MILESTONE (Emotional Cognitive Bias Modification in Depression): a trial of psychological therapy in addition to treatment with an SSRI for depressio

Not Applicable

• Conditions: Depression; Mental and Behavioural Disorders; Affective disorders

• Registration Number: ISRCTN37448835
• Lead Sponsor: niversity of Bristol

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-12
• Last Update Posted: 24 June 2024
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 84

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

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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

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 <20cm apart will be discussed with the radiographer).
10.7 Body Mass Index >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

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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 <20cm apart; tattoos to the head, neck or genital area
10.7 Body Mass Index >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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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<br>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:<br>2.1. Revised Clinical Interview Schedule (CIS-R) - a detailed psychiatric instrument that will give an ICD10 diagnosis<br>2.2. Patient Health Questionnaire (PHQ-9) - a brief measure of depressive symptoms<br>2.3. General Anxiety Disorder questionnaire (GAD-7) - a brief measure of anxiety<br>2.4. Quality of Life Enjoyment and Satisfaction Questionnaire (QLES) - a brief measure of life enjoyment and satisfaction.<br>2.5. Snaith-Hamilton Pleasure Scale (SHAPS) - a measure of anhedonia