Depression Mental and Behavioural Disorders Affective disorders
Conditions
Interventions
This is a two parallel group randomised controlled trial (RCT) with allocation at the level of the individual. Participants will be randomised to treatment with SSRIs plus Emotional Cognitive Bias Mod
Sponsors
University of Bristol
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 01/12/2022: 1. Aged 18 - 55 years 2. Have a new or first episode of depression (defined as not prescribed an antidepressant in the previous 6 months) 3. Prescribed a course of SSRI medication 4. Score >10 on the PHQ-9 assessment _____ Previous inclusion criteria: 1. Aged 18 - 55 years 2. Have a new or first episode of depression (defined as not prescribed an antidepressant in the previous 6 months) 3. Prescribed a course of sertraline medication 4. Score >10 on the PHQ-9 assessment
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 01/12/2022: 1. Prescribed an antidepressant in the previous 6 months 2. Had a course of high intensity psychological treatment in the last 6 months 3. Alcohol or substance dependency 4. Bipolar disorder, Schizophrenia/Psychosis 5. Dementia 6. Currently under psychiatric care (including those referred but not yet seen) for depression 7. Unable to access online CBM sessions (PC, laptop, phone) 8. Cannot complete questionnaires unaided or would require an interpreter 9. Are taking part in another trial involving a psychological/drug intervention 10. Have a contra indication for fMRI scanning/imaging: 10.1 Significant hearing impairment (aids cannot be worn in the scanner) 10.2 Significant visual impairment that is not corrected by glasses/contact lenses eg, double vision or loss of vision in one eye, severe cataracts 10.3 Metal objects in or around the body which cannot be removed (braces, pacemaker, metal fragments, hearing devices, accidents involving metal fragments) 10.4 History of established central nervous system disease or injury (eg, cerebro-vascular disease, multiple sclerosis, Parkinson’s disease, traumatic brain injury) 10.5 Epilepsy, type 1 diabetes or thermoregulatory problems, including Raynaud's disease 10.6 Location sensitive tattoos to the head, neck, or genital area; (patients exceeding; tattoos covering >5% of the body; longest dimension>20cm; or multiple tattoos 35 kg/m² 10.8 Too physically unwell to tolerate a 30-minute fMRI scan, including musculo-skeletal disorders which make lying supine and still difficult 10.9 Claustrophobia 10.10 Pregnant or trying-to-become pregnant 10.11 We will ask participants not to take recreational drugs for 72 hours prior to each test session and not to drink alcohol for 24 hours prior to each test session _____ Previous exclusion criteria: 1. Prescribed an antidepressant in the previous 6 months 2. Had a course of high intensity psychological treatment in the last 6 months 3. Alcohol or substance dependency 4. Bipolar disorder, Schizophrenia/Psychosis 5. Dementia 6. Currently under psychiatric care (including those referred but not yet seen) for depression 7. Unable to access online CBM sessions (PC, laptop, phone) 8. Cannot complete questionnaires unaided or would require an interpreter 9. Are taking part in another trial involving a psychological/drug intervention 10. Have a contra indication for fMRI scanning/imaging: 10.1 Significant hearing impairment (aids cannot be worn in the scanner) 10.2 Significant visual impairment that is not corrected by glasses/contact lenses eg, double vision or loss of vision in one eye, severe cataracts 10.3 Metal objects in or around the body which cannot be removed (braces, pacemaker, metal fragments, hearing devices, accidents involving metal fragments) 10.4 History of established central nervous system disease or injury (eg, cerebro-vascular disease, multiple sclerosis, Parkinson’s disease, traumatic brain injury) 10.5 Epilepsy, diabetes or thermoregulatory problems, including Raynaud's disease 10.6 Extensive or location-sensitive tattoos, defined as covering >5% of the body; longest dimension> 20cm; multiple tattoos 35 kg/m² 10.8 Too physically unwell to tolerate a 30-minute fMRI scan, including musculo-skeletal disorders which make lying supine and st
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Brain activation in the amygdala in response to happy faces in comparison to rest in the amygdala, assessed by fMRI at 2 week follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Happy versus sad comparisons in the amygdala, happy versus sad and happy versus rest in the medial and dorsolateral prefrontal cortex and occipital cortex, assessed by fMRI at 2 week follow-up 2. Mood assessments, both functional (e.g. quality of life assessments) and depressive and anxious symptoms assessed by questionnaires at 2 and 6 week follow-ups: 2.1. Revised Clinical Interview Schedule (CIS-R) - a detailed psychiatric instrument that will give an ICD10 diagnosis 2.2. Patient Health Questionnaire (PHQ-9) - a brief measure of depressive symptoms 2.3. General Anxiety Disorder questionnaire (GAD-7) - a brief measure of anxiety 2.4. Quality of Life Enjoyment and Satisfaction Questionnaire (QLES) - a brief measure of life enjoyment and satisfaction. 2.5. Snaith-Hamilton Pleasure Scale (SHAPS) - a measure of anhedonia | — |
Countries
England, United Kingdom, Wales
Contacts
Public ContactIan Penton-Voak
Outcome results
None listed