Gaming for Good: Meet the First FDA-Approved Video Games for Depression

Parents playing video games at home during TMS treatment for depression

For most people, “video game” and “depression treatment” don’t sit naturally in the same sentence. Games are meant to distract, entertain, or fill in a commute. Treatment is meant to do the opposite: slow things down, take stock, and help someone function again.

Yet the gap between the two has been narrowing for years. The U.S. Food and Drug Administration (FDA) has already authorised a prescription video game for ADHD (EndeavorRx), which signalled that software can be assessed like a medical product when it’s designed for a clinical purpose.

Now the same idea has reached depression, though it looks less like a console title and more like a structured smartphone program with game-like tasks.

“Approved”, “cleared”, and why the wording matters

In everyday conversation, people often say “FDA-approved” as shorthand for “the FDA reviewed it”. Strictly speaking, many digital health tools enter the market through FDA “clearance” rather than the full “approval” pathway used for new drugs.

Rejoyn, the product attracting attention in depression care, sits in the cleared/authorised category as a Class II medical device (software as a medical device).

That might sound like bureaucratic hair-splitting, but it’s worth getting right. Clearance still requires evidence, labelling rules, and ongoing obligations. It also separates these products from the ocean of unregulated “wellness” apps that can promise the world and deliver very little.

Meet Rejoyn: a prescription app built around play-like tasks

Rejoyn is a prescription digital therapeutic intended to reduce symptoms of Major Depressive Disorder (MDD) when used as an add-on to clinician-managed outpatient care for adults aged 22 and over who are already taking antidepressant medication.

That indication carries two big implications:

  1. It’s not meant to replace existing care.
  2. It’s not a general self-help app for anyone feeling low.

So, what does a “video game for depression” actually involve?

  • Rejoyn combines brief CBT-based lessons with an interactive cognitive-emotional exercise called the Emotional Faces Memory Task.
  • The core activity asks users to identify and remember facial emotions across short sessions, a bit like a focused pattern-and-memory challenge that keeps you engaged because it behaves like a game.
  • The program is designed to run over six weeks, with an extension period where lesson content remains available.
  • It’s also built to nudge adherence. Supportive text messages reinforce the lesson content and prompt continued use, which matters because consistency is often where real-world treatment plans wobble.

What the evidence looks like (and what it doesn’t)

  • What the study was
    • Rejoyn was tested in a major clinical study called MIRAI.
    • It was set up so results were fair: people were randomly put into groups, and it used a sham (lookalike) app as the comparison.
  • Who was in it
    • Adults with major depressive disorder who were already taking antidepressants but still had symptoms.
    • The FDA indication for Rejoyn is for adults 22 years and over on antidepressant medication, used alongside clinician-managed outpatient care.
  • What people did
    • One group used the Rejoyn app.
    • The other group used a sham app that looked similar but didn’t include the key therapeutic parts.
    • The main program ran for 6 weeks, with an extra follow-on period afterwards.
  • What the researchers measured
    • They tracked changes in depression symptoms using a standard rating scale called MADRS, focusing on the change by week 6.
  • The simple question the study asked
    • If someone is on antidepressants and still not doing well, does adding Rejoyn help more than using a similar app that doesn’t contain the active treatment?
  • Why “remote” matters
    • People took part from home, using their phones rather than visiting a clinic for each session.
    • That matches real life, but it also means some people may stop using the app, and that can affect how results translate outside a study.
  • What this evidence does not prove
    • It doesn’t prove Rejoyn works as a standalone treatment. The FDA paperwork says it’s an add-on to clinician care and antidepressant medication.
    • It doesn’t guarantee the benefits last long-term for everyone, because the main outcome was measured over weeks, not years.

Why games for depression might appeal, and where caution is sensible

Sydney is busy, expensive, and not always kind to downtime. Many people are juggling long commutes, caring responsibilities, and waitlists for services. A prescribed, structured app that can be used at home may sound attractive for that reason alone.

Still, “accessible” isn’t the same as “right for everyone”. If you’re considering a prescribed digital therapeutic, it’s fair to ask:

  • What’s the intended role in my care plan: add-on, short-term support, or a skills refresher?
  • What evidence supports it for someone with my profile?
  • What data does it collect and how is it stored?
  • What should I do if symptoms worsen?

And it’s worth remembering that depression treatment is rarely one-size-fits-all. Some people respond well to psychological therapy. Others do best with medication, or a combination. Some look for non-drug approaches, including TMS therapy, when symptoms persist despite standard options. (That’s a separate clinical pathway, and it should be discussed with a qualified clinician.)

Also Read: Burned Out on Meds? Why More People Are Turning to TMS for Depression

What “gaming for good” really means

Calling Rejoyn a “video game for depression” is catchy, but the more useful idea is this: it borrows the parts of games that keep people engaged (short sessions, clear tasks, feedback loops) and puts them in service of a clinical aim.

That’s a promising direction, provided we keep our expectations realistic. A prescription app isn’t a magic fix, and it won’t suit everyone. It can, though, widen the menu of evidence-based choices, especially for people who need something structured between appointments.

If you’re in Sydney and weighing up options for depression, including newer digital tools and established non-drug approaches such as TMS treatment, start with a conversation with your GP or psychiatrist about what fits your history and current symptoms.

And if you or someone close to you is in immediate danger or at risk of self-harm, seek urgent help straight away (in Australia, you can contact Lifeline on 13 11 14 or Beyond Blue on 1300 22 4636).

Book a confidential consultation with our therapists to discuss whether transcranial magnetic stimulation is a suitable option for your depression symptoms and treatment history. Visit https://www.sydneytms.com.au/ or call 1300 177 144.

Frequently Asked Questions:

  1. What does TMS therapy do?
    TMS delivers magnetic pulses through a coil on the scalp to stimulate targeted brain circuits. For depression, it acts on areas involved in mood and is often considered when standard treatments haven’t helped enough.
  1. What is the success rate of TMS therapy?
    Outcomes vary. Across trials and reviews, about 40–50% of people show a clinical response and around 20–30% reach remission. Some real-world clinic datasets report higher rates, depending on the setting and definitions used.
  1. How effective is TMS for OCD?
    TMS is FDA-cleared for OCD. In the FDA-reviewed deep TMS study, Y-BOCS scores dropped by roughly 6 points at six weeks, compared with about 3 points in the sham group.
  1. Is TMS safe?
    It’s generally well tolerated. Common side effects include scalp discomfort or headache; serious side effects (such as seizures) are uncommon, and clinics screen for risks like certain metal implants. Your clinician will check suitability and discuss benefits and risks.
  1. How long does a course take?
    Sessions are usually done five days a week for 4–6 weeks. Many sessions last 3.5–20 minutes, and most people can return to normal activities straight afterwards.

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