Study for Validation of Standardized Questionnaires on Depression and Investigation of the Frequency of Depression in Rheumatoid Arthritis (RA) Participants

Validation of Standardized Questionnaires on Depression for Rheumatoid Arthritis (RA) (VADERA I) and Investigation of the Frequency of Depression in RA (VADERA II)

The purpose of this study is to validate standardized questionnaires on depression for RA and to investigate the frequency of depression with RA. The study will include 2 parts, VADERA I and VADERA II. In VADERA I, 300 participants will be surveyed twice at an interval of 3 months regarding their current emotional condition using standardized questionnaires. On the basis of the results of VADERA I, in VADERA II, the selected questionnaire will be used to assess the prevalence of depression with RA in approximately 1000 participants.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis

Detailed Description

VADERA I is regarded as interventional epidemiologic study. The study was considered as interventional because of the use of the questionnaires and interview for the diagnosis of depression. VADERA II is a cross-sectional epidemiologic study.

• Study Type: Observational
• Enrollment (Actual): 1292

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 14059
  • Dresden, Germany, 01307
  • Erlangen, Germany, 91054
  • Erlangen, Germany, 91056
  • Frankfurt, Germany, 60528
  • Leipzig, Germany, 04103
  • München, Germany, 81541
  • Osnabrück, Germany, 49074
  • Rostock, Germany, 18059
  • Würzburg, Germany, 97080

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

VADERA I was conducted in 9 clinical centers across Germany. VADERA II was conducted in 10 centers representing the spectrum of clinical settings in Germany where participants are diagnosed with rheumatoid arthritis and included large academic medical centers, community hospitals and private rheumatology practices across Germany.

Description

Inclusion Criteria:

• VADERA I: Participants diagnosed with RA, who did not suffer from a concurrent, manifest depressive disorder and had been scheduled for a RA consultation at one of the participating clinics
• VADERA II: All participants diagnosed with RA who were able to complete the questionnaires and had been scheduled for a RA consultation at one of the participating clinics

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
VADERA I; RA participants without a concurrent history of depression and who have not received psychotherapy, antidepressants, or inpatient psychiatric treatment in the 3 months before baseline (T0) will be asked to complete the World Health Organization Five Well-Being Index (WHO-5), Patient Health Questionnaire-9 (PHQ-9) and Beck Depression Inventory (2nd edition) (BDI-II) questionnaires and a subsequent structured interview using Montgomery-Åsberg Depression Rating Scale (MADRS) at 2 time-points (T0 and T1 [12 ± 2 weeks]) with a 10-14 week interval between assessments.
VADERA II; All RA participants who are able to complete the PHQ-9 and BDI-II questionnaires, and have been scheduled for a RA consultation at one of the participating clinics will be eligible for participation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PHQ-9 Score at Baseline: VADERA I	The PHQ-9 is a self-reported questionnaire measuring depressive symptoms.This is a nine item measure with a response score for each item on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day). Thus, the total score ranges from 0 to 27; with 0-4 being minimum indicating no depressive symptoms, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, 20-27 severe depression.	Baseline
PHQ-9 Score at Week 12 ± 2: VADERA I	The PHQ-9 is a self-reported questionnaire measuring depressive symptoms. This is a nine item measure with a response score for each item on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day). Thus, the total score ranges from 0 to 27; with 0-4 being minimum indicating no depressive symptoms, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, 20-27 severe depression.	Week 12 ± 2
BDI-II Score at Baseline: VADERA I	BDI-II Scale is a 21-item self-reported questionnaire which measures the existence and severity of symptoms of depression. Each of the 21 items on BDI-II tool represents a depressive symptom. The symptoms are each scored on a 4-point Likert scale of 0 to 3 (0=symptom is absent; 3=symptom is severe). Scores for each symptom are added up to obtain the total scores for all 21 items. Total score ranges from 0-63; of which 0-8 is considered no depression, 0-13 is minimal depression, 14-19 is mild depression, 20-28 is moderate depression and 29-63 is severe depression.	Baseline
BDI-II Score at Week 12 ± 2: VADERA I	BDI-II Scale is a 21-item self-reported questionnaire which measures the existence and severity of symptoms of depression. Each of the 21 items on BDI-II tool represent a depressive symptom. The symptoms are each scored on a 4-point Likert scale of 0 to 3 (0=symptom is absent; 3=symptom is severe). Scores for each symptom are added up to obtain the total scores for all 21 items. Total score ranges from 0-63; of which 0-8 is considered no depression, 0-13 is minimal depression, 14-19 is mild depression, 20-28 is moderate depression and 29-63 is severe depression.	Week 12 ± 2
WHO-5 Index at Baseline: VADERA I	WHO-5 questionnaire contains five items related to cheerfulness, calmness, feelings of vigor, feelings of being well rested after sleep, and personal interest. The respondent rated each question on a 6-point scale ranging from 0 ("at no time") to 5 ("all of the time") according to the proportion of time over the preceding 2 weeks that applied to the attribute in question. Scores were summated, with raw score ranging from 0 to 25. Then the scores were transformed to 0-100 by multiplying by 4, whereas 0 indicated the worst possible emotional well-being and 100 the best.	Baseline
WHO-5 Index at Week 12 ± 2: VADERA I	WHO-5 questionnaire contains five items related to cheerfulness, calmness, feelings of vigor, feelings of being well rested after sleep, and personal interest. The respondent rated each question on a 6-point scale ranging from 0 ("at no time") to 5 ("all of the time") according to the proportion of time over the preceding 2 weeks that applied to the attribute in question. Scores were summated, with raw score ranging from 0 to 25. Then the scores were transformed to 0-100 by multiplying by 4, whereas 0 indicated the worst possible emotional well-being and 100 the best.	Week 12 ± 2
MADRS at Baseline: VADERA I	The MADRS, an interview addressing 10 characteristics of depressive symptomatology, was used as the gold standard. The symptom-related information provided by each participant was rated on item-specific scales ranging from 0 (best) to 6 (worst) in order to evaluate individual symptom severity. Total score was sum of 10 characteristics, ranging from 0 to 60; 0, no depression; 60, severely depressed. Sum scores exceeding 12 indicated clinical relevance suggested mild to severe symptomatology.	Baseline
MADRS at Week 12 ± 2: VADERA I	The MADRS, an interview addressing 10 characteristics of depressive symptomatology, was used as the gold standard. The symptom-related information provided by each participant was rated on item-specific scales ranging from 0 (best) to 6 (worst) in order to evaluate individual symptom severity. Total score was sum of 10 characteristics, ranging between 0 to 60; 0, no depression; 60, severely depressed. Sum scores exceeding 12 indicated clinical relevance suggested mild to severe symptomatology.	Week 12 ± 2
PHQ-9 Summary Score: VADERA II	The PHQ-9 is a self-reported questionnaire measuring depressive symptoms. This is a nine item measure with a response score for each item on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day). Thus, the total score ranges from 0 to 27; with 0-4 being minimum indicating no depressive symptoms, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, 20-27 severe depression.	Baseline
BDI-II Summary Score: VADERA II	BDI-II Scale is a 21-item self-reported questionnaire which measures the existence and severity of symptoms of depression. Each of the 21 items on BDI-II tool represent a depressive symptom. The symptoms are each scored on a 4-point Likert scale of 0 to 3 (0=symptom is absent; 3=symptom is severe). Scores for each symptom are added up to obtain the total scores for all 21 items. Total score ranges from 0-63; of which 0-8 is considered no depression, 0-13 is minimal depression, 14-19 is mild depression, 20-28 is moderate depression and 29-63 is severe depression.	Baseline
Percentage of Participants With Prevalence of Depressive Symptomatology Based on a BDI-II Score Greater Than or Equal to (≥)14 or PHQ-9 Score ≥5: VADERA II	PHQ-9 is a self-reported questionnaire measuring depressive symptoms. This is a 9-item measure with a response score for each item on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 27; with 0-4 indicating no depressive symptoms, 5-9 mild, 10-14 moderate, 15-19 moderately severe, and 20-27 severe depression. BDI-II Scale is a 21-item self-reported questionnaire measuring existence and severity of depression symptoms. Symptoms are each scored on a 4-point scale of 0 (no symptom) to 3 (severe symptom). Total score ranges from 0-63; of which 0-8 is considered no depression, 0-13 minimal, 14-19 mild, 20-28 moderate, and 29-63 severe depression. Participants with a BDI-II score ≥14 or a PHQ-9 score ≥5 were classified as having depressive symptomatology. Participants were evaluated by positive depressive symptomatology for each questionnaire as well as being positive for both questionnaires combined or at least one of the questionnaires.	Baseline

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Collaborators: Chugai Pharmaceutical

Publications and helpful links

General Publications

• Englbrecht M, Alten R, Aringer M, Baerwald CG, Burkhardt H, Eby N, Flacke JP, Fliedner G, Henkemeier U, Hofmann MW, Kleinert S, Kneitz C, Kruger K, Pohl C, Schett G, Schmalzing M, Tausche AK, Tony HP, Wendler J. New insights into the prevalence of depressive symptoms and depression in rheumatoid arthritis - Implications from the prospective multicenter VADERA II study. PLoS One. 2019 May 28;14(5):e0217412. doi: 10.1371/journal.pone.0217412. eCollection 2019.
• Englbrecht M, Alten R, Aringer M, Baerwald CG, Burkhardt H, Eby N, Fliedner G, Gauger B, Henkemeier U, Hofmann MW, Kleinert S, Kneitz C, Krueger K, Pohl C, Roske AE, Schett G, Schmalzing M, Tausche AK, Peter Tony H, Wendler J. Validation of Standardized Questionnaires Evaluating Symptoms of Depression in Rheumatoid Arthritis Patients: Approaches to Screening for a Frequent Yet Underrated Challenge. Arthritis Care Res (Hoboken). 2017 Jan;69(1):58-66. doi: 10.1002/acr.23002.

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: June 26, 2015
• First Submitted That Met QC Criteria: June 29, 2015
• First Posted (Estimate): June 30, 2015

Study Record Updates

• Last Update Posted (Estimate): October 17, 2016
• Last Update Submitted That Met QC Criteria: August 22, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Depression; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: ML29326