About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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.
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.

Treatment groups

45 Participants

are divided into 2 treatment groups

Group A: PsychoeducationActive comparator 1 intervention

Group B: Behavioral ActivationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame

During the interventional session, approximately 60 minutes

2

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

Time frame

During the interventional session, approximately 60 minutes

Secondary outcomes

1

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.

Time frame

During the intervention session, approximately 60 minutes

2

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.

Time frame

During the intervention session, approximately 60 minutes

3

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.

Time frame

Baseline Up to 4 weeks post-intervention session

4

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.

Time frame

Baseline Up to 4 weeks post-intervention session

Other outcomes

1

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.

Time frame

immediately post-intervention

2

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.

Time frame

immediately post-intervention

Neuroscience of Psychotherapy for Depression

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

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