Using Functional MRI Neurofeedback to Modulate Self-blame in Major Depressive Disorder (NCT05455827) | Clinical Trial Compass
CompletedNot Applicable
Using Functional MRI Neurofeedback to Modulate Self-blame in Major Depressive Disorder
United Kingdom20 participantsStarted 2023-02-28
Plain-language summary
To determine the feasibility of functional MRI neurofeedback in reducing overgeneralised self-blame in patients with depression
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Capacity to consent. Participants will be asked to complete consent before trial begins
* Understanding of verbal and written information given in English
* Online access
* Aged 18 or over
* Male or female
* Clinical diagnosis of MDD, with the following characteristics:
* Meets Diagnostic and Statistical Manual V (DSM-V) criteria for MDD
* Experience of a previous major depressive episode (MDE) lasting at least two months (evidence of recurrent depression)
* Patients must have stable symptoms, lasting at least six weeks before experimental group randomisation
* Exhibiting at least partial treatment resistance, evidenced by insufficient response to at least one psychological intervention or antidepressant intervention
* Current use of antidepressants is not basis for exclusion, but patients must be on a stable dose for at least six weeks without improvement before the study start, and must remain at this dose throughout the study
Exclusion Criteria:
* Standard reasons for being unable to undergo MRI (e.g. metal implants)
* Impairments of vision or hearing which cannot be corrected for during the treatment sessions
* Pregnant or breastfeeding
* History of manic or hypomanic episodes, or schizophreniform or schizophrenia symptoms, or substance abuse
* History of violent behaviour or aggressive impulses
* History of neurological disorders such as seizures, loss of consciousness following brain injury or medical disorders affecting brain functio…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.