role | What they receive |
|---|---|---|
| Group exercise | Experimental | Patients will be included in group exercise, 36 sessions in total; He/she will attend BETY-group sessions lasting 1 hour, 3 times a week for 12 weeks. Receives: Other: Cognitive Exercise Therapy Approach (BETY) |
| Individual exercise | Experimental | Patients will be included in individual exercise, 36 sessions in total; He/she will attend BETY-individual sessions lasting 1 hour, 3 times a week for 12 weeks. Receives: Other: Cognitive Exercise Therapy Approach (BETY) |
| Control | No intervention | In the control group, exercise recommendations will be given as a home program according to the symptoms of the individuals. |
What is being measured
The primary outcome is the main question the study is designed to answer.
BETY-Biopsychosocial Questionnaire (BETY-BQ)
BETY-BQ consists of the following six subtitles that investigate in detail the biopsychosocial dimensions: pain, functionality and fatigue, mood, sociability, sexuality, and sleep quality. This scale consists of 30 items, scored on a 5-point Likert system. Each question is scored as "No never: 0 Yes rarely: 1 Yes sometimes: 2 Yes often: 3 Yes always: 4" and a total score over 30 items. A higher score indicates a poorer biopsychosocial situation.
Measured: baseline-12. week-6. month
Secondary outcomes (12)
Central Sensitization Scale
In this scale, which consists of 40 questions and questions the symptoms related to central sensitization, a score above 40 is interpreted as an indicator of central sensitization. Turkish validity and reliability study was conducted.
Measured: baseline-12. week-6. month
Pain Catastrophizing Scale
It is a Likert-type self-assessment scale consisting of 13 items. Each item is scored between 0 and 4 points. The total score ranges from 0 to 52. High scores indicate a high level of catastrophizing. It has 3 subtests: pain magnification (items 6, 7 and 13), rumination (items 8, 9, 10, 11) and helplessness (items 1, 2, 3, 4, 5 and 12). Turkish validity and reliability study was conducted.
Measured: baseline-12. week-6. month
EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI)
ESSDAI is a clinical scale that measures disease activity in Sjögren's Syndrome and its items provide objective data consisting of tests applied to patients during routine outpatient clinic check-ups. An ESSDAI score of less than 4 indicates low activity, a score between 5 and 13 indicates moderate activation, and a score of 14 and above indicates high activity.
Measured: baseline-12. week-6. month
EULAR Sjögren's Syndrome Patient Reporting Index (ESSPRI)
ESSPRI scoring is a symptom severity assessment scale filled out by the patient and used in Sjögren's Syndrome. The patient is asked to express fatigue, pain and dryness complaints with a score between one and ten, and the arithmetic average of the score obtained from these three questions forms the result. An ESSPRI score of less than 5 is considered an acceptable disease state, while a score of 5 or above is considered a sign of high activity.
Measured: baseline-12. week-6. month
Hospital Anxiety and Depression Scale (HADS)
In this scale consisting of fourteen questions, odd-numbered questions question anxiety, and even questions question depression. Options range from 0 to 3, with a higher score indicating a poor emotional state. The cut-off values of the scale were determined as 10 for the anxiety subscale and 7 for the depression subscale. Turkish version study was conducted.
Measured: baseline-12. week-6. month
Primary Sjögren's Syndrome Quality of Life Scale
This scale, consisting of twenty-five questions, is divided into two subsections: physical (discomfort and dryness) and psychosocial. Since vaginal dryness, one of the symptoms of SS, was included in the total score, the maximum score was determined as 96 for women and 92 for men. A high score means low health-related quality of life.
Measured: baseline-12. week-6. month
Multidimensional Fatigue Rating Scale
This scale evaluates fatigue with 16 items under 5 subheadings: degree, severity, impact on daily activities, troubles it causes and fatigue time. The score ranges from 0 (not tired) to 50 (extremely tired). The Turkish validity and reliability study of the scale was conducted.
Measured: baseline-12. week-6. month
Turkish Eating Assessment Tool (T-EAT-10)
T-EAT-10 is a survey consisting of 10 questions with a Likert scale between 0 and 4 (0 = no problem, 4 = severe problem). The total score is calculated out of 40 points by finding the sum of the answers given by individuals to each question. A score of 3 or more in the survey is considered abnormal. A score of 16 or above is considered as suspicion of aspiration. Turkish validity and reliability were tested.
Measured: baseline-12. week-6. month
Yale Swallow Protocol
Yale Swallow Protocol is a reliable screening test performed under expert supervision to determine the risk of aspiration at an early stage. The protocol has three main components. These are exclusion criteria, a short cognitive test, and oral mechanism, and drinking 3 oz (90 cc) water directly from the glass or with a straw. Risk factors are examined in the 1st and 2nd stages to determine the patients to whom the test can be applied. Patients who complete step 1 and are not contraindicated for testing proceed to the short cognitive testing phase. Patients who pass the short cognitive test and oral mechanism stages can proceed to the third stage, which is drinking 90 cc of water. The 90 cc water swallow challenge protocol is a simple assessment that can be used by many qualified healthcare professionals to identify aspiration risk because it is easy to perform, highly reliable, cost-effective, and clinically validated.Patients showing these findings are recorded as 'failing' the test.
Measured: baseline-12. week-6. month
Test of Mastication and Swallowing Solids
In our study, the Test of Mastication and Swallowing Solids (TOMASS) will be used. The test evaluates how many bites the individual takes to eat a biscuit while sitting upright, how many chewing cycles he makes, how many times he swallows it, and how long the total time is from biting to swallowing. Video recording will be taken during the test. The number of bites, number of chewing cycles, number of swallows and total time will be calculated on the video. Individuals will be asked to eat the biscuit normally while sitting on a chair in an upright position with the throat visible. Meanwhile, video recording will be taken from the individuals' front view, showing their mouth and neck. The evaluation of the test will then be made by the evaluator. Videos will be stored in folders on an encrypted computer and only the work team will have access.
Measured: baseline-12. week-6. month
Dysphagia limit
While evaluating dysphagia, individuals are given 5, 10, 15, 20, 25, 30, 35, 40 and 45 mL volumes of liquid, respectively, with a graduated syringe and are asked to swallow the liquid. The maximum amount of fluid that the thyroid cartilage can swallow during a single movement is determined. The normal dysphagia limit in healthy individuals is more than 20 mL. If a person can swallow 20 mL normally, the dysphagia limit is normal.
Measured: baseline-12. week-6. month
Xerostomia inventory
The scale consists of 11 items. Patients will be asked to choose the best response for each item describing their symptoms over the previous two weeks. Responses are scored from 1 to 5 (1: never, 2: rarely, 3: occasionally, 4: fairly often, and 5: very often). The sum of the item scores gives a total score ranging from 11 to 55, and a higher score indicates that the symptoms are more severe. The Turkish validity and reliability study of the scale in individuals with primary Sjögren's Syndrome was conducted.
Measured: baseline-12. week-6. month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start13 May 2024
- Primary completion30 Nov 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primer Sjogren's SyndromeStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single Blinded-Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazli Elif Nacar, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06398210
- Sponsor's protocol ID
- KahramanmarasSIU.
- Status last verified
- Jul 2025
- First submitted
- 30 Apr 2024
- Last updated
- 15 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 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 in Patients With Primary Sjögren's Syndrome
- ClinicalTrials.gov ID
- NCT06398210
- Acronym / sponsor ID
- KahramanmarasSIU.
- Conditions
- Primer Sjogren's Syndrome
- Keywords
- Sjogren' Syndrome, biopsychosocial model, health-related quality of life, patient-reported outcome measure, psychosocial intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 13 May 2024 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 3 May 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.
To determine the effectiveness of the Cognitive Exercise Therapy Approach (BETY in Turkish) in individuals with Primary Sjögren's Syndrome and to compare the effects of this training when applied in groups and individually.
H1: BETY training affects at least one of the following: disease activity, pain, and fatigue in individuals with Primary Sjögren's Syndrome.
H2: BETY training affects at least one of the quality of life and biopsychosocial status in individuals with Primary Sjögren's Syndrome.
H3: BETY training affects the anxiety/depression level in individuals with Primary Sjögren's Syndrome.
H4: BETY training affects chewing and swallowing performances in individuals with Primary Sjögren's Syndrome.
H5: BETY training given in groups is more effective than individual practice in individuals with Primary Sjögren's Syndrome.
Volunteers who meet the inclusion criteria will be placed on the waiting list, the content of all three interventions will be explained to the individuals, and groups will be formed randomly using the sealed envelope method among those who volunteer to participate in all three contents. The three options that will be offered to patients will be 'participation in BETY group sessions', 'participation in individual BETY sessions', and 'following a home program with symptom-oriented exercise recommendations'.
The biopsychosocial-based exercise model ("Cognitive Exercise Therapy Approach" (BETY)) to be used in this randomized controlled study is a method developed on individuals with rheumatic diseases. In this method, which can be applied individually or in a group, nociplastic pain, and mood management are combined with exercises. Patients participating in the training received 36 sessions in total; He/she will attend BETY sessions lasting 1 hour, 3 times a week for 12 weeks, in group and individual sessions. Each session will include a warm-up phase, exercise training, and cool-down phases. During these sessions, the physiotherapist plays only an instructive and guiding role. In BETY sessions, exercises will be made more difficult as the person can perform a higher level exercise, in accordance with the loading principle. An exercise band will be added to the exercises that show a progression from closed kinetic chain to open kinetics, following the developments in the patient.
In the control group, exercise recommendations will be given as a home program according to the individuals' symptoms.
Cognitive Exercise Therapy Approach (BETY) BETY includes mind-body interaction information management, pain management strategies, mood information management through dance therapy/authentic movement, and sexuality information management. BETY first session; After meeting the patient and completing the evaluations, it consists of the steps of analysis of the person's problem, selection of exercise for this problem, replacement of the exercise in function, pain management, and recovery agreement. The basic exercise model used in BETY is function-oriented trunk stabilization exercises. Patients are given information about the 5 features of trunk stabilization (neck, shoulder, rib cage, lumbopelvic region postures and respiratory control), visual imagery, and their control.
BETY-nociplastic pain management strategy includes the following steps;
- Physical activity is stopped when there is pain.
- Due to the relationship between pain and central sensitization, the patient questions whether he or she is worried about something. If there is a situation that causes concern, the patient should direct his/her attention away from this point.
- Cognitive restructuring is achieved with positive thoughts instead of negative thoughts as a distraction strategy.
- At the moment of positive thought, it is recommended to do exercises for the painful area.
Information management in sexuality means that anxiety about sexuality is also a factor that increases pain.
It is added to the sessions with the knowledge that it may be a factor and because it is a subject that cannot usually be talked about. During the "arm openings 1" and "arm openings 2" exercises, during the cognitive restructuring process using positive and negative awareness sentences, is aimed at normalizing these issues in the mind of the individual by including positive and negative sentences about sexuality. In addition, the information will be reinforced by synthesizing the questions asked by the patients during patient education and the pelvic floor muscle training created by trunk stabilization exercises.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Single Blinded-Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Group exercise | Experimental | Other: Cognitive Exercise Therapy Approach (BETY)Patients will be included in group exercise, 36 sessions in total; He/she will attend BETY-group sessions lasting 1 hour, 3 times a week for 12 weeks. |
| Individual exercise | Experimental | Other: Cognitive Exercise Therapy Approach (BETY)Patients will be included in individual exercise, 36 sessions in total; He/she will attend BETY-individual sessions lasting 1 hour, 3 times a week for 12 weeks. |
| Control | No intervention | –In the control group, exercise recommendations will be given as a home program according to the symptoms of the individuals. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients diagnosed with Primary Sjögren's Syndrome
- 18 years or older
Key exclusion criteria (7 listed)
- Patients with Secondary Sjögren's Syndrome,
- Participated in a regular exercise program in the last 2 months,
- Patients who are diagnosed with other uncontrolled/clinically important diseases (chronic obstructive pulmonary disease, congestive heart failure, endocrine system diseases, neurological, psychological diseases, etc.),
- Having a malignant condition,
- Pregnant individuals,
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 |
|---|---|---|
| Cognitive Exercise Therapy Approach (BETY)Cognitive Exercise Therapy Approach (BETY) BETY includes mind-body interaction information management, pain management strategies, mood information management through dance therapy/authentic movement, and sexuality information management. BETY first session; After meeting the patient and completing the evaluations, it consists of the steps of analysis of the person's problem, selection of exercise for this problem, replacement of the exercise in function, pain management, and recovery agreement. The basic exercise model used in BETY is function-oriented trunk stabilization exercises. Patients are given information about the 5 features of trunk stabilization (neck, shoulder, rib cage, lumbopelvic region postures, and respiratory control), visual imagery, and their control. | Other | Group exercise, Individual exercise |
Primary outcome
BETY-Biopsychosocial Questionnaire (BETY-BQ)
Time frame: baseline-12. week-6. month
BETY-BQ consists of the following six subtitles that investigate in detail the biopsychosocial dimensions: pain, functionality and fatigue, mood, sociability, sexuality, and sleep quality. This scale consists of 30 items, scored on a 5-point Likert system. Each question is scored as "No never: 0 Yes rarely: 1 Yes sometimes: 2 Yes often: 3 Yes always: 4" and a total score over 30 items. A higher score indicates a poorer biopsychosocial situation.
12 secondary outcomes
Central Sensitization Scale
Time frame: baseline-12. week-6. month
Pain Catastrophizing Scale
Time frame: baseline-12. week-6. month
EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI)
Time frame: baseline-12. week-6. month
EULAR Sjögren's Syndrome Patient Reporting Index (ESSPRI)
Time frame: baseline-12. week-6. month
Hospital Anxiety and Depression Scale (HADS)
Time frame: baseline-12. week-6. month
Primary Sjögren's Syndrome Quality of Life Scale
Time frame: baseline-12. week-6. month
Multidimensional Fatigue Rating Scale
Time frame: baseline-12. week-6. month
Turkish Eating Assessment Tool (T-EAT-10)
Time frame: baseline-12. week-6. month
Yale Swallow Protocol
Time frame: baseline-12. week-6. month
Test of Mastication and Swallowing Solids
Time frame: baseline-12. week-6. month
Dysphagia limit
Time frame: baseline-12. week-6. month
Xerostomia inventory
Time frame: baseline-12. week-6. month
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 15 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Primer Sjogren's Syndrome
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 Cognitive Exercise Therapy Approach (BETY) in people with Primer Sjogren's Syndrome, run by Kahramanmaras Sutcu Imam 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 2 inclusion and 7 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 15 Dec 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?
BETY-Biopsychosocial Questionnaire (BETY-BQ) (time frame: baseline-12. week-6. month). 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 15 Dec 2025.