MobACT: An Internet-Based Intervention for Chronic Pain Patients

Official title

MOBACT: An Internet-Based Guided Self-Help Intervention Based on Acceptance and Commitment Therapy for Chronic Pain

Overview

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.

Detailed description

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.

Data management follows strict procedures to ensure confidentiality, integrity, and secure storage. All participant information is de-identified and stored on encrypted servers with access restricted to authorized study personnel. Statistical analyses will compare outcomes between groups and explore potential mediators and moderators of treatment effects. Cost-effectiveness will be evaluated from both healthcare and societal perspectives, accounting for resource utilization, productivity losses, and implementation costs.

The intervention is expected to improve acceptance of chronic pain, psychological flexibility, coping behaviors, sleep quality, and overall quality of life, while reducing pain intensity, interference, catastrophizing, and emotional distress. Insights gained from the trial will contribute to understanding the mechanisms of change in internet-delivered ACT programs and inform the development of scalable psychological interventions for chronic pain.

Interventions

• Other Internet-based intervention
  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: 1. Creative hopelessness 2. Willingness and acceptance of pain 3. Defusion from negative thoughts 4. Committed action and values 5. Values and goal setting 6. Will

Primary outcome measures

• Chronic Pain Acceptance [Time frame: T0 (baseline); T1 (7-weeks); T2 (6 months)]

Secondary outcome measures (10)

• Pain Intensity and Pain Interference [Time frame: T0 (baseline); T1 (7-weeks); T2 (6 months)]
• Quality of Life [Time frame: T0 (baseline); T1 (7-weeks); T2 (6 months)]
• Sleep Quality [Time frame: T0 (baseline); T1 (7-weeks); T2 (6 months)]
• Central Sensitization [Time frame: T0 (baseline); T1 (7-weeks); T2 (6 months)]
• Pain Catastrophizing [Time frame: T0 (baseline); T1 (7-weeks); T2 (6 months)]
• Psychological Flexibility [Time frame: T0 (baseline); T1 (7-weeks); T2 (6 months)]
• Self-Efficacy [Time frame: T0 (baseline); T1 (7-weeks); T2 (6 months)]
• Coping [Time frame: T0 (baseline); T1 (7-weeks); T2 (6 months)]
• Anxiety [Time frame: T0 (baseline); T1 (7-weeks); T2 (6 months)]
• Depression [Time frame: T0 (baseline); T1 (7-weeks); T2 (6 months)]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Italy · 3 centers

• Alma Mater Studiorum of Bologna — Bologna
• Catholic University of Sacred Heart — Milan
• University of Verona — Verona

Sweden · 1 center

• University of Linkoping — Linköping

Publications

• Vugts MAP, Joosen MCW, van der Geer JE, Zedlitz AMEE, Vrijhoef HJM. The effectiveness of various computer-based interventions for patients with chronic pain or functional somatic syndromes: A systematic review and meta-analysis. PLoS One. 2018 May 16;13(5):e0196467. doi: 10.1371/journal.pone.0196467. eCollection 2018. PMID 29768436
• Vlaescu G, Alasjo A, Miloff A, Carlbring P, Andersson G. Features and functionality of the Iterapi platform for internet-based psychological treatment. Internet Interv. 2016 Oct 3;6:107-114. doi: 10.1016/j.invent.2016.09.006. eCollection 2016 Nov. PMID 30135819
• Sleed M, Eccleston C, Beecham J, Knapp M, Jordan A. The economic impact of chronic pain in adolescence: methodological considerations and a preliminary costs-of-illness study. Pain. 2005 Dec 15;119(1-3):183-190. doi: 10.1016/j.pain.2005.09.028. Epub 2005 Nov 16. PMID 16297552
• Scott W, Hann KE, McCracken LM. A Comprehensive Examination of Changes in Psychological Flexibility Following Acceptance and Commitment Therapy for Chronic Pain. J Contemp Psychother. 2016;46:139-148. doi: 10.1007/s10879-016-9328-5. Epub 2016 Mar 2. PMID 27397934
• Schutze R, Rees C, Smith A, Slater H, Campbell JM, O'Sullivan P. How Can We Best Reduce Pain Catastrophizing in Adults With Chronic Noncancer Pain? A Systematic Review and Meta-Analysis. J Pain. 2018 Mar;19(3):233-256. doi: 10.1016/j.jpain.2017.09.010. Epub 2017 Nov 6. PMID 29122652
• Savoia E, Fantini MP, Pandolfi PP, Dallolio L, Collina N. Assessing the construct validity of the Italian version of the EQ-5D: preliminary results from a cross-sectional study in North Italy. Health Qual Life Outcomes. 2006 Aug 10;4:47. doi: 10.1186/1477-7525-4-47. PMID 16901340
• Sanders GD, Neumann PJ, Basu A, Brock DW, Feeny D, Krahn M, Kuntz KM, Meltzer DO, Owens DK, Prosser LA, Salomon JA, Sculpher MJ, Trikalinos TA, Russell LB, Siegel JE, Ganiats TG. Recommendations for Conduct, Methodological Practices, and Reporting of Cost-effectiveness Analyses: Second Panel on Cost-Effectiveness in Health and Medicine. JAMA. 2016 Sep 13;316(10):1093-103. doi: 10.1001/jama.2016.12 PMID 27623463
• Pietrabissa G, Semonella M, Marchesi G, Mannarini S, Castelnuovo G, Andersson G, Rossi AA. Validation of the Italian Version of the Web Screening Questionnaire for Common Mental Disorders. J Clin Med. 2024 Feb 19;13(4):1170. doi: 10.3390/jcm13041170. PMID 38398481

Identifiers

NCT: NCT07270588 · CUP J53D23008130008

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗