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 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.

Conditions

Chronic Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Chronic Pain Acceptance

  The Chronic Pain Acceptance Questionnaire (CPAQ) (20 items) is used to assess acceptance of 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

• Catholic University of the Sacred Heart: lead
• 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: October 1, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): October 30, 2027
• Last Updated: May 19, 2026

Record last verified: 2025-07

Locations

SE (1); IT (3)