DepressionNCT06696001
Neuroscience of Psychotherapy for Depression
A study testing Psychoeducation and Behavioral Activation in people with Depression, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Depression
- What is being tested?
- Psychoeducation and Behavioral Activation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Zachary Stewart contact
United States1 site, 1 recruiting
- Recruiting
Carolina Center for Neurostimulation
Chapel Hill, North Carolina, 27516
Flavio Frohlich, PhD, 919-966-4584, flavio_frohlich@med.unc.edu
Zachary Stewart, zachary_stewart@med.unc.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Depression
- Being tested
- Psychoeducation, Behavioral Activation
- Keywords
- EEG, Hyperscanning, Therapeutic Alliance, Psychoeducation, behavioral activation
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychoeducationBehavioural
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.
Behavioral ActivationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Psychoeducation | Active comparator | 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. Receives: Behavioral: Psychoeducation |
| Behavioral Activation | Experimental | 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. Receives: Behavioral: Behavioral Activation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inter-brain phase synchronization in Alpha frequency band via Phase Locking Value
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
Measured: During the interventional session, approximately 60 minutes
Inter-brain phase synchronization in Theta frequency band via Phase Locking Value
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
Measured: During the interventional session, approximately 60 minutes
Secondary outcomes (4)
Directed inter-brain connectivity in theta frequency band via Granger Causality
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.
Measured: During the intervention session, approximately 60 minutes
Directed inter-brain connectivity in the Alpha frequency band via Granger Causality
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.
Measured: 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
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.
Measured: Baseline Up to 4 weeks post-intervention session
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
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.
Measured: Baseline Up to 4 weeks post-intervention session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start11 Apr 2025
- Primary completion1 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation of Hope, North Carolina
- Responsible party
- Sponsor
- Investigators
- Flavio Frohlich, Principal investigator, Carolina Center for Neurostimulation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06696001
- Sponsor's protocol ID
- 22-1422
- Status last verified
- Dec 2025
- First submitted
- 15 Nov 2024
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Kazdin AE. Understanding how and why psychotherapy leads to change. Psychother Res. 2009 Jul;19(4-5):418-28. doi: 10.1080/10503300802448899.
PubMed 19034715Wampold BE. How important are the common factors in psychotherapy? An update. World Psychiatry. 2015 Oct;14(3):270-7. doi: 10.1002/wps.20238.
PubMed 26407772Hougaard 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.
PubMed 8191262Safran 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.
PubMed 10718606Dumas 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.
PubMed 20808907
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interbrain Synchronization of the Therapist-Client Dyad in Psychotherapy: Pilot EEG Study in Students With Mild-Moderate Depression Symptoms
- ClinicalTrials.gov ID
- NCT06696001
- Acronym / sponsor ID
- 22-1422
- Conditions
- Depression
- Keywords
- EEG, Hyperscanning, Therapeutic Alliance, Psychoeducation, behavioral activation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Foundation of Hope, North Carolina
- Study start
- 11 Apr 2025 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 19 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Psychoeducation | Active comparator | Behavioral: PsychoeducationPsychoeducation 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. |
| Behavioral Activation | Experimental | Behavioral: Behavioral ActivationBehavioral 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (10 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PsychoeducationFor 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. | Behavioural | Psychoeducation |
| Behavioral ActivationBehavioral 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. | Behavioural | Behavioral Activation |
Primary outcome
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
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
4 secondary outcomes
Directed inter-brain connectivity in theta frequency band via Granger Causality
Time frame: 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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Background: PubMed 19034715Kazdin AE. Understanding how and why psychotherapy leads to change. Psychother Res. 2009 Jul;19(4-5):418-28. doi: 10.1080/10503300802448899.
- Background: PubMed 26407772Wampold BE. How important are the common factors in psychotherapy? An update. World Psychiatry. 2015 Oct;14(3):270-7. doi: 10.1002/wps.20238.
- Background: PubMed 8191262Hougaard 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.
- Background: PubMed 10718606Safran 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.
- Background: PubMed 20808907Dumas 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zachary Stewart contact
Flavio Frohlich principal investigator
Carolina Center for Neurostimulation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducation and Behavioral Activation in people with Depression, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Flavio Frohlich ((919) 966-4584, flavio_frohlich@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inter-brain phase synchronization in Alpha frequency band via Phase Locking Value (time frame: During the interventional session, approximately 60 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06696001, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.