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Behavioural Intervention

Psychotherapy for Depression

N/A

Waitlist Available

Led By Flavio Frohlich

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants/clients must be between ages 18 and 30

Participants/clients must have the capacity to understand study procedures (informed consent)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up immediately post-intervention

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to understand how the brains of clients and therapists may synchronize during therapy for depression. The study will compare two types of therapy - behavioral activation and psychoeducation - to see which is more effective

Who is the study for?

This trial is for individuals experiencing stress, depression, or anxiety. Participants should be willing to discuss their mental and physical health, attend a therapy session where their brain activity will be measured, and complete follow-up surveys.

What is being tested?

The study aims to compare the effects of Behavioral Activation (a type of cognitive-behavioral therapy) with Psychoeducation on people with depression symptoms by measuring how well client-therapist brain activities sync during sessions.

What are the potential side effects?

Since this trial involves psychotherapy interventions rather than medication, there are no direct side effects like those associated with drugs. However, discussing sensitive topics may cause temporary emotional discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 30 years old.

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I understand the study and can give informed consent.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during the intervention session, approximately 60 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during the intervention session, approximately 60 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and during the intervention session, approximately 60 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Inter-brain phase synchronization in Alpha frequency band via Phase Locking Value

Inter-brain phase synchronization in Theta frequency band via Phase Locking Value

Secondary study objectives

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

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

Directed inter-brain connectivity in the Alpha frequency band via Granger Causality

+1 more

Other study objectives

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)

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)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Behavioral ActivationExperimental Treatment1 Intervention

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.

Group II: PsychoeducationActive Control1 Intervention

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

First Studied

Drug Approval Stage

How many patients have taken this drug

Behavioral Activation

2013

Completed Phase 3

~2900

0 / 2Eligibility criteria met