Trial Outcomes & Findings for Depression and Anxiety in Rheumatoid Arthritis (NCT NCT02122406)

Results Overview

Hospital Anxiety and Depression Scale (HADS) questionnaire. The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains. Patients were defined as having anxiety or depression or both if the score was 8 or more in the corresponding subscale.

Recruitment status

COMPLETED

Target enrollment

200 participants

Primary outcome timeframe

1 day of enrollement

Results posted on

2016-10-10

Participant Flow

Participant milestones

Participant milestones
Measure	Patients RA-BIO Patients with rheumatoid arthritis treated with biological drugs
Overall Study STARTED	200
Overall Study COMPLETED	200
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Depression and Anxiety in Rheumatoid Arthritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients RA-BIO n=200 Participants Patients with rheumatoid arthritis treated with biological drugs
Age, Continuous	62.35 years n=5 Participants
Sex: Female, Male Female	171 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants
Region of Enrollment Italy	200 participants n=5 Participants
Disease Duration	11.24 years n=5 Participants
Disease Activity Score on 28 joints (DAS28)	3.01 units on a scale STANDARD_DEVIATION 1.07 • n=5 Participants

PRIMARY outcome

Timeframe: 1 day of enrollement

Hospital Anxiety and Depression Scale (HADS) questionnaire. The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains. Patients were defined as having anxiety or depression or both if the score was 8 or more in the corresponding subscale.

Outcome measures

Outcome measures
Measure	Patients RA-BIO n=200 Participants Patients with rheumatoid arthritis treated with biological drugs
Hospital Anxiety and Depression Scale (HADS) HEALTHY	107 participants
Hospital Anxiety and Depression Scale (HADS) ANXIETY	46 participants
Hospital Anxiety and Depression Scale (HADS) DEPRESSION	20 participants
Hospital Anxiety and Depression Scale (HADS) ANXIETY/DEPRESSION	27 participants

Adverse Events

Patients RA-BIO

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Vittorio Grosso MD

University of Pavia

Phone: +393332605945

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place