Neuroscience of Psychotherapy for Depression
August 25, 2026 updated by: University of North Carolina, Chapel Hill
Interbrain Synchronization of the Therapist-Client Dyad in Psychotherapy: Pilot EEG Study in Students With Mild-Moderate Depression Symptoms
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Flavio Frohlich
- Phone Number: (919) 966-4584
- Email: flavio_frohlich@med.unc.edu
Study Contact Backup
- Name: Zachary Stewart
- Email: zachary_stewart@med.unc.edu
Study Locations
-
-
North Carolina
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Chapel Hill, North Carolina, United States, 27516
- Recruiting
- Carolina Center for Neurostimulation
-
Contact:
- Flavio Frohlich, PhD
- Phone Number: 919-966-4584
- Email: flavio_frohlich@med.unc.edu
-
Contact:
- Zachary Stewart
- Email: zachary_stewart@med.unc.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Psychoeducation
Psychoeducation will be used in this study as a control condition.
The 60 minute session will be structured to provide general educational information on depression and evidence-based strategies to reduce symptoms.
The information will be presented in generic format and will not be tailored to be client-specific.
|
For the psychoeducation session, the focus is for the therapist to engage with the client regarding mental health broadly without a targeted effort to reinforce therapeutic alliance or to offer individualized guidance or techniques.
The session will provide educational information on depression, depression symptoms and known causes, and strategies to reduce depression symptoms.
The content will be delivered in a fashion to avoid individualization and psychotherapeutic exchange.
The elements will focus on components of Cognitive Behavioral Therapy (CBT), differentiating between thoughts and feelings, common cognitive shortcuts, and the connection between behavior and emotion.
|
|
Experimental: Behavioral Activation
Behavioral Activation (BA) is a psychotherapy modality that can be used to treat depression.
The 60 minute session of BA is designed to actively engage with the client in creating personalized goals and ways in which maladaptive coping mechanisms maintaining depression can be addressed and replaced with increased exposure to positive reinforcement.
|
Behavioral Activation (BA) is a psychotherapy treatment modality used for depression and focuses on replacing maladaptive coping mechanism that reinforce depressive symptoms with adaptive coping mechanisms to increase exposure to positive reinforcement.
The treatment will consist of the following elements: Introduction to establish concept of positive reinforcement and build rapport, identification of client-centered values, individualized values-based activity planning and scheduling, and developing adaptive coping strategies for the future.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Inter-brain phase synchronization in Alpha frequency band via Phase Locking Value
Time Frame: During the interventional session, approximately 60 minutes
|
Inter-brain synchronization will be calculated for the Alpha frequency band via phase locking value during the interventional session for both study arms and will be used to assess any potential differences in Alpha frequency inter-brain synchronization between groups
|
During the interventional session, approximately 60 minutes
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Inter-brain phase synchronization in Theta frequency band via Phase Locking Value
Time Frame: During the interventional session, approximately 60 minutes
|
Inter-brain synchronization will be calculated for the theta frequency band via phase locking value during the interventional session for both study arms and will be used to assess any potential differences in Theta frequency inter-brain synchronization between groups
|
During the interventional session, approximately 60 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Directed inter-brain connectivity in theta frequency band via Granger Causality
Time Frame: During the intervention session, approximately 60 minutes
|
The Granger causality test is a statistical hypothesis test that helps decide whether one time series can predict another and will be used to determine directed inter-brain connectivity.
Granger causality will be calculated in the Theta frequency band during the interventional session for the Behavioral Activation arm to compare the direction of the connectivity as a function of the therapeutic elements.
|
During the intervention session, approximately 60 minutes
|
|
Directed inter-brain connectivity in the Alpha frequency band via Granger Causality
Time Frame: During the intervention session, approximately 60 minutes
|
The Granger causality test is a statistical hypothesis test that helps decide whether one time series can predict another and will be used to determine directed inter-brain connectivity.
Granger causality will be calculated in the Alpha frequency band during the interventional session for the Behavioral Activation arm to compare the direction of the connectivity as a function of the therapeutic elements.
|
During the intervention session, approximately 60 minutes
|
|
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
Time Frame: Baseline Up to 4 weeks post-intervention session
|
Alpha frequency band phase locking values calculated at the interventional session will be correlated with difference scores on Beck's Depression Inventory II from baseline to 4 weeks post intervention.
The Beck's Depression Inventory is a 21-item instrument that measures characteristics and symptoms of depression.
Possible scores range from 0-63, with lower scores indicating a better outcome with decreased symptoms of depression.
Total difference scores on the BDI will be correlated with inter-brain phase synchronization to determine if there is a significant relationship between inter-brain phase synchronization in the alpha frequency band and change in depression symptoms 4 weeks post-intervention from baseline.
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Baseline Up to 4 weeks post-intervention session
|
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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
Time Frame: Baseline Up to 4 weeks post-intervention session
|
Theta frequency band phase locking values calculated at the interventional session will be correlated with difference scores on Beck's Depression Inventory II from baseline to 4 weeks post intervention.
The Beck's Depression Inventory is a 21-item instrument that measures characteristics and symptoms of depression.
Possible scores range from 0-63, with lower scores indicating a better outcome with decreased symptoms of depression.
Total difference scores on the BDI will be correlated with inter-brain phase synchronization to determine if there is a significant relationship between inter-brain phase synchronization in the alpha frequency band and change in depression symptoms 4 weeks post-intervention from baseline.
|
Baseline Up to 4 weeks post-intervention session
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
Time Frame: immediately post-intervention
|
The correlation between inter-brain phase synchronization in the theta frequency band and therapeutic alliance will be calculated using Pearson's Correlation Coefficient.
Pooled Phase Locking value for each study arm will be correlated with pooled scores on the Working Alliance Inventory Short Form-Revised, a 12 item measure with a minimum score of 12 and a maximum score of 60.
Both measures being correlated are collected at the immediately post-intervention.
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immediately post-intervention
|
|
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)
Time Frame: immediately post-intervention
|
The correlation between inter-brain phase synchronization in the alpha frequency band and therapeutic alliance will be calculated using Pearson's Correlation Coefficient.
Pooled Phase Locking value for each study arm will be correlated with pooled scores on the Working Alliance Inventory Short Form-Revised, a 12 item measure with a minimum score of 12 and a maximum score of 60.
Both measures being correlated are collected at the immediately post-intervention.
|
immediately post-intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Flavio Frohlich, Carolina Center for Neurostimulation
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Kazdin AE. Understanding how and why psychotherapy leads to change. Psychother Res. 2009 Jul;19(4-5):418-28. doi: 10.1080/10503300802448899.
- Wampold BE. How important are the common factors in psychotherapy? An update. World Psychiatry. 2015 Oct;14(3):270-7. doi: 10.1002/wps.20238.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 11, 2025
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
June 30, 2027
Study Registration Dates
First Submitted
November 15, 2024
First Submitted That Met QC Criteria
November 15, 2024
First Posted (Actual)
November 19, 2024
Study Record Updates
Last Update Posted (Actual)
August 27, 2026
Last Update Submitted That Met QC Criteria
August 25, 2026
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22-1422
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
IPD Sharing Time Frame
Beginning 9 and continuing for 36 months following publication
IPD Sharing Access Criteria
Investigator has approved IRB, IEC, REB and an executed a data use/sharing agreement with UNC.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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