What side effects are associated with this type of intervention?

Common treatments for depression, such as SSRIs, can cause side effects like nausea, insomnia, sexual dysfunction, and weight gain. Psychotherapy, including CBT, may lead to emotional discomfort. Emerging VR-based therapies, like Virtual Reality-Reward Training, have shown mild side effects such as dizziness, nausea, and eye strain, which are generally less severe compared to pharmacotherapy.

What prior FDA approvals exist?

The FDA has approved several pharmacological treatments for depression, including selective serotonin reuptake inhibitors (SSRIs) like fluoxetine and sertraline, serotonin-norepinephrine reuptake inhibitors (SNRIs) like venlafaxine, and atypical antidepressants like bupropion. While Virtual Reality-Reward Training (VR-RT) represents a novel approach focusing on enhancing positive affect through immersive experiences, similar FDA-approved treatments for depression primarily involve medications that modulate neurotransmitter levels to improve mood and affect. As of now, there are no FDA-approved VR-based treatments specifically for depression, but ongoing research may pave the way for such innovative therapies in the future.

What other types of research exist?

Promising, novel alternatives to Virtual Reality-Reward Training for depression patients include: 1) Transcranial Magnetic Stimulation (TMS), which uses magnetic fields to stimulate nerve cells in the brain to improve symptoms of depression. 2) Neurofeedback, which involves training patients to regulate their brain activity through real-time feedback. 3) Mind-Body Therapies such as yoga and Qigong massage, which have shown benefits in improving mood and reducing stress. 4) Digital Cognitive Behavioral Therapy (CBT) programs, which offer structured therapy sessions through online platforms, making them accessible and convenient.

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VR-Reward Training for Depression (VR-RT Trial)

Phase 1

Recruiting

Led By Michelle G Craske, Ph.D

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

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

Must have

At least 18 years old

Be older than 18 years old

Must not have

Self-reported seizures within the last year and/or a diagnosis of epilepsy

Current use of psychotropic medications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to follow-up (week 12)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new virtual reality therapy to help adults with depression enjoy positive experiences more. It targets those who struggle with feeling pleasure and aims to improve their mood by using happy virtual reality scenarios.

Who is the study for?

This trial is for adults who feel very little pleasure or interest in activities (anhedonia), may be experiencing depression, and have trouble functioning daily. They must speak English fluently, not be on psychotropic drugs, and agree not to start other psychological treatments during the study. People with bipolar disorder, psychosis, substance use issues in the last six months, or those prone to motion sickness can't join.

What is being tested?

The study tests if Virtual Reality-Reward Training (VR-RT), which uses VR to help people enjoy positive experiences more deeply, is better than a control activity called Virtual Reality-Memory Training (VR-MT) at improving mood and reducing symptoms of depression over seven weeks.

What are the potential side effects?

Potential side effects are not detailed but could include discomfort from using VR such as dizziness or nausea especially for those prone to motion sickness. There's also a risk of emotional distress given the focus on mental health.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had seizures or been diagnosed with epilepsy in the past year.

Select...

I am currently taking medication for my mental health.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to follow-up (week 12)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to follow-up (week 12)

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to follow-up (week 12) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Depression, Anxiety, and Stress Scales (DASS-21)

MASQ-AD 14 Item

The Positive Affect and Negative Affect Schedule-Expanded Form (PANAS X) (General Dimensions Scales)

Secondary study objectives

Behavioral Activation Scale (BAS)

Effort Reward Trade-off Task

Positive Valence Systems Scale (PVSS-21)

+3 more

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: Virtual Reality-Reward Training (VR-RT)Experimental Treatment1 Intervention

7 sessions of positive VR immersion and positive memory specificity training exercises designed to savor rewarding features of immersion followed by memory specificity training exercises to savor rewarding features of autobiographical memory.

Group II: Virtual Reality-Memory Training (VR-MT)Active Control1 Intervention

7 sessions of neutral VR immersion and neutral memory specificity training exercises, designed to train memory of objective non-emotional stimuli followed by memory exercises to neutral autobiographical memories.

0 / 3Eligibility 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, such as Cognitive Behavioral Therapy (CBT), pharmacotherapy, and Mindfulness-Based Cognitive Therapy (MBCT), work through various mechanisms to alleviate symptoms. CBT focuses on changing negative thought patterns and behaviors, while pharmacotherapy adjusts neurotransmitter levels to improve mood. MBCT combines cognitive therapy with mindfulness to reduce rumination and increase present-moment awareness. Virtual Reality-Reward Training (VR-RT) enhances the savoring of positive experiences through guided imaginal recounting following immersion in positive VR experiences, aiming to increase positive affect and counteract anhedonia. These treatments are crucial as they offer diverse approaches to manage and reduce depressive symptoms, improving patients' overall quality of life.

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