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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN97492541

Enrollment

Registered

2014-08-21

Start date

2014-10-01

Completion date

Unknown

Last updated

2017-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Mental Health, Primary Care

Interventions

Eight practices will be randomised: four cluster-randomised practices and four practices with individually randomised patients. Two practices within the cluster-randomised arm will be intervention pra

PSYCHLOPS

Distress Thermometer

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adults who are diagnosed with depression by their GPs

Exclusion criteria

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

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

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

Measure

Time frame

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

—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026