Depression Mental and Behavioural Disorders Affective disorders
Conditions
Interventions
Eligible participants will be randomised to one of two treatment arms
either a course of individual integrated CBT (9 sessions of therapist-led CBT, with (up to) a further 3 sessions if deemed clinically appropriate), or usual care, which may include referral to local p
Beck 1995). Participants who are randomised to receive the therapy will receive login details to the platform before the first session to enable them to familiarise themselves with the platform. They
Sponsors
University of Bristol
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Aged >=18 years 2. Score >= 14 on Beck Depression Inventory (BDI-II) 3. Meet ICD-10 criteria for depression
Exclusion criteria
Exclusion criteria: 1. Alcohol or substance dependency in the past year 2. Bipolar disorder 3. Schizophrenia/Psychosis 4. Dementia 5. Currently under psychiatric care (including those referred but not yet seen) for depression 6. Cannot complete questionnaires unaided or would require an interpreter 7. Are currently receiving CBT or other psychotherapy 8. Have received high-intensity CBT in past 4 years 9. Are taking part in another intervention trial 10. Not willing or able to receive CBT via computer/laptop/smartphone
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Depression using the Beck Depression Inventory (BDI-II) score (measured as a continuous variable) at 6 months post-randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Depressive symptoms (BDI-II) at 6 months post-randomisation, used to measure: treatment response (at least 50% reduction in depressive symptoms on the BDI-II compared with baseline); remission of symptoms (BDI-II<10); and percentage reduction in depressive symptoms 2. Depressive symptoms on PHQ-9 at 6-months post-randomisation 3. Quality of life using WSAS and EQ-5D-5 at 6-months post-randomisation 4. Anxiety symptoms (GAD-7) at 6-months post-randomisation 5. All the above outcome measures at 12 months post-randomisation 6. Economic evaluation: 6.1. EQ-5D-5L (measured at 0, 6 and 12 months post-randomisation) 6.2. Number of primary care consultations and prescribed medications (from GP practice medical records over 12 months) 6.3. Use of other primary and community care services; secondary care related to mental health; private treatments; use of social services; burden on informal caregivers; personal costs related to mental health; and benefits received (collected by questionnaire at 6 and 12 months post-randomisation) | — |
Countries
England, United Kingdom
Outcome results
None listed