Recruiting

Psychotherapy

Sponsor:

University of North Carolina, Chapel Hill

Code:

NCT06696001

Conditions

Depression

Eligibility Criteria

Sex: All

Age: 18 - 30

Healthy Volunteers: Not accepted

Interventions

Psychoeducation

Behavioral Activation

Study Details

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.

Conditions

Depression

Study ID

NCT06696001

Start date

Apr 11, 2025

Status verified date

Dec, 2025

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 30

Healthy Volunteers: Not accepted

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 Design

Enrollment

45 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Psychoeducation

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 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 outcome measure

  • Inter-brain phase synchronization in Alpha frequency band via Phase Locking Value [ Time Frame: During the interventional session, approximately 60 minutes ]
  • Inter-brain phase synchronization in Theta frequency band via Phase Locking Value [ Time Frame: During the interventional session, approximately 60 minutes ]

Central Contacts and Locations

Central contacts

Flavio Frohlich

(919) 966-4584flavio_frohlich@med.unc.edu

Zachary Stewart

zachary_stewart@med.unc.edu

Locations

Carolina Center for Neurostimulation

Recruiting

Chapel Hill, North Carolina, United States, 27516

Contacts

Flavio Frohlich, PhD

919-966-4584flavio_frohlich@med.unc.edu

Zachary Stewart

zachary_stewart@med.unc.edu

More Information

Sponsor

University of North Carolina, Chapel Hill

Last update posted

Aug 27, 2026

Last verified

Dec, 2025

Keywords

  • EEG
  • Hyperscanning
  • Therapeutic Alliance
  • Psychoeducation
  • behavioral activation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill on 2026-08-27.