Understanding brain activity during therapy for depression
Interbrain Synchronization of the Therapist-Client Dyad in Psychotherapy: Pilot EEG Study in Students With Mild-Moderate Depression Symptoms
This study tests how brain activity changes in people with depression during a therapy session, comparing two different approaches to see which one helps more.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years to 30 Years |
| Sex | All |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT06696001 on ClinicalTrials.gov |
What this trial studies
This study investigates how client-therapist brain activity synchronizes during a psychosocial intervention aimed at alleviating depression symptoms. It compares two approaches: behavioral activation, a client-centered cognitive-behavioral therapy, and psychoeducation, which provides information on recovery strategies. Participants will attend a single session of one of these interventions while their brain activity is measured using EEG. They will also complete surveys about their mental and physical health before and after the session.
Who should consider this trial
Good fit: Ideal candidates are full-time students aged 18 to 30 experiencing mild to moderate depressive symptoms.
Not a fit: Patients with active suicidal ideation or a history of suicide attempts may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance therapeutic approaches for depression by understanding the neuroscience behind client-therapist interactions.
How similar studies have performed: While the specific approach of measuring brain synchronization during therapy is novel, related studies have shown promise in understanding therapeutic processes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria for participants/clients: * Between ages 18 and 30 * Full-time student status (undergraduate, graduate, and professional) * Experience mild to moderate depressive symptoms as determined by the Beck Depression Inventory (score: 14-28) * Capacity to understand study procedures (informed consent) * Ability to speak and understand English * Willingness to comply with study procedures Inclusion Criteria for therapists: * Ages 18 or older * Qualification to administer therapy (decided by the Principal Investigator) * Capacity to understand the study procedures (informed consent) * Speak and understand English * Willingness to comply with study procedures Exclusion Criteria for participants/clients: * Active, Current Suicidal ideation as determined by the Columbia-Suicide Severity Rating Scale (C-SSRS) in the past month * Past suicidal attempt (lifetime) * Recently initiated psychotherapy (past month) * Elevated psychosis risk based on self-report prodromal questionnaire - brief version (PQ-B) or self-reported diagnosis of psychotic disorder by mental health provider * Positive screen for autism spectrum disorder based on the self-report autism quotient (AQ-10) or self-reported diagnosis of autism spectrum disorder by mental health provider, * Daily intake of benzodiazepine of \>20 mg diazepam milligram equivalent * Inability to give informed, voluntary, written consent to participate * Inability to effectively communicate in English as determined by interaction with study personnel * Anything else that in the assessment of the study team is not conducive to the successful completion of the study requirements. There are no exclusion criteria for therapists
Where this trial is running
Chapel Hill, North Carolina
- Carolina Center for Neurostimulation — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Flavio Frohlich — Carolina Center for Neurostimulation
- Study coordinator: Flavio Frohlich
- Email: flavio_frohlich@med.unc.edu
- Phone: (919) 966-4584
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.