Skip to content

Effect of a digital mindfulness intervention for mild-to-moderate late-life depression: A randomized controlled trial.

Kemeng Zhu, Maoxin Hu, Chaomeng Liu, Yida Wang, Chengwei Guo, Haotian Shen, Nan Ding, Xiao Wang, Li Ren, Qinge Zhang

Journal of Psychiatric Research June 6, 2026 DOI: 10.1016/j.jpsychires.2026.05.037 (opens in new tab)

Relevant Not relevant

Study at a glance

AI-extracted from the abstract
Characteristics Randomized controlled trial Peer reviewed
Sample size 54
Population Older adults with mild-to-moderate late-life depression
Duration 6-week intervention
Measures HAMD-17, HAMA, PSQI, MOCA, frontal EEG spectral activity
Topics Anxiety Depression Meditation
Keywords Humans Electroencephalography Aged Female Digital media EEG Randomized controlled trial Alpha waves Theta waves Late-life depression Digital mindfulness
Key findings The digital mindfulness intervention with EEG feedback reduced depressive symptoms (HAMD-17), anxiety (HAMA), and sleep disturbances (PSQI), and improved cognition (MOCA) compared with general health education, with higher response and remission rates. Exploratory EEG analysis showed increased frontal theta and alpha activity. The authors conclude that FocusZen-based digital mindfulness may benefit mild-to-moderate late-life depression, potentially accompanied by enhanced frontal theta and alpha activity.

Abstract

Background: Late-life depression (LLD) is a growing public health concern in aging populations. Although digital mindfulness interventions show promise for depression, anxiety, and insomnia, their efficacy and electroencephalogram (EEG) correlates in older adults with LLD remain unclear. This study evaluated the FocusZen Mindfulness Stress Reduction System, a digital mindfulness intervention with EEG feedback, in mild-to-moderate LLD.

Methods: Fifty-four participants with mild-to-moderate LLD were randomly assigned to a 6-week intervention group (n = 27; daily FocusZen sessions) or a control group (n = 27; general health education). The primary outcome was the change in HAMD-17 score. Secondary outcomes included anxiety, sleep quality, cognition, and frontal EEG spectral activity. Data were analyzed using mixed-effects models and intention-to-treat principles.

Results: The intervention group demonstrated significant reductions in depressive symptoms [HAMD-17: F(3, 132.69) = 8.83, P < 0.001], anxiety [HAMA: F(3, 129.95) = 8.34, P < 0.001], and sleep disturbances [PSQI: F(3, 128.91) = 5.55, P = 0.01], alongside improved cognition [MOCA: F(3, 133.19) = 5.14, P = 0.01]. Response and remission rates were higher in the intervention group. Exploratory EEG analysis showed increased frontal theta [F(1.96, 43.12) = 25.28, P < 0.001] and alpha activity [F(1.44, 31.73) = 22.92, P < 0.001].

Conclusions: FocusZen-based digital mindfulness reduced depressive, anxiety, and sleep symptoms and improved cognition in mild-to-moderate LLD, potentially accompanied by enhanced frontal theta and alpha activity.

Trial Registration: Chinese Clinical Trial Registry Identifier: ChiCTR2400086063; https://www.chictr.org.cn/.

Comparable studies

Other randomized controlled trials on depression, most cited first.

Study Year Design Participants
A Randomized Trial of an N-methyl-D-aspartate Antagonist in Treatment-Resistant Major Depression Subjects with DSM-IV major depression (treatment resistant) 2006 Randomized, placebo-controlled, double-blind crossover study n = 18
Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. Recovered recurrently depressed patients 2000 Randomized controlled trial n = 145
Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: A randomized double-blind trial Cancer patients with life-threatening diagnoses and symptoms of depression and/or anxiety 2016 Randomized controlled trial n = 51
Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer: a randomized controlled trial Patients with cancer-related anxiety and depression 2016 Double-blind, placebo-controlled, crossover trial n = 29
Mindfulness-Based Cognitive Therapy for Depression: Replication and Exploration of Differential Relapse Prevention Effects. Recovered recurrently depressed patients 2004 Randomized controlled trial n = 73

Citations in the library

Cites 7

and 2 more in the library

Related reading

Explore topics

Anxiety Depression Meditation