Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
45 participants
INTERVENTIONAL
2025-04-11
2026-06-30
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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 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 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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
18 Years
30 Years
ALL
No
Sponsors
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Foundation of Hope, North Carolina
OTHER
University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Principal Investigators
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Flavio Frohlich
Role: PRINCIPAL_INVESTIGATOR
Carolina Center for Neurostimulation
Locations
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Carolina Center for Neurostimulation
Chapel Hill, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Flavio Frohlich, PhD
Role: primary
Zachary Stewart
Role: backup
References
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Kazdin AE. Understanding how and why psychotherapy leads to change. Psychother Res. 2009 Jul;19(4-5):418-28. doi: 10.1080/10503300802448899.
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.
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.
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.
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.
Other Identifiers
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22-1422
Identifier Type: -
Identifier Source: org_study_id