Depression in patients with cancer Mental and Behavioural Disorders Reaction to severe stress and adjustment disorders
Conditions
Interventions
Patients will be randomised to receive:
1. Usual care, or
2. Usual care plus 'Depression Care for People with Cancer'
Usual care arm:
T
Sponsors
University of Edinburgh
NHS Lothian - University Hospitals Division (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must: 1. Have a diagnosis of cancer, with active disease within the last five years 2. Be aged 18 or over, either sex 3. Be attending a specialist oncology clinic 4. Have a predicted survival, estimated by their cancer specialist, of twelve months or more 5. Have symptoms that meet Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) criteria for major depressive disorder (MDD), with symptoms of the current major depressive episode (MDE) present for four weeks or more using the inclusive approach to diagnosis
Exclusion criteria
Exclusion criteria: 1. Patients are unable to provide informed consent to participate 2. The episode of depression is chronic (defined as a history of continuous depression for at least two years) 3. They are judged to require urgent psychiatric care 4. They are receiving active psychiatric or psychological treatment from specialist mental health services 5. They have cognitive impairment or communication difficulties (including inability to adequately understand verbal explanations or written information in English) which are incompatible with the intervention 6. They have known cerebral metastases 7. They are unable to attend regularly for treatment sessions 8. The intervention is judged to be inappropriate due to a medical condition which requires alternative treatment 9. The intervention is judged to be inappropriate due to a psychiatric condition which requires alternative treatment (psychotic illness, bipolar affective disorder, obsessive compulsive disorder, substance abuse or dependence) 10. Their participation in the trial is judged to be inappropriate on other clinical grounds N.B. Patients receiving active cancer treatments will not be excluded unless they fulfil one or more of the exclusion criteria listed above.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment response, measured at 24 week outcome data collection, defined as a reduction of 50% or more in the patient?s baseline SCL-20D score | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Remission of major depressive disorder, defined as an SCL-20D score of less than 0.75 at each of 24, 36 and 48 weeks (higher than in primary care trials, to allow for cancer-related somatic symptoms) 2. Depression severity, defined for each patient as the average of their SCL-20D score at 24, 36 and 48 weeks | — |
Countries
Scotland, United Kingdom
Outcome results
None listed