Efficacy and Mechanisms of Internet-delivered MBCT for Adjustment Disorder During the COVID-19 Pandemic: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 301
- 试验地点
- 1
- 主要终点
- Change in Adjustment Disorder symptoms
研究概览
简要总结
This study tested a 4-week, internet-based Mindfulness-Based Cognitive Therapy (MBCT) program designed to help people experiencing adjustment disorder during the COVID-19 pandemic. Adjustment disorder is a stress-related condition that can cause anxiety, depression, and difficulty coping after major life changes.
We compared the online MBCT program to two other groups: an internet-based relaxation training program and a wait-list group. A total of 301 adults from Poland took part. We measured symptoms of adjustment disorder, depression, and anxiety before the program, right after, and one month later.
Results showed that the online MBCT program led to greater improvements in depression and anxiety than the other two groups. People in MBCT also developed more self-compassion and were better able to distance themselves from unhelpful thoughts, which helped reduce their symptoms. Benefits lasted at least one month after the program ended.
These findings suggest that a brief, self-guided, online mindfulness program can be an effective, accessible way to support mental health during stressful times such as a pandemic.
详细描述
Background and Rationale Adjustment disorder (AjD) is a stress-related mental health condition characterized by maladaptive emotional and behavioral responses to an identifiable stressor. Core symptoms include persistent preoccupation with the stressor and difficulty adapting, often accompanied by anxiety, depressed mood, and avoidance behaviors. According to ICD-11 criteria, AjD symptoms emerge within three months of a stressor and typically resolve within six months after the stressor ends, although in many cases they can persist longer and contribute to chronic distress.
Epidemiological studies indicate that AjD is highly prevalent, affecting up to 30% of clinical populations and a substantial proportion of the general public during times of widespread stress. Despite this, AjD remains understudied compared to mood and anxiety disorders. Few empirically validated psychological interventions are available, and existing treatment recommendations are often extrapolated from evidence on depression and anxiety.
The COVID-19 pandemic presented a unique context in which AjD rates surged globally. Fear of infection, prolonged social isolation, economic uncertainty, and disruption of daily life contributed to high levels of stress-related distress. Surveys during the pandemic indicated that 18-43% of adults in Europe reported symptom patterns consistent with AjD, underscoring the urgent need for scalable interventions that could be delivered remotely and at low cost.
Mindfulness-Based Cognitive Therapy (MBCT) MBCT is an eight-week, group-based psychological program originally developed to prevent relapse in recurrent depression. It combines mindfulness meditation practices with cognitive-behavioral therapy strategies, fostering non-judgmental awareness of present-moment experience, greater cognitive flexibility, and reduced reactivity to negative thoughts and emotions.
Mechanistic research suggests that MBCT works by:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants are required to be (a) at least 18 years old, (b) have access to the Internet, (c) currently experiencing some form of psychological distress related to COVID-19 pandemic, such as stress, anxiety, and/or low mood, and d) have the willingness to commit to a free online intervention program with two pre and post measurements online, within four weeks.
排除标准
- •(a) participating simultaneously in any pharmaceutical or psychosocial therapy, (b) if they were suffering from a current or lifetime psychotic disorder, bipolar disorder, or substance abuse problem; (c) if they reported current suicidal tendencies, (d) if they did not meet criteria for Adjustment Disorder (less than 47,5 points in ADNM-20 questionnaire), (e) participated in the past or currently in any of 8 weeks mindfulness programs (e.g., MBSR, MBCT).
研究组 & 干预措施
Internet-Delivered Mindfulness-Based Cognitive Therapy (iMBCT)
Internet-Delivered Mindfulness-Based Cognitive Therapy (iMBCT) Participants received a 4-week, unguided online adaptation of Mindfulness-Based Cognitive Therapy. The program consisted of six sequential modules delivered via a secure web platform, introducing mindfulness meditation, body scan, mindful movement, and cognitive-behavioral exercises. Content was provided through audio recordings, written materials, and reflective exercises. Supportive reminder emails were sent, but no therapist guidance was given.
干预措施: Mindfulness-Based Cognitive Therapy (Internet-delivered) (Behavioral)
Internet-Delivered Progressive Muscle Relaxation (iPMR)
Participants received a 4-week, unguided online progressive muscle relaxation program adapted from Bernstein and Borkovec's protocol. The program consisted of six sequential modules teaching systematic tensing and releasing of major muscle groups, gradually reducing the number of groups over time until relaxation could be achieved through recall alone. Audio guidance, written instructions, and reminder emails were provided without therapist involvement.
干预措施: Progressive Muscle Relaxation (Internet-delivered) (Behavioral)
Waitlist Control (WLC)
Participants were placed on a 4-week waitlist without active intervention. They completed all study assessments on the same schedule as intervention arms. At the end of the waiting period, they were offered the choice to participate in either the iMBCT or iPMR program.
干预措施: No Intervention - Waitlist Control (Behavioral)
结局指标
主要结局
Change in Adjustment Disorder symptoms
时间窗: Baseline (Week 0) and Post-intervention (Week 4)
Change in Adjustment Disorder symptoms from baseline to post-intervention, measured by the Adjustment Disorder New Module - 20 (ADNM-20). The ADNM-20 is a validated self-report questionnaire assessing ICD-11 Adjustment Disorder symptoms, including preoccupation and failure to adapt. Scores range from 0 to 60, with higher scores indicating greater symptom severity.
Remission Rates from Adjustment Disorder
时间窗: Baseline (Week 0) and Post-intervention (Week 4)
Instrument: Adjustment Disorder New Module - 20 (ADNM-20) Proportion of participants scoring below the clinical cutoff (\>47.5) on the ADNM-20 at post-intervention, indicating remission from probable Adjustment Disorder.
次要结局
- Change in Cognitive Fusion(Baseline (Week 0), Post-intervention (Week 4), Follow-up (Week 8))
- Change in Self-Compassion(Baseline (Week 0), Post-intervention (Week 4), Follow-up (Week 8))
- Change in Experiential Avoidance(Baseline (Week 0), Post-intervention (Week 4), Follow-up (Week 8))
- Change in Depressive Symptoms(Baseline (Week 0), Post-intervention (Week 4), Follow-up (Week 8))
- Change in Anxiety Symptoms(Baseline (Week 0), Post-intervention (Week 4), Follow-up (Week 8))
研究者
Paweł Holas
MD, PhD
University of Warsaw