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| Name | Class |
|---|---|
| Foundation of Hope, North Carolina | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Directed inter-brain connectivity in theta frequency band via Granger Causality | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | The correlation between inter-brain phase synchronization in the theta frequency band and therapeutic alliance will be calculated using Pearson's Correlation Coefficient. Pooled Phase Locking value for each study arm will be correlated with pooled scores on the Working Alliance Inventory Short Form-Revised, a 12 item measure with a minimum score of 12 and a maximum score of 60. Both measures being correlated are collected at the immediately post-intervention. |
Inclusion Criteria for participants/clients:
Inclusion Criteria for therapists:
Exclusion Criteria for participants/clients:
There are no exclusion criteria for therapists
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Flavio Frohlich | Contact | (919) 966-4584 | flavio_frohlich@med.unc.edu | |
| Zachary Stewart | Contact | zachary_stewart@med.unc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Flavio Frohlich | Carolina Center for Neurostimulation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carolina Center for Neurostimulation | Recruiting | Chapel Hill | North Carolina | 27516 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19034715 | Background | Kazdin AE. Understanding how and why psychotherapy leads to change. Psychother Res. 2009 Jul;19(4-5):418-28. doi: 10.1080/10503300802448899. | |
| 26407772 | 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. |
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Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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Beginning 9 and continuing for 36 months following publication
Investigator has approved IRB, IEC, REB and an executed a data use/sharing agreement with UNC.
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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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.
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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.
|
| 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. |
|
| During the intervention session, approximately 60 minutes |
| Directed inter-brain connectivity in the Alpha frequency band via Granger Causality | 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. | 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 | 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. | 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 | 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. | Baseline Up to 4 weeks post-intervention session |
| 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) | The correlation between inter-brain phase synchronization in the alpha frequency band and therapeutic alliance will be calculated using Pearson's Correlation Coefficient. Pooled Phase Locking value for each study arm will be correlated with pooled scores on the Working Alliance Inventory Short Form-Revised, a 12 item measure with a minimum score of 12 and a maximum score of 60. Both measures being correlated are collected at the immediately post-intervention. | immediately post-intervention |
| 8191262 | 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. |
| 10718606 | 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. |
| 20808907 | 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. |