No evidence of increased gaming-related problems with long-term use of a video game therapeutic: Exploratory endpoint findings from a randomized controlled trial

This randomized controlled trial demonstrates that long-term use of the video game therapeutic Meliora for major depressive disorder does not increase gaming-related problems, even with high engagement or immersion, supporting the safety of video games as a medium for digital therapeutics.

The Gist

Imagine you have a broken leg. You need physical therapy to heal, but the exercises are boring, painful, and you keep skipping them. Now, imagine if that physical therapy was hidden inside a fun, exciting video game. You'd probably play it every day, and your leg would heal faster. This is the promise of video game therapeutics: using games to treat serious mental health issues like depression.

But there's a catch. People worry: "If we make depression treatment into a video game, won't people get addicted to the game itself? Will they start playing too much and ignoring their real lives?"

This paper is like a safety inspector checking that specific worry. Here is what they found, explained simply:

The Experiment: The "Meliora" Game

The researchers created a video game called Meliora. It wasn't just for fun; it was designed to train your brain's "executive functions" (like focus, planning, and emotional control) to help treat depression.

To see if the game was safe, they ran a massive test with 1,001 adults who had depression. They split them into three groups:

1. The Real Game Group: Played Meliora (the actual therapy).
2. The "Sham" Group: Played a game that looked and sounded exactly the same as Meliora, but it had the "therapy" parts turned down. Think of it like a placebo pill that looks real but has no medicine.
3. The Normal Care Group: Just got their usual doctor visits and therapy, no video game.

They watched these groups for 12 weeks.

The Big Question: Did They Get "Addicted"?

The researchers used a standard checklist called the Gaming Addiction Scale (GAS-7) to see if anyone started having problems with their gaming habits. They looked for signs like:

• Playing so much it ruined their sleep or work.
• Feeling anxious when they couldn't play.
• Lying about how much they played.

The Surprising Results

Here is the good news: The game did not make people addicted.

• No Spike in Problems: People who played the real game (Meliora) did not end up with more gaming problems than the people who played the fake game or just saw their doctor. In fact, the people playing the game actually saw a slight decrease in gaming-related worries by the end of the study.
• More Play = No Trouble: Usually, if you play a video game for 50 hours a week, you might worry about addiction. But in this study, even the people who played the most (some played over 45 hours) did not develop gaming problems. The amount of time they played didn't predict whether they would get "addicted."
• Immersion is Safe: People often say, "I got so lost in the game I forgot to eat!" (This is called immersion). The researchers worried that being "too immersed" might be dangerous. They found that even when people felt deeply immersed in the game, it didn't turn into a problem. It was like being absorbed in a great book or movie, not like a dangerous addiction.

The "Why" Behind the Safety

Why didn't the game become an addiction? The authors suggest a few reasons, like safety features built into the game:

1. No Social Traps: The game was single-player. It didn't have chat rooms or competitive leaderboards that often drive people to play for hours to "win" or impress others.
2. Time Limits: The game had a "curfew." It wouldn't let you play more than 90 minutes a day. It was like a parent setting a timer on a child's tablet.
3. Purpose: The game felt like work (in a good way) because it was helping them feel better, not just a mindless distraction.

The Bottom Line

Think of this study as a "safety certification" for video games used in medicine.

For a long time, doctors and parents were afraid that using video games to treat mental illness was like giving a diabetic patient a candy bar to help them feel better—it just didn't make sense. This study proves that if you design the game carefully (with time limits and no toxic social features), you can use the "candy" of a video game to deliver the "medicine" of therapy without the side effects of addiction.

It's a green light for the future: Video games can be a safe, powerful, and engaging tool to help people heal, without turning them into gamers who can't stop playing.

Technical Summary

1. Problem Statement

Digital mental health interventions (DMHIs) and digital therapeutics (DTx) often suffer from low patient engagement and high dropout rates, limiting their clinical efficacy. Video game therapeutics have emerged as a promising solution to improve engagement through immersive, interactive mechanisms. However, a significant barrier to their widespread adoption is the concern among clinical stakeholders that long-term exposure to video game mediums may inadvertently induce or exacerbate gaming-related problems (e.g., addiction, dependency). Prior to this study, no randomized controlled trial (RCT) had empirically tested whether long-term use of a video game therapeutic increases gaming-related symptoms.

2. Methodology

The study was a pre-registered, exploratory endpoint analysis conducted within a larger, three-arm, randomized, double-blinded, comparator-controlled superiority trial (ClinicalTrials.gov NCT05426265) involving adults with Major Depressive Disorder (MDD) in Finland.

• Participants:
  • Cohort: 1,001 patients (Intention-to-Treat, ITT).
  • Demographics: Mean age 33.4 years (SD 9.3); 64% female.
  • Inclusion/Exclusion: Diagnosed with MDD (via MINI interview); explicitly excluded individuals with existing gambling or gaming addictions (defined by specific thresholds on the Problem Gambling Severity Index and Gaming Addiction Scale).
• Interventions:
  • Meliora (Active): A video game therapeutic delivering adaptive executive functions training (EFT) in a single-player format.
  • Sham (Comparator): A highly similar video game matching audiovisual and narrative features of Meliora but with reduced EFT training load.
  • Treatment-as-Usual (TAU): Standard care without the digital intervention.
  • Protocol: Recommended usage was 48 hours over 12 weeks (max 90 mins/day), used at home on personal computers.
• Measures:
  • Primary Outcome: Gaming-related problems measured by the Gaming Addiction Scale (GAS-7) at baseline (Week 0), Weeks 4, 8, 12 (post-intervention), and Week 24 (follow-up).
  • Secondary/Exploratory Measures: Intervention use hours, experienced immersion (Immersive Experiences Questionnaire - IEQ), and demographic covariates.
• Statistical Analysis:
  • Primary Analysis: Robust linear mixed-effects models to evaluate between-group differences in GAS-7 change-from-baseline, adjusted for baseline scores, age, gender, education, income, and life status.
  • Correlation Analysis: Robust linear regression to assess associations between GAS-7 changes and total use hours or immersion scores.
  • Deterioration Analysis: Calculation of the percentage of participants showing ≥25% and ≥50% relative increases in GAS-7 scores from baseline to post-intervention.
  • Cohorts: Analyses were performed on the ITT cohort and a Per-Protocol (PP) completer cohort (participants with ≥24 hours of use).

3. Key Contributions

• First Clinical Evidence: This is the first RCT to provide clinical evidence regarding the safety of long-term video game therapeutic use concerning gaming-related problems.
• Safety Validation: It directly addresses the "addiction risk" hypothesis, demonstrating that therapeutic use does not equate to problematic gaming patterns when risks are mitigated.
• Distinction of Immersion: The study empirically distinguishes between "experienced immersion" (a therapeutic goal) and "gaming-related problems," showing they are not correlated in this context.
• Dose-Response Safety: It establishes that even high adherence (≥24 hours, up to ~45 hours) does not correlate with increased gaming problems.

4. Key Results

• GAS-7 Score Changes (ITT Cohort):
  • Meliora: GAS-7 scores significantly decreased from baseline to Week 12 ($p = 8.1 \times 10^{-4}$).
  • TAU: GAS-7 scores also significantly decreased ($p = 6.0 \times 10^{-6}$).
  • Sham: No significant change was observed ($p = 0.39$).
  • Between-Group: Meliora reduced GAS-7 scores more than Sham (adjusted mean difference = -0.27, $p = 6.0 \times 10^{-6}$). No significant difference was found between Meliora and TAU.
• Correlations with Usage and Immersion:
  • Use Hours: No significant association was found between total intervention use hours and changes in GAS-7 scores (Meliora: $p = 0.17$; Sham: $p = 0.28$).
  • Immersion: No significant association was found between experienced immersion (IEQ) and GAS-7 changes (Meliora: $p = 0.93$; Sham: $p = 0.19$).
• Deterioration Rates:
  • The rate of worsening (≥25% increase in GAS-7) was low and comparable across all arms: Meliora (10.7%), Sham (12.7%), and TAU (11.4%).
  • At the stricter ≥50% threshold, rates were 3.0% (Meliora), 3.5% (Sham), and 4.4% (TAU). No statistically significant differences existed between groups.
• Per-Protocol Analysis:
  • Results in the high-adherence cohort (≥24 hours use) corroborated the ITT findings, confirming that even intensive use did not lead to increased gaming-related problems.

5. Significance

• Clinical Safety: The study provides robust evidence that video game therapeutics can be safely deployed for long-term treatment of mental health conditions (specifically MDD) without inducing gaming addiction or related problems.
• Risk Mitigation: The findings suggest that specific design features—such as restricting daily use time (90 mins cap), removing social interaction features, and excluding individuals with pre-existing addictions—are effective strategies for mitigating potential risks.
• Therapeutic Mechanism: The results support the hypothesis that "immersion" in a therapeutic context is distinct from "problematic gaming." High engagement and immersion are prerequisites for efficacy and do not inherently lead to adverse outcomes.
• Future of Digital Therapeutics: These findings remove a major barrier to the adoption of video game therapeutics, suggesting that the video game medium is a viable and safe vehicle for delivering digital health interventions, potentially improving engagement and clinical outcomes compared to traditional non-gaming DTx.