Effect of brief online mindfulness-based cognitive therapy in patients with digital replantation: a study protocol for a randomized controlled trial.
Fanshan Huang, Weiwei Wang, Xin Miao, Mengna You, Meng Liu, Weiyan Tang, Jianli Lu
Trials April 13, 2026 DOI: 10.1186/s13063-026-09697-1 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial (protocol) Peer reviewed |
|---|---|
| Population | Patients undergoing digital replantation after traumatic amputation |
| Duration | 4-week intervention |
| Measures | Stanford Acute Stress Reaction Questionnaire (SASRQ), Connor-Davidson Resilience Scale (CD-RISC), General Self-Efficacy Scale (GSES), EuroQol Five-Dimensional Health Scale (EQ-5D) |
| Topics | PTSD Meditation |
| Keywords | Digital replantation Mindfulness-based cognitive therapy Randomized controlled trial Embct |
| Key findings | Proposes that a 4-week online mindfulness-based cognitive therapy (eMBCT) may reduce PTSD symptoms and improve psychological resilience, self-efficacy, and postoperative recovery in digital replantation patients, but the trial is still in protocol stage with no results reported. |
Abstract
Traumatic amputations are common traumatic injuries that require digital replantation to restore the form, function, and sensation of the hand. The post-surgical survival of replanted digits is influenced by multiple factors, including psychological factors such as posttraumatic stress disorder (PTSD), anxiety, and depression. Mindfulness-based cognitive therapy (MBCT) is considered a potential intervention to address such emotional distress. Traditionally, MBCT involves an 8-week face-to-face group format. Due to feasibility concerns regarding implementation and patient adherence, this study proposes a modified 4-week online version, referred to as brief online MBCT (eMBCT). This study is a two-arm randomized controlled clinical trial. The control group will receive standard postoperative nursing care, while the intervention group will receive the eMBCT for 4 weeks. The primary outcome measure is PTSD symptom severity, assessed using the Stanford Acute Stress Reaction Questionnaire (SASRQ). Secondary outcomes include the Connor-Davidson Resilience Scale (CD-RISC), the General Self-Efficacy Scale (GSES), the EuroQol Five-Dimensional Health Scale (EQ-5D), and postoperative recovery status. This study aims to investigate the effects of a brief eMBCT program on PTSD symptoms, psychological resilience, self-efficacy, and clinical outcomes-specifically the incidence of vascular crisis and hand function recovery-in patients undergoing digital replantation. ChiCTR2500101285 [Chinese Clinical Trial Registry; registered on 23 April 2025].