SMaRT oncology-2: a two arm parallel group randomised controlled trial to determine the effectiveness and cost-effectiveness of adding a complex intervention for major depressive disorder ('Depression Care for People with Cancer') to usual care, compared to usual care alone in cancer patients

Not Applicable

Completed

• Conditions: Depression in patients with cancer; Mental and Behavioural Disorders; Reaction to severe stress and adjustment disorders

• Registration Number: ISRCTN40568538
• Lead Sponsor: niversity of Edinburgh

Brief Summary

2009 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/19331675 protocol 2014 Results article in http://www.ncbi.nlm.nih.gov/pubmed/25175478 results 2015 Results article in http://www.ncbi.nlm.nih.gov/pubmed/26652589 results

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-05-30
• Study Completion: 2011-06-01
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 500

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified