SMaRT Oncology-3: a two-arm parallel group randomised controlled trial to determine the efficacy of adding a complex intervention for major depressive disorder (Depression Care for People with Lung Cancer) to usual care, compared to usual care alone in patients with lung cancer

Not Applicable

Completed

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

• Registration Number: ISRCTN75905964
• Lead Sponsor: niversity of Edinburgh (UK)

Brief Summary

2009 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/19793390 protocol 2014 Results article in http://www.ncbi.nlm.nih.gov/pubmed/25175097 results

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-11-28
• Study Completion: 2011-07-01
• Last Update Posted: 7 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 142

Inclusion Criteria

1. Both males and females, aged 18 or over
2. Have a diagnosis of lung cancer
3. Have a predicted survival, estimated by their cancer specialist, of three months or more
4. Have symptoms which meet the 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. 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. Judged to require urgent psychiatric care
4. Receiving active psychiatric or psychological treatment from specialist mental health services
5. Cognitive impairment or communication difficulties (including inability to adequately understand verbal explanations or written information in English) which are incompatible with the intervention
6. Known cerebral metastases
7. Unable to participate regularly in 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. 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