Patients in cancer care being referred for psychological therapy following difficulty with mental health, particularly depression Mental and Behavioural Disorders
Conditions
Interventions
Randomisation is conducted online via REDCap, with data password-protected and accessible only by an unblinded trial coordinator or their nominee. Participants are randomised in a 1:1 ratio to either
Sponsors
Nottinghamshire Healthcare NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or older 2. Able to engage with psychological therapy sessions conducted in English 3. Competent to give informed consent 4. Diagnosed with cancer and awaiting psychological therapy with EMCA CPH for symptoms of moderate-to-severe depression during the recruitment period of the study 5. A score of 10 or more on PHQ-9
Exclusion criteria
Exclusion criteria: 1. Immediate risk to self or others 2. Currently receiving psychological therapy with another service. 3. Unable or unwilling to receive care remotely.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Depression symptoms via the Patient Health Questionnaire 9 (PHQ-9) over 24 weeks with measures at baseline, and then at four, eight, twelve and twenty-four weeks post randomisation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Anxiety is measured using the Generalised Anxiety Disorder 7 (GAD-7) at baseline, 4, 8, 12, and 24 weeks post randomisation 2. Impact of health on daily functioning is measured using the Work and Social Adjustment Scale (WSAS) at baseline, 4, 8, 12, and 24 weeks post randomisation 3. Mental wellbeing is measured using the Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS) at baseline, 4, 8, 12, and 24 weeks post randomisation 4. Participant's knowledge, skills, confidence, and behaviours related to managing their own health and healthcare are measured using the Patient Activation Measure (PAM) at baseline, 4, 8, 12, and 24 weeks post randomisation 5. Participants' willingness or readiness to make a change in their behaviour is measured using the Readiness for Change Ruler at baseline, 4, 8, 12, and 24 weeks post randomisation 6. Health economics and quality of life are measured using the Client Service Receipt Inventory (CSRI) and the Euroqol (EQ5D5L) at baseline and 24 weeks follow up assessment | — |
Countries
England, United Kingdom
Contacts
Public ContactShireen Patel
Outcome results
None listed