Neuroscience of Psychotherapy for Depression

University of North Carolina (UNC)

Status: Enrolling

Conditions: Depression

Treatments: Behavioral: Behavioral Activation; Behavioral: Psychoeducation

Study type: Interventional

Funder types: Other

Identifiers

NCT06696001

22-1422

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 30 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 2 patient groups

Psychoeducation

Active Comparator group

Description:

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.

Treatment:

Behavioral: Psychoeducation

Behavioral Activation

Experimental group

Description:

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.

Treatment:

Behavioral: Behavioral Activation