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Can cognitive behavioral additions improve the efficacy of self-help mindfulness intervention for depression and anxiety ?: A randomized controlled trial.

Ying Huang, Z. Chong, Zenan Dou, Hoyin Lo, Sisi Wang, Wei Xu

Behaviour Research and Therapy March 15, 2026 DOI: 10.1016/j.brat.2026.105020 (opens in new tab)

Study at a glance

AI-extracted from the abstract
Characteristics Randomized controlled trial Peer reviewed
Sample size 335
Population University students from various institutions across China experiencing moderate to severe emotional distress
Interventions Self-help mindfulness intervention (sMBI) Combined mindfulness and cognitive behavioral therapy intervention (sMBI + CBT) Waitlist control
Duration 60-day intervention, with follow-ups at three and six months
Topics Anxiety Depression Meditation
Key findings Both sMBI and sMBI + CBT significantly reduced depression and anxiety compared to waitlist, with no significant difference between the two interventions. The sMBI effect was sequentially mediated by mindfulness and psychological flexibility, while sMBI + CBT was mediated by mindfulness and reduced irrational beliefs.

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.

Comparable studies

Other randomized controlled trials on anxiety, most cited first.

Study Year Design Participants
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
Psilocybin can occasion mystical-type experiences having substantial and sustained personal meaning and spiritual significance Hallucinogen-naïve adults reporting regular participation in religious or spiritual... 2006 Double-blind study n = 36
Pilot Study of Psilocybin Treatment for Anxiety in Patients With Advanced-Stage Cancer Adults with advanced-stage cancer and anxiety 2010 Double-blind, placebo-controlled study n = 12

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