MobACT: An Internet-Based Intervention for Chronic Pain Patients

NCT07270588 | Recruiting

• 1 other identifier: CUP J53D23008130008
• Study Type: interventional
• Target: 140
• Locations: 2 countries
• Sites: 4

Brief Summary

Chronic Pain (CP) is a condition characterized by pain that lasts or recurs for more than three months in one or more parts of the body. This type of pain is often accompanied by emotional distress and difficulties in daily functioning, which can interfere with a person's ability to carry out everyday activities and maintain social roles. As a result, it places a considerable burden not only on individuals but also on national healthcare systems, due to both direct medical costs and indirect costs such as reduced work productivity and increased use of health services. Traditional treatments for CP, such as medications and surgical procedures, often fail to provide sufficient relief or significantly improve the quality of life of those affected. This has led to growing interest in alternative approaches that can offer more lasting and comprehensive support. In this context, psychological therapies have gained increasing attention, particularly Acceptance and Commitment Therapy, or ACT. This therapeutic approach focuses not only on the reduction of physical symptoms but also on helping people accept their pain as part of their lived experience. The goal is to promote emotional well-being and improve overall functioning by increasing what is known as psychological flexibility. ACT is particularly relevant for people suffering from CP, as it helps them lead a meaningful life despite the presence of pain. Instead of avoiding or fighting the pain, individuals are encouraged to accept it while committing to actions that align with their personal values. This process supports emotional regulation and encourages engagement in activities that bring a sense of purpose and satisfaction. However, access to this type of psychological intervention remains limited in many contexts. Barriers such as long waiting lists, lack of trained professionals, geographic distance from treatment centers, stigma associated with psychological therapy, and patients' physical limitations often make it difficult for those in need to receive adequate care. In response to these challenges, recent years have seen the development of new forms of digital health support. In particular, internet-delivered self-help programs have emerged as a promising solution for the treatment of CP. These programs can reach individuals who might otherwise be unable to access care and offer a flexible, low-cost, and convenient alternative to traditional face-to-face therapy. Research has shown that ACT can be effectively adapted and delivered online, allowing people to benefit from its therapeutic principles in a format that fits their needs and lifestyles. The current study aims to evaluate the effectiveness of a guided online self-help program based on Acceptance and Commitment Therapy for individuals with CP. The program is designed to help participants accept their pain and focus on improving their quality of life through value-based actions. The study will also explore the psychological mechanisms that may explain how and why the intervention works, with the goal of improving the design and delivery of future programs. Furthermore, the study will examine the cost-effectiveness of this type of digital intervention, in order to assess its potential for broader implementation within public health systems. By increasing access to evidence-based psychological care through digital platforms, this research seeks to contribute to more effective, inclusive, and sustainable treatment options for those living with chronic pain.

Conditions

Chronic Pain

Keywords

Chronic Pain; Internet-based intervention; clinical psychology; acceptance and commitment therapy

Outcome Measures

Primary Outcomes (1)

• Acceptance of Chronic Pain

  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.

  T0 (baseline); T1 (7-weeks); T2 (6 months)

Secondary Outcomes (10)

• 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)

Study Arms (2)

7-weeks Internet-based interventions

EXPERIMENTAL

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. Willingness exercises 7. Maintenance of learned strategies.

Other: Internet-based intervention

7-Weeks Waiting list

NO INTERVENTION

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.

Interventions

Internet-based intervention OTHER

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. Willingness exercises 7. Maintenance of learned strategies.

7-weeks Internet-based interventions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS Policlinico di Sant'Orsola, University Alma Mater Studiorum of Bologna, Italy: collaborator
• Catholic University of the Sacred Heart: lead
• Università degli studi di Verona: collaborator
• Linkoeping University: collaborator

Study Sites (4)

Alma Mater Studiorum of Bologna

Bologna, Italy

RECRUITING

Catholic University of Sacred Heart

Milan, Italy

RECRUITING

University of Verona

Verona, Italy

RECRUITING

University of Linkoping

Linköping, Sweden

RECRUITING

Related Publications (33)

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  BACKGROUND

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gianluca Castelnuovo, Ph.D.

  Catholic University of Sacred Heart of Milan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle Semonella

CONTACT

+972559876070; michelle.semonella@unicatt.it

Giada Pietrabissa

CONTACT

giada.pietrabissa@unicatt.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 26, 2025
• First Posted: December 8, 2025
• Study Start: April 15, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 30, 2026
• Last Updated: December 8, 2025

Record last verified: 2025-07

Locations

SE (1); IT (3)