Patient-reported outcome measures (PROMs) in the assessment and follow-up monitoring of patients with depression in primary care

Not Applicable

Completed

Conditions: Topic: Mental Health, Primary Care
Subtopic: Depression, Mental Health, Primary care
Disease: Depression, All Diseases
Mental and Behavioural Disorders

Registration Number: ISRCTN97492541

Lead Sponsor: niversity of Southampton (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 48

Inclusion Criteria

Adults who are diagnosed with depression by their GPs

Exclusion Criteria

1. Patients with comorbid dementia, psychosis, or significant substance misuse, of a level that makes depression a secondary rather than primary diagnosis
2. Patients who are seriously suicidal and need urgent referral to secondary care

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcomes as of 15/12/2016:<br>1. Depressive symptoms are measured using the Beck Depression Inventory (BDI)-II at baseline, 12 weeks, and 26 weeks<br>2. Health-related quality of life is measured using the EuroQoL five-dimension scale (EQ-5D-DL) at baseline, 12 weeks, and 26 weeks<br>3. Social functioning is measured using the Work and Social Adjustment Scale (WSAS) at baseline, 12 weeks, and 26 weeks<br><br>Original primary outcome:<br>Beck Depression Inventory (BDI)-II; Timepoint(s): 12 weeks and 26 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes as of 15/12/2016:<br>1. Anxiety symptoms are measured using the GAD-7 screening questionnaire at baseline<br>2. Participant characteristic data is assessed using a bespoke demographic questionnaire at baseline<br>3. Previous history and treatment received by participant is assessed using a bespoke duration and past history of depression questionnaire at baseline<br>4. Details of use of health services by participant is assessed using a bespoke Client Services Receipt Inventory (CSRI) questionnaire at 26 weeks<br>5. Absence from work by participant is assessed using a bespoke Sickness Absence Questionnaire at 26 weeks<br>6. Satisfaction with GP consultations for depression is assessed using the Medical Informant Satisfaction Scale (MISS) at 26 weeks<br><br><br>Original secondary outcome:<br>1. EQ-5D; Timepoint(s): 12 weeks and 26 weeks<br>2. Short Form (SF)-12; Timepoint(s): 12 weeks and 26 weeks<br>3. Work and Social Adjustment Scale (WSAS); Timepoint(s): 12 weeks and 26 weeks