This randomized controlled trial enrolled 335 university students across China who were experiencing moderate to severe emotional distress. Participants were randomized to a self-help mindfulness intervention (sMBI), a combined mindfulness and cognitive behavioral therapy intervention (sMBI + CBT), or a waitlist control group (WL). The primary outcomes were reductions in symptoms of depression and anxiety.
Both sMBI and sMBI + CBT were significantly more effective than WL in reducing depression and anxiety symptoms. However, no significant differences were observed between sMBI and sMBI + CBT. Exact effect sizes, absolute numbers, and p-values were not reported.
Secondary analyses explored mechanisms. For sMBI, effects were sequentially mediated by increases in mindfulness and psychological flexibility. For sMBI + CBT, effects were sequentially mediated by increases in mindfulness and reductions in irrational beliefs.
Safety and tolerability were not reported. Limitations include the lack of reported effect sizes and absolute numbers, which limits the ability to assess clinical significance. The study was conducted entirely online, and generalizability to other populations or settings may be limited.
For clinicians, these findings suggest that scalable, self-help digital interventions may offer benefit for distressed students, but the absence of comparative effect sizes and safety data warrants cautious interpretation. Further research with more detailed reporting is needed.
View Original Abstract ↓
OBJECTIVES: This study evaluated the comparative efficacy of a self-help mindfulness intervention (sMBI) and a combined mindfulness and cognitive behavioral therapy intervention (sMBI + CBT) in reducing symptoms of depression and anxiety. Additionally, it explored the mechanisms underlying these interventions.
METHODS: In this randomized controlled trial (RCT), 335 university students from various institutions across China, all experiencing moderate to severe emotional distress, were randomly assigned to one of three groups: sMBI, sMBI + CBT, or a waitlist control group (WL). Interventions were delivered via an internet-based website over a 60-day period, with assessments conducted at baseline, during treatment, post-treatment, and at three-month and six-month follow-ups. An intention-to-treat (ITT) analysis using multilevel mixed-effects models was employed to estimate the effects of the interventions.
RESULTS: Both sMBI and sMBI + CBT were significantly more effective than WL in reducing symptoms of depression and anxiety. However, no significant differences were observed between sMBI and sMBI + CBT in their impact on depression and anxiety. The effects of sMBI on depression and anxiety were sequentially mediated by increases in mindfulness and psychological flexibility. In contrast, the effects of sMBI + CBT were sequentially mediated by increases in mindfulness and reductions in irrational beliefs.
CONCLUSIONS: This RCT confirms the efficacy of sMBI in reducing depression and anxiety through improvements in mindfulness and psychological flexibility. It also supports the efficacy of sMBI + CBT in alleviating depression by enhancing mindfulness and correcting irrational beliefs. However, the addition of CBT to sMBI does not appear to provide additional benefits in the treatment of depression and anxiety.
TRIAL REGISTRATION: Chictr.org Identifier: ChiCTR2300075928.https://www.chictr.org.cn/showproj.html?proj=207327.