Treatment of major depressive disorder Mental and Behavioural Disorders
Conditions
Interventions
This is a single-blind (assessors blinded for observer-rated outcomes), controlled feasibility randomisation trial. Our Clinical Trials Unit will use minimisation for baseline Maudsley Staging Model t
Sponsors
King's College London
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Age =18 years 2. PHQ-9 score=10 (i.e. “caseness” definition in NHS psychological treatment services) 3. Diagnosis of MDD on SCID-I for DSM-5 4. Able to understand written materials, this is essential for the scientific quality of the study, because this intervention is text-based in large parts, which at this stage of the research we are only able to provide in English with translations into other languages planned should our project be successful and allow us to obtain further funding
Exclusion criteria
Exclusion criteria: 1. Previously tried computerised CBT 2. High suicide risk (MINI suicidality screen) 3. Current self-harm with injuries within the last 6 months (self-report) 4. Medication changed in the last 6 weeks including dose changes (self-report) 5. Ongoing psychotherapy (self-report) 6. Past violence in the last 6 months (self-report) 7. Current aggression (screening or pre-screening assessments) 8. Current psychotic symptoms (screening or pre-screening assessments) 9. History of schizophreniform symptoms (screening or pre-screening assessments using validated screening questions) 10. Bipolar disorder including otherwise specified (structured interview for DSM-5 or pre-screening assessment) 11. Current mixed episode (structured interview for DSM-5) 12. No personal smartphone or tablet with internet access
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acceptability measured by loss-to-follow-up rates | — |
Secondary
| Measure | Time frame |
|---|---|
| Standardised follow-up assessments 10–11 weeks after the baseline visit will assess trial outcomes: 1. Adherence is measured using app engagement data automatically recorded in the app and a self-report questionnaire at follow-up. 2. Acceptability of the web-based app is also measured using the Technology Acceptance Model – Fast Form (TAM-FF) at follow-up. 3. Acceptability of the treatment programme is further measured using the Satisfaction with Therapy subscale (Oei & Green, 2008) at follow-up. 4. Costs are measured using a service use questionnaire developed at the IoPPN and follow-up. 5. Quality of life is measured using the EQ-5D-5L at baseline and follow-up. 6. Adverse event rates are measured using clinical monitoring and adverse event reporting forms at follow-up. 7. Recruitment rate is measured using trial screening logs monthly after baseline assessment. The following clinical measures will be used for characterising participants and their symptoms prior and after the intervention, but not as outcome measures per se. Standard deviation estimates for computing effect size estimates on symptom measures to inform sample size calculations for larger subsequent trials will be derived from measures of depressive symptoms: 8. Depressive symptoms are measured using the Montgomery-Åsberg Depression Rating Scale (MADRS) at baseline and final visit. This could be used as the primary outcome in our future definitive trial. 9. Global clinical change is measured using the Clinical Global Impression change scale rated by participant and blinded observer at final visit. 10. Anxiety symptoms are measured using the Generalised Anxiety Disorder – 7 (GAD-7) scale at baseline and final visit. 11. Depressive symptoms are also measured using the Maudsley Modified PHQ-9 (MM-PHQ-9) at baseline and follow-up. 12. Self-esteem is measured using the Rosenberg Self-Esteem Scale at baseline and follow-up. 13. Self-blame is measured using the moral emotion addend | — |
Countries
England, United Kingdom
Contacts
Public ContactRoland Zahn
Outcome results
None listed