Depression
Conditions
Keywords
EEG, Hyperscanning, Therapeutic Alliance, Psychoeducation, behavioral activation
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.
Detailed 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.
Interventions
BEHAVIORALPsychoeducation
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.
BEHAVIORALBehavioral 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.
Sponsors
University of North Carolina, Chapel Hill
Foundation of Hope, North Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inter-brain phase synchronization in Alpha frequency band via Phase Locking Value | 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 |
| Inter-brain phase synchronization in Theta frequency band via Phase Locking Value | 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
| Measure | Time frame | Description |
|---|---|---|
| Directed inter-brain connectivity in theta frequency band via Granger Causality | 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. |
| Directed inter-brain connectivity in the Alpha frequency band via Granger Causality | 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. |
| 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 | 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. |
| 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 | 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. |
Countries
United States
Contacts
CONTACTFlavio Frohlich
CONTACTZachary Stewart
PRINCIPAL_INVESTIGATORFlavio Frohlich
Carolina Center for Neurostimulation
Outcome results
None listed