Recurrent depressive disorder Mental and Behavioural Disorders
Conditions
Interventions
Randomisation will be performed by an independent statistician from the Pragmatic Clinical Trials Unit (PCTU) who is not part of the trial team. The feasibility trial will be cluster randomised, with
Sponsors
East London NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. 18-80 years old 2. Clinical diagnosis of depression with a duration of illness of at least 2 years 3. Using NHS mental health services for the treatment of depression with regular contact with clinicians 4. Capacity to provide informed consent 5. Ability to speak and understand English 6. Low quality of life (as indicated by a score of =10 on the MADRS)
Exclusion criteria
Exclusion criteria: Patients: 1. Does not meet inclusion criteria 2. A mean score of 5 or more on the MANSA 3. A total score of less than 10 on the MADRS 4. Primary problem of current substance misuse 5. No capacity to provide informed consent 6. An inpatient on a psychiatric ward at the time of recruitment Clinicians: 1. Does not meet inclusion criteria 2. Does not have any clinical contact with patients with depression
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of life, measured using the Manchester Short Assessment of Quality of Life (MANSA) at baseline and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured at baseline and 6 months: 1. Depression symptoms, measured by two scales, the Montgomery–Samberg Depression Rating Scale (MADRS; observer rated) and Beck Depression Inventory (BDI-II; self-report) 2. General mental health symptoms, observer rated by the Health of the Nation Outcome Scale (Honos) 3. Physical health satisfaction, measured by the SF-36 4. Economic evaluation through completion of the ICECAP-A (a measure of capability for the general adult population) 5. Satisfaction with care, measured using the Client Satisfaction Questionnaire (CSQ-8) 6. Health-related quality of life, measured using the Europol 5 dimension (EQ-5D-35L) 7. Social functioning, observer rated on the Global Assessment of Functioning (GAF) 8. Data on health service usage in the past 6 months by the participant, collected via an amended version of the Client Service Receipt Inventory (CSRI) 9. The experience of receiving the DIALOG+ intervention, assessed using a bespoke questionnaire developed in partnership with the TACK Lived Experience Advisory Panel (only participants allocated to the intervention arm will complete this) at 6 month follow up | — |
Countries
England, United Kingdom
Outcome results
None listed