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NCT Number: NCT06696001

Neuroscience of Psychotherapy for Depression

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psychoeducation

Behavioral

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 Activation

Behavioral

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.

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Other outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Flavio Frohlich

CONTACT

[email protected]

(919) 966-4584

Zachary Stewart

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Foundation of Hope, North Carolina

Registry information

Official study title

Interbrain Synchronization of the Therapist-Client Dyad in Psychotherapy: Pilot EEG Study in Students With Mild-Moderate Depression Symptoms

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 19, 2024
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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