Neuroscience of Psychotherapy for Depression

NCT06696001 | Recruiting

• 1 other identifier: 22-1422
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Keywords

EEG; Hyperscanning; Therapeutic Alliance; Psychoeducation; behavioral activation

Outcome Measures

Primary Outcomes (2)

• 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

  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

  During the interventional session, approximately 60 minutes

Secondary Outcomes (4)

• Directed inter-brain connectivity in theta frequency band via Granger Causality

  During the intervention session, approximately 60 minutes

• Directed inter-brain connectivity in the Alpha frequency band via Granger Causality

  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

  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

  Baseline Up to 4 weeks post-intervention session

Other Outcomes (2)

• 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)

  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)

  immediately post-intervention

Study Arms (2)

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.

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.

Behavioral: Behavioral Activation

Interventions

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.

Psychoeducation

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.

Behavioral Activation

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Foundation of Hope, North Carolina: collaborator
• University of North Carolina, Chapel Hill: lead

Study Sites (1)

Carolina Center for Neurostimulation

Chapel Hill, North Carolina, 27516, United States

RECRUITING

Related Publications (5)

• Kazdin AE. Understanding how and why psychotherapy leads to change. Psychother Res. 2009 Jul;19(4-5):418-28. doi: 10.1080/10503300802448899.

  PMID: 19034715 BACKGROUND

• 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.

  PMID: 26407772 BACKGROUND

• 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.

  PMID: 8191262 BACKGROUND

• 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.

  PMID: 10718606 BACKGROUND

• 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.

  PMID: 20808907 BACKGROUND

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Flavio Frohlich

  Carolina Center for Neurostimulation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Flavio Frohlich

CONTACT

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

Zachary Stewart

CONTACT

zachary_stewart@med.unc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The research assistants and personnel will be aware of the randomized intervention for each participant since this will be stored on an encrypted spreadsheet with a password. The participants will be made aware that they will be randomized to a group, however, they will not know what intervention they have been assigned to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: November 19, 2024
• Study Start: April 11, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: Beginning 9 and continuing for 36 months following publication
• Access Criteria: Investigator has approved IRB, IEC, REB and an executed a data use/sharing agreement with UNC.

Locations

US (1)