Clinical trial NCT06696001: Neuroscience of Psychotherapy for Depression
Official title: Interbrain Synchronization of the Therapist-Client Dyad in Psychotherapy: Pilot EEG Study in Students With Mild-Moderate Depression Symptoms
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Keywords: EEG
Hyperscanning
Therapeutic Alliance
Psychoeducation
behavioral activation
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Foundation of Hope, North Carolina
First posted: 2024-11-19
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There are two interventions that the participants will randomly be assigned to. Each participant will only complete one of these two interventions during their duration in the study.
Primary purpose: TREATMENT

Brief summary: The goal of this study is to learn the extent to which client-therapist brain activity may synchronize during a psychosocial intervention for depression symptoms.

The study will compare behavioral activation, a client-centered type of cognitive-behavioral therapy, to psychoeducation which delivers information on strategies to recover from depression symptoms.

Participants will answer questions about their mental and physical health, attend one psychosocial intervention session receiving either Behavioral Activation or Psychoeducation with simultaneous brain activity measurement and complete follow up surveys two weeks and one month following the intervention.

Detailed description: This is a pilot study to investigate the neuroscience of a single-session psychosocial intervention for depression symptoms. Brain activity is measured with EEG in both research participant and therapist. Participants will fill in questionnaires about their depression symptoms and experience during the psychosocial intervention.

Eligibility 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)
* No current suicidal ideation, score of 0 on Columbia-Suicide Severity Rating Scale (C-SSRS in past month)
* 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

Primary outcomes:
measure: Inter-brain phase synchronization in Alpha frequency band via Phase Locking Value
timeFrame: During the interventional session, approximately 60 minutes
measure: Inter-brain phase synchronization in Theta frequency band via Phase Locking Value
timeFrame: During the interventional session, approximately 60 minutes
Secondary outcomes:
measure: Directed inter-brain connectivity in theta frequency band via Granger Causality
timeFrame: During the intervention session, approximately 60 minutes
measure: Directed inter-brain connectivity in the Alpha frequency band via Granger Causality
timeFrame: During the intervention session, approximately 60 minutes
measure: Correlation between Inter-brain Phase Synchronization in Alpha frequency band via phase locking value and change in depression symptoms via Beck Depression Inventory II (BDI) total score
timeFrame: Baseline Up to 4 weeks post-intervention session
measure: Correlation between Inter-brain Phase Synchronization in Theta frequency band via phase locking value and change in depression symptoms via Beck Depression Inventory II total score
timeFrame: Baseline Up to 4 weeks post-intervention session
Other outcomes:
measure: Correlation between inter-brain phase synchronization in theta frequency band via Phase Locking Value and therapeutic alliance via score on the Working Alliance Inventory (WAI)
timeFrame: immediately post-intervention
measure: Correlation between inter-brain phase synchronization in alpha frequency band via Phase Locking Value and therapeutic alliance via score on the Working Alliance Inventory (WAI)
timeFrame: immediately post-intervention
Locations:
city: Chapel Hill
country: United States
facility: Carolina Center for Neurostimulation
state: North Carolina
Study officials:
affiliation: Carolina Center for Neurostimulation
name: Flavio Frohlich
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Hougaard E. The therapeutic alliance--a conceptual analysis. Scand J Psychol. 1994 Mar;35(1):67-85. doi: 10.1111/j.1467-9450.1994.tb00934.x.
citation: Safran JD, Muran JC. Resolving therapeutic alliance ruptures: diversity and integration. J Clin Psychol. 2000 Feb;56(2):233-43. doi: 10.1002/(sici)1097-4679(200002)56:23.0.co;2-3.
citation: Dumas G, Nadel J, Soussignan R, Martinerie J, Garnero L. Inter-brain synchronization during social interaction. PLoS One. 2010 Aug 17;5(8):e12166. doi: 10.1371/journal.pone.0012166.