Depression Mental and Behavioural Disorders Depressive episode
Conditions
Interventions
Intervention group:
UK-specific collaborative care protocol developed from our Trial Platform delivered via scheduled telephone and face-to-face contacts by a supervised case manager over four months
Sponsors
University of Exeter (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: We will include patients (both males and females) meeting the diagnostic criteria for depression who are aged 18 years and above and who are not currently receiving treatment for depression from specialist mental health services. We will establish the diagnosis of depression by the use of the Clinical Interview Schedule (CIS-R) undertaken by a research worker. We wish our trial to reflect the real world as closely as possible by including all patients with depression; we will therefore include both patients newly identified as depressed, with or without one or more previous depressive episodes, and those with a current depressive illness which has not responded to primary care management in the previous four months. We will also include patients who are suffering from peri- or post-natal depression, with either co-morbid physical illness or co-morbid non-psychotic functional disorders, such as anxiety. In line with the pragmatic nature of this trial, we will reflect usual GP care and participants will be eligible to participate whether they are in receipt of antidepressant medication or not.
Exclusion criteria
Exclusion criteria: 1. Patients whose risk of suicide is sufficiently acute to demand immediate management by a crisis team. Case managers will be trained to recognise and manage less acute risk through applying the procedures taught in the STORM (Skills-based Training On Risk Management) training, we will follow the trial suicide protocol. We will ensure that the patient's GP is involved immediately so they can take appropriate action for patients with suicidal plans. 2. Psychotic patients 3. Patients where the low mood is better explained by a simple bereavement reaction 4. Patients whose primary presenting problem is alcohol or drug abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Self-report severity of depression at 4 and 12 months follow-up, assessed using the Patient Health Questionnaire-9 (PHQ9). The PHQ9 is a self-report measure and therefore less subject to observer bias. It is sensitive to change with good psychometric properties and we have recently validated its sensitivity and specificity for a UK population. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following outcome measures except CSQ-8 will be taken at baseline, 4 and 12 months follow-up: 1. Diagnosis of depression assessed by Clinical Interview Schedule (CIS-R), a computerised interview, and the Beck Depression Inventory II (BDI-II) 2. Health related quality of life, assessed by the SF-36 Health Survey 3. Health care utilisation, measured using case records and a patient service utilisation questionnaire 4. Health state utilities, assessed by EuroQoL 5. Satisfaction with care, measured by the Client Satisfaction Questionnaire (CSQ-8) at 4 months 6. Economic analysis. The incremental cost per Quality-Adjusted Life Years (QALY) of the intervention compared to the control will be calculated from NHS and Personal Social Services (PSS) perspectives. Process data will be collected within the trial. The extensive quantitative and qualitative work in our pilot trial has indicated that the planned intervention is effective and acceptable, and our process evaluation in the main trial will focus on: 1. The process of implementation of the intervention, and 2. Mechanisms of change and differential response in patient subgroups Investigation of the process of implementation will involve qualitative interviews with patients, GPs, case managers and specialist professionals, augmented with routinely collected data on from case records and session audio-tapes. Key stakeholders including GPs, patients, case managers and supervisors will be purposively sampled to represent a range and diversity of views and experiences. We will conduct between 30 - 40 interviews with these stakeholders until theoretical saturation has been achieved. All interviews will be audio-taped and transcribed verbatim. The analysis will examine the implementation of collaborative care, with a focus on differences between sites and different case managers. Investigation of mechanisms of change and differential response in patient subgroups will include quantitative measurement of key patien | — |
Countries
United Kingdom
Outcome results
None listed