Sub-clinical depression Mental and Behavioural Disorders Depressive episode
Conditions
Interventions
Active intervention:
Low intensity form of collaborative care delivered by a case manager of 6 - 8 weekly sessions. Collaborative care is the most effective and efficient way of organi
Sponsors
University of York (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria as of 10/03/2016: 1. Age = 75 years during the pilot phase or = 65 years during the main trial 2. Identified by a GP practice as being able to take part in collaborative care Original inclusion criteria: Elderly people (aged 75 years and older, either sex) with screen-positive depression on the Quality Outcomes Framework Depression 1 (QOF DEP1) - compliant 'two depression screening questions', but do not reach the threshold for International Classification of Disease, version 10 (ICD 10) moderate depressive disorder
Exclusion criteria
Exclusion criteria: Exclusion criteria as of 10/03/2016: Those identified by a primary care clinician as: 1. Having a known alcohol dependency (as recorded on GP records) 2. Experiencing psychotic symptoms (as recorded on GP records) 3. Having any known comorbidity that would, in the GP’s opinion, make entry to the trial inadvisable (e.g. recent evidence of suicidal risk/self-harm, significant cognitive impairment) 4. Being affected by other factors that would make an invitation to participate in the trial inappropriate (e.g. recent bereavement, terminal malignancy) Original exclusion criteria: 1. Reached threshold for ICD 10 moderate depressive disorder 2. Patients with alcohol dependence 3. Patients with dementia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Self reported depression severity (as measured by the 9-item Patient Health Questionnaire [PHQ-9]) at 4 months as a continuous measure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Updated secondary outcome measures: Note: The secondary outcome measures were updated to the following prior to recruitment of the first participant into the study. 1. Depression severity and symptomatology is measured using the 9-item Patient Health Questionnaire (PHQ-9) at baseline and 12 months 2. Binary depression severity at 4 and 12 months is measured using the 9-item Patient Health Questionnaire (PHQ-9) using scores = 10 to designate moderate depression caseness at 4 and 12 months 3. Health state utility is measured using European Quality of Life-5 Dimensions (EQ-5D) at 4 and 12 months 4. Physical health and somatic complaints is measured using a 15-item scale using Patient Health Questionnaire-15 items (PHQ-15) at baseline, 4 and 12 months 5. Quality of life is measured using Short Form questionnaire-12 items (SF-12) and EQ-5D at baseline, 4 and 12 months 6. Psychological anxiety is measured using the Generalized Anxiety Disorder 7-item (GAD-7) scale at baseline, 4 and 12 months 7. Resilience and the ability to bounce back is measured using the Connor–Davidson Resilience Scale two-item version (CD-RISC 2) at baseline, 4 and 12 months 8. Self-report medication data at baseline, 4 and 12 months (Not applicable to participants who fully withdraw from the study) 9. Healthcare resource use data obtained from GP practices measures: 9.1. Participants’ contacts with GPs (appointments, home visits or telephone consultations) 9.2. Participants’ contacts with practice nurses (appointments or telephone consultations) 9.3. Prescriptions across each participant's follow up period of 12 months (or up until they leave the practice/die) 10. Mortality across the follow up period is measured using a data linkage service established with the Health and Socia | — |
Countries
United Kingdom
Outcome results
None listed