What is the mechanism of action of this treatment?

Common treatments for depression include Cognitive Behavioral Therapy (CBT), Interpersonal Psychotherapy (IPT), and Mindfulness-Based Cognitive Therapy (MBCT). CBT focuses on changing negative thought patterns and behaviors, IPT addresses interpersonal issues and social functioning, and MBCT combines mindfulness practices with cognitive therapy to prevent relapse. These therapies often aim to enhance the Positive Valence System (PVS), which is associated with experiencing pleasure and motivation. Understanding these mechanisms is crucial for depression patients as it helps tailor treatments that can effectively engage their PVS, potentially improving their response to therapy and overall quality of life.

What side effects are associated with this type of intervention?

Common treatments for depression include pharmacotherapy and psychotherapy. Antidepressants, such as SSRIs, can cause side effects like nausea, weight gain, sexual dysfunction, and insomnia. Cognitive Behavioral Therapy (CBT) and Interpersonal Psychotherapy (IPT) are psychotherapeutic approaches with minimal physical side effects, though they may initially increase anxiety or emotional distress as patients confront challenging issues. Novel psychotherapies focusing on the Positive Valence System through social rewards aim to enhance engagement and may have fewer side effects, primarily involving emotional discomfort during therapy sessions.

What prior FDA approvals exist?

The FDA has approved several antidepressants for the treatment of depression, including SSRIs like escitalopram and fluoxetine, and SNRIs like duloxetine. These medications have shown efficacy in reducing depressive symptoms, with some patients responding better to switching medications if initial treatments are ineffective. The novel streamlined psychotherapy being studied focuses on engaging the Positive Valence System (PVS) through social rewards, which is a different approach compared to traditional pharmacotherapy. This method aims to enhance behavioral activation and improve depressive symptoms by leveraging social interactions and rewards.

What other types of research exist?

Promising novel alternatives to Novel Streamlined Psychotherapy for depression patients in 2024 include Cognitive Behavioral Therapy (CBT), Metacognitive Therapy, Electroconvulsive Therapy (ECT), Vagus Nerve Stimulation (VNS), and Deep Brain Stimulation (DBS). These therapies have demonstrated efficacy in various studies, particularly for treatment-resistant depression.

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Engage & Connect Therapy for Depression

N/A

Recruiting

Led By Nili Solomonov, PhD

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

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

Must have

Diagnosis of unipolar major depressive disorder without psychotic features, determined by the SCID

Mini Mental Status Exam (MMSE) ≤ 1 SD below the mean score for patient's age and education

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, mid-treatment (week 5) and post treatment (week 9)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new talk therapy for older adults with depression. The therapy focuses on positive social interactions to activate brain areas that make people feel good, aiming to improve mood and motivation.

Who is the study for?

This trial is for individuals aged 50-85 with major depressive disorder, a MADRS score ≥ 20, and stable mental status. They must be on a steady antidepressant dose or off medication for 8 weeks and able to consent. Excluded are those with suicidal intent, other psychiatric/neurological disorders, certain medical conditions, or contraindications to MRI scanning.

What is being tested?

'Engage & Connect' psychotherapy aims at activating the brain's reward system during social interactions in older adults with depression. The study will use neuroimaging and computational modeling to predict who benefits most from this therapy compared to standard Symptom Review and Psychoeducation (SRP).

What are the potential side effects?

Since this trial involves psychotherapy rather than medication, side effects may include emotional discomfort or distress due to discussing personal issues during therapy sessions.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with major depression without psychosis.

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My mental function test score is slightly below average for my age and education.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, mid-treatment (week 5) and post treatment (week 9)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, mid-treatment (week 5) and post treatment (week 9)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, mid-treatment (week 5) and post treatment (week 9) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in Resting State fMRI Connectivity of the Positive Valence System

Secondary study objectives

Change in Behavioral Activation for Depression Scale (BADS)

Change in Montgomery Asberg Depression Rating Scale (MADRS)

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: "Engage & Connect" PsychotherapyExperimental Treatment1 Intervention

"Engage \& Connect", a modified adapted version of "Engage". Its principal intervention is "social reward exposure" - facilitating engagement in rewarding and meaningful social activities with significant others. In "Engage-S" therapy, individuals with depression work with a therapist to develop "action plans" to pursue rewarding social activities of their choice.

Group II: Symptom Review and Psychoeducation (SRP)Active Control1 Intervention

In this intervention, the therapist will review the participant's symptoms and provide literature-based clinical explanations and clarifications about the symptoms, the course, and the causes of depression. In SRP, the therapist reviews the depressed individual's symptoms, and level of information on depression, identifies misconceptions, and guides selection of educational material which could benefit the patient.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for depression include Cognitive Behavioral Therapy (CBT), Interpersonal Psychotherapy (IPT), and Mindfulness-Based Cognitive Therapy (MBCT). CBT focuses on changing negative thought patterns and behaviors, IPT addresses interpersonal issues and social functioning, and MBCT combines mindfulness practices with cognitive therapy to prevent relapse. These therapies often aim to enhance the Positive Valence System (PVS), which is associated with experiencing pleasure and motivation. Understanding these mechanisms is crucial for depression patients as it helps tailor treatments that can effectively engage their PVS, potentially improving their response to therapy and overall quality of life.

Psychological therapies for anxiety and depression in children and adolescents with long-term physical conditions.