Depressive symptoms and association with disease activity, pain and disability in juvenile patients with chronic rheumatic diseases
Organizational Data
- DRKS-ID:
- DRKS00016032
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2019-01-10
- Last update in DRKS:
- 2024-01-12
- Registration type:
- Retrospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
Brief summary in lay language
All patients in pediatric rheumatologic care receive a screening for depressive symptoms with the BDI-FS (Beck Depressions-Inventar - Fast Screen for medical patients) at least yearly. Patients with depressive symptoms have the possibility to be psychologically evaluated to ascertain diagnosis of manifest depression. The groups of patient with depressive symptoms / manifest depression will be compared to the patients with a normal BDI-FS score regarding parameters listed in endpoints.
Brief summary in scientific language
All patientd in pediatric rheumatologic care receive a Screening for depressive symptoms with the BDI-FS at least yearly. Patients with depressive symptoms have the possibility to be psychologically evaluated to ascertain diagnosis of manifest Depression. The Groups of Patient with depressive symptoms / manifest Depression will be compared to the patients with a normal BDI-FS score to analyze associations between Depression and Parameters like Age, gender, disease activity, treatment and other Parameters.
Health condition or problem studied
- Free text:
- juvenile idiopathic arthritis
- ICD10:
- M08 - Juvenile arthritis
- Free text:
- other rheumatic diseases
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Patients aged 10-18 years of all genders, who are regularly visiting pediatric rheumatologic care routinely receive a screening for depressive symptoms with the BDI-FS (Beck Depressions-Inventar - Fast Screen for medical patients) at least yearly. Patients with depressive symptoms have the possibility to be psychologically evaluated to ascertain diagnosis of manifest depression. Patient characteristics such as disease activity, therapy, gender, age, disability will be compared between patient with depressive symptoms / manifest depression will and patients with a normal BDI-FS score.
Endpoints
- Primary outcome:
- Prevalence of symptoms of depressive mood and suicidal tendency in juvenile patients with chronic rheumatic disease. Measured by BDI FS (Beck Depressions-Inventar - Fast Screen for medical patients) once yearly in clinical routine. Prevalence of definite depression and suicidality in this patient group.
- Secondary outcome:
- To assess correlations of depressive symptoms and definite depression with o disease activity o diagnosis o pain o disability o age o gender o concomitant disease o therapy
Study Design
- Purpose:
- Other
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- Medical center Kinderrheumazentrum Sankt Augustin
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2018-09-20
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2019-07-01
- Target Sample Size:
- 300
- Final Sample Size:
- 249
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 10 Years
- Maximum Age:
- 18 Years
- Additional Inclusion Criteria:
- diagnosis of chronic rheumatic disease
Exclusion Criteria
none
Addresses
Primary Sponsor
- Address:
- Asklepios Klinik Sankt AugustinZentrum für Kinder-und JugendmedizinProf Dr.med. Gerd HorneffArnold-Janssen-Str.2953757 Sankt AugustinGermany
- Telephone:
- 02241/249-201
- Fax:
- 02241/249-203
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.asklepios.com/sanktaugustin
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Asklepios Klinik Sankt AugustinDr. Ariane KleinArnold-Janssen-Str. 2953757 Sankt AugustinGermany
- Telephone:
- 02241 249496
- Fax:
- 02241 249203
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Asklepios Klinik Sankt AugustinDr. Ariane KleinArnold-Janssen-Str. 2953757 Sankt AugustinGermany
- Telephone:
- 02241 249496
- Fax:
- 02241 249203
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Asklepios Klinik Sankt AugustinDr. Ariane KleinArnold-Janssen-Str. 2953757 Sankt AugustinGermany
- Telephone:
- 02241 249496
- Fax:
- 02241 249203
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Private sponsorship (foundations, study societies, etc.)
- Address:
- Rosemarie-Germscheid StiftungDonaustrasse 1356567 NeuwiedGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Ärztekammer NordrheinTersteegenstr. 940474 DüsseldorfGermany
- Telephone:
- +49-211-43021581
- Fax:
- +49-211-43021585
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2018-08-30
- Ethics committee number:
- No Entry
- Vote of the Ethics Committee:
- No approval required according to the EC
- Date of the vote:
- 2018-09-14
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- Roemer J, Klein A, Horneff G. Prevalence and risk factors of depressive symptoms in children and adolescents with juvenile idiopathic arthritis. Rheumatol Int. 2023 Aug;43(8):1497-1505. doi: 10.1007/s00296-023-05323-4. Epub 2023 Apr 11. PMID: 37039854; PMCID: PMC10261240.
- Date of first publication of study results:
- 2023-04-11
- DRKS entry published for the first time with results:
- 2024-01-12
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- Depression is a serious disorder disproportionately affecting people with chronic diseases, yet, to date is rarely recognized comorbidity in pediatric rheumatology clinical routine care. The aim of this study was to investigate the prevalence of depressive symptoms and depression in children with Juvenile idiopathic arthritis (JIA) and to identify associations to risk factors. Depressive symptoms were assessed using the Beck's Depression Inventory (BDI)-Fast Screen Questionnaire validated for ages 13 and older and confirmed by the BDI or Hamilton Depression Scale. A cross-sectional analysis of 148 patients attending the rheumatology outpatient clinic of the Asklepios Children's Hospital Sankt Augustin between January 2018 and May 2019 was performed. Possible associations between routinely assessed parameters of disease activity and treatment were analysed. 148 JIA patients (71.5% female), median age 14.7 years, were included. The prevalence for depressive symptoms was 13% and for depression 9.5%, of which 71.4% were newly identified with depression. Significant associations with depressive symptoms included rheumatoid factor negative polyarthritis, higher pain scores, functional limitations, higher disease activity, decreased general well-being, higher number of medications taken and not being in remission. In addition, poor treatment response (persistent pain despite therapy) and failure to achieve minimal activity/remission of disease despite intensified therapy with biologics correlated significantly with depressive symptoms. Depressive symptoms are an important comorbidity in JIA. Early recognition and treatment of psychological distress is essential to prevent deterioration in quality of life and long-term prognosis. Consequently, treat-to-target principles should include mental health as a therapeutic goal.