Using Functional MRI Neurofeedback to Modulate Self-blame in Major Depressive Disorder

NCT05455827 | Completed

• 1 other identifier: US_FMRI_NF_JMS1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the feasibility of functional MRI neurofeedback in reducing overgeneralised self-blame in patients with depression

Conditions

Depression

Keywords

Neurofeedback; fMRI; MDD

Outcome Measures

Primary Outcomes (1)

• BOLD activity in subgenual anterior cingulate

  Determine whether participants are able to modulate their anterior cingulate BOLD activity in keeping with the neurofeedback

  Acquired during the procedure

Secondary Outcomes (10)

• Montgomery Asberg Depression Rating Scale (MADRS

  2 weeks before and 2 weeks after fMRI neurofeedback intervention

• Rosenberg self-esteem scale

  2 weeks before and at weeks 2, 4 and 6 after the fMRI neurofeedback session

• Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR-16)

  2 weeks before and at weeks 2, 4 and 6 after the fMRI neurofeedback session

• Generalised Anxiety Disorder Assessment (GAD-7)

  2 weeks before and 2 weeks after fMRI neurofeedback intervention

• Positive and Negative Affect Schedule (PANAS)

  2 weeks before and 2 weeks after fMRI neurofeedback intervention

Study Arms (2)

Intervention A

EXPERIMENTAL

Enhancing condition differences between guilt and indignation BOLD activations of subgenual anterior cingulate cortex.

Other: fMRI neurofeedback (A)

Intervention B

ACTIVE COMPARATOR

Minimising condition differences between guilt and indignation BOLD activations of subgenual anterior cingulate cortex.

Other: fMRI neurofeedback (B)

Interventions

fMRI neurofeedback (A) OTHER

Participants will be shown feedback about the BOLD activation within the subgenual anterior cingulate cortex to enhance differences between the self-blame and other-blame conditions

Intervention A

fMRI neurofeedback (B) OTHER

Participants will be shown feedback about the BOLD activation within the subgenual anterior cingulate cortex to minimise differences between the self-blame and other-blame conditions

Intervention B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 function, blood flow or metabolism
• History of learning disabilities, major medical, developmental or relevant other axis-I disorders
• Prior specialist diagnosis of attention deficit hyperactivity disorder (ADHD), antisocial or borderline personality disorder
• Significant impairment of psychosocial functioning before the last MDE indicating the possibility of a comorbid personality disorder or autism spectrum disorder
• Current intake of benzodiazepines, GABAergic or benzodiazepine receptor agonists
• Current recreational drug use
• Having MDD with the following characteristics:
• Presenting with greater than 'low-risk' suicidality, violence or current self-harming behaviour
• Experiencing a current MDE lasting more than 12 months

Sponsors & Collaborators

• Brighton & Sussex Medical School: lead

Study Sites (1)

CISC, Brighton and Sussex Medical School.

Brighton, East Sussex, BN1 9RY, United Kingdom

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: July 13, 2022
• Study Start: February 28, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: August 7, 2024

Record last verified: 2024-08

Locations

GB (1)