MOBACT: An Internet-Based Guided Self-Help Intervention Based on Acceptance and Commitment Therapy for Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 4
- 主要终点
- Acceptance of Chronic Pain
研究概览
简要总结
Chronic Pain (CP) is a condition characterized by pain lasting or recurring for more than three months, often accompanied by emotional distress and difficulties in daily functioning. CP represents a major burden for individuals and healthcare systems due to its impact on quality of life, healthcare utilization, and work productivity. Traditional treatments, such as pharmacological and surgical approaches, frequently provide insufficient relief, highlighting the need for complementary interventions.
Among psychological approaches, Acceptance and Commitment Therapy (ACT) has shown promising results for CP management. ACT aims to increase psychological flexibility by helping individuals accept pain as part of their experience while engaging in meaningful, value-based activities. Rather than focusing exclusively on symptom reduction, ACT promotes emotional well-being, functioning, and quality of life. However, access to psychological interventions remains limited because of barriers such as long waiting lists, geographical distance, physical limitations, stigma, and limited availability of trained professionals.
Digital health interventions, particularly internet-delivered self-help programs, may help overcome these barriers by providing flexible, accessible, and cost-effective support. Previous research suggests that ACT can be effectively adapted to online formats, allowing broader dissemination and increased accessibility for individuals with CP.
The present study aims to evaluate the effectiveness of a guided internet-delivered ACT-based self-help intervention for individuals with CP. The intervention seeks to support pain acceptance, improve quality of life, and promote engagement in valued activities. The study will also explore potential psychological mechanisms underlying treatment outcomes and assess the cost-effectiveness of the intervention to evaluate its potential implementation within public healthcare systems.
详细描述
Chronic Pain (CP) is a persistent condition characterized by emotional distress and functional impairment that is not better explained by another diagnosis. Its multifactorial nature includes biological, psychological, and social components that interact to maintain and exacerbate symptoms. Psychological processes such as pain-related fear, avoidance behaviors, catastrophizing, and reduced engagement in valued activities contribute to disability and diminished quality of life. Pharmacological and surgical treatments alone frequently provide insufficient improvement, underscoring the relevance of psychological interventions.
Acceptance and Commitment Therapy (ACT) is designed to improve psychological flexibility by promoting willingness to experience pain-related distress while pursuing personally meaningful behaviors. ACT-based interventions have shown effectiveness in addressing emotional and behavioral responses to pain, reducing disability, and improving overall functioning. Due to its modularity and transdiagnostic focus, ACT can be adapted for a wide range of CP presentations and is suitable for digital delivery.
Internet-based interventions (IBIs) are increasingly implemented to improve accessibility to psychological treatment. Digital delivery may reduce barriers related to mobility limitations, geographical distance, waiting lists, stigma, and limited availability of trained clinicians. Guided IBIs allow patients to engage with structured therapeutic content at their own pace, while also receiving support from a therapist. Internet-based ACT programs have demonstrated promising effects on pain acceptance, emotional functioning, behavioral flexibility, and pain-related disability.
The present randomized controlled trial aims to evaluate the effectiveness and cost-effectiveness of MobACT, a guided internet-based ACT intervention adapted for the Italian population. The program consists of seven weekly modules addressing core ACT processes, including acceptance, defusion, values clarification, and committed action. The intervention is delivered through the secure, research-oriented iTerapi platform, which provides access to treatment content, therapist communication, and assessment tools. Participants receive weekly notifications when new material is available and reminder messages if modules are not completed.
Participants complete baseline, post-treatment, and follow-up assessments through the platform. During treatment, additional weekly monitoring collects information on sleep quality and changes in pharmacological therapy for pain management. A subset of participants will take part in semi-structured qualitative interviews to explore their subjective treatment experience, usability perceptions, and acceptability of the digital format. Interview data will undergo thematic analysis.
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
- •Adults aged 18 years or older;
- •A verifiable medical diagnosis of Chronic Pain (duration ≥ 3 months);
- •Internet access;
- •Sufficient computer and internet literacy;
- •Fluent knowledge of the Italian language.
排除标准
- •Current participation in psychological or psychotherapeutic treatments for chronic pain management;
- •High risk of suicide;
- •Cognitive impairments;
- •Presence of certified psychiatric disorders, such as:
- •Psychotic disorders (e.g., schizophrenia, schizoaffective disorders, etc.);
- •Bipolar disorder (unstabilized manic or hypomanic episodes);
- •Severe depressive disorders (e.g., major depression, suicidal intent, or recent suicide attempts);
- •Severe personality disorders that impair the ability to carry out daily activities (e.g., work, self-care);
- •Cognitive or neurodegenerative disorders.
研究组 & 干预措施
7-Weeks Waiting list
Participants allocated to the waiting list control group will not receive the intervention during the initial seven-week study period. However, they will be granted full access to the treatment program after the seven weeks have elapsed.
7-weeks Internet-based interventions
Participants allocated to the experimental group will be asked to complete one module per week, each based on the core principles of Acceptance and Commitment Therapy (ACT). The treatment program consists of seven modules delivered weekly over a total duration of seven weeks. The content of the modules will cover the following topics:
- Creative hopelessness
- Willingness and acceptance of pain
- Defusion from negative thoughts
- Committed action and values
- Values and goal setting
- Willingness exercises
- Maintenance of learned strategies.
干预措施: Internet-based intervention (Other)
结局指标
主要结局
Acceptance of Chronic Pain
时间窗: T0 (baseline); T1 (7-weeks); T2 (6 months)
The Chronic Pain Acceptance Questionnaire (CPAQ) (20 items) is the primary method used to assess acceptance in individuals with chronic pain. Each item is rated on a scale from 0 ("Never true") to 6 ("Always true"), where the respondent indicates their level of agreement with each statement. The CPAQ is composed of two subscales: Activity Engagement (AE) and Pain Willingness (PW). To calculate the CPAQ score, the items corresponding to each subscale are summed to obtain a score for each domain. The total score, ranging from 0 to 120, is the sum of the two subscale scores. Higher scores indicate greater levels of pain acceptance. The Activity Engagement (AE) subscale measures the extent to which individuals continue to engage in daily activities regardless of their pain, while the Pain Willingness (PW) subscale assesses the extent to which individuals perceive that avoiding or controlling pain is an ineffective strategy.
次要结局
- Anxiety(T0 (baseline); T1 (7-weeks); T2 (6 months))
- Pain Intensity and Pain Interference(T0 (baseline); T1 (7-weeks); T2 (6 months))
- Quality of Life(T0 (baseline); T1 (7-weeks); T2 (6 months))
- Sleep Quality(T0 (baseline); T1 (7-weeks); T2 (6 months))
- Central Sensitization(T0 (baseline); T1 (7-weeks); T2 (6 months))
- Pain Catastrophizing(T0 (baseline); T1 (7-weeks); T2 (6 months))
- Psychological Flexibility(T0 (baseline); T1 (7-weeks); T2 (6 months))
- Self-Efficacy(T0 (baseline); T1 (7-weeks); T2 (6 months))
- Coping(T0 (baseline); T1 (7-weeks); T2 (6 months))
- Depression(T0 (baseline); T1 (7-weeks); T2 (6 months))
研究者
Gianluca Castelnuovo
Professor
Catholic University of the Sacred Heart