Chronic PainMobACTNCT07270588
MobACT: An Internet-Based Intervention for Chronic Pain Patients
A study testing Internet-based intervention in people with Chronic Pain, run by Catholic University of the Sacred Heart at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Internet-based intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 1 Oct 2025to 30 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
Show all 9Show fewer
- 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.
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Giada Pietrabissa contact
4 sites in 2 countries
Italy3 sites, 3 recruiting
- Recruiting
Alma Mater Studiorum of Bologna
Bologna
Silvana Grandi, silvana.grandi@unibo.it
- Recruiting
Catholic University of Sacred Heart
Milan
Gianluca Castelnuovo, Ph.D., gianluca.castelnuovo@unicatt.it
- Recruiting
University of Verona
Verona
Lidia Del Piccolo, lidia.delpiccolo@univr.it
Sweden1 site, 1 recruiting
- Recruiting
University of Linkoping
Linköping
Gerhard Andersson, gerhard.andersson@liu.se
About this study
Official title: MOBACT: An Internet-Based Guided Self-Help Intervention Based on Acceptance and Commitment Therapy for Chronic Pain
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.
Read more
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.
Read the 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.
- Conditions
- Chronic Pain
- Being tested
- Internet-based intervention
- Keywords
- Chronic Pain, Internet-based intervention, clinical psychology, acceptance and commitment therapy
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: T0 (baseline); T1 (7-weeks); T2 (6 months)
Secondary outcomes (10)
Pain Intensity and Pain Interference
The Brief Pain Inventory - Italian version (BPI-I) (10 items) consists of two subscales.
The first subscale assesses pain intensity using four Numerical Rating Scales, ranging from 0 ("no pain") to 10 ("pain as bad as you can imagine"), which measure current pain, worst pain, least pain, and average pain experienced over the past 24 hours.
The second subscale evaluates pain interference with various aspects of daily life, including general activity, walking, mood, sleep, work, relationships with others, and enjoyment of life. These are also rated on Numerical Rating Scales from 0 ("does not interfere") to 10 ("completely interferes").
The Italian version of the BPI has shown good internal consistency (Cronbach's alpha = 0.80), stability (rho = 0.789, p < 0.001), excellent inter-rater reliability (k = 0.945), and good homogeneity (alpha = 0.8).
Measured: T0 (baseline); T1 (7-weeks); T2 (6 months)
Quality of Life
The EuroQol-5D-3L (EQ-5D-3L) is a standardized instrument developed to assess quality of life. The questionnaire consists of two parts. The first part includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each rated on three levels of severity, from 1 ("no problems") to 3 ("extreme problems"). The second part features a Visual Analogue Scale (EQ VAS) that assesses the respondent's current perceived health on a scale from 0 ("worst imaginable health") to 100 ("best imaginable health").
The Italian version of the EQ-5D-3L has shown good reliability, with a Cronbach's alpha coefficient of 0.73.
Measured: T0 (baseline); T1 (7-weeks); T2 (6 months)
Sleep Quality
The Mini Sleep Questionnaire (MSQ) (10 items) evaluates sleep quality by assessing both sleep and wakefulness factors. Each item is rated on a Numerical Rating Scale (NRS) from 1 ("Never") to 7 ("Always"), referring to the respondent's experience over the past week.
The Italian version of the MSQ has demonstrated good internal consistency (Cronbach's alpha = 0.77), good test-retest reliability (ICC = 0.82), and factor analysis confirmed two dimensions (sleep and wakefulness) with Cronbach's alpha = 0.75 for both. Optimal cut-off values were identified (>16 for sleep and >14 for wakefulness), with an area under the curve greater than 0.80.
Measured: T0 (baseline); T1 (7-weeks); T2 (6 months)
Central Sensitization
The Central Sensitization Inventory (CSI) (35 items) measures current health symptoms related to central sensitization, yielding a total score ranging from 0 to 100. Items are rated on a scale from "never" (0) to "always" (4), with higher scores indicating greater presence of central sensitization symptoms. A cut-off score of 40 has demonstrated good sensitivity and specificity for identifying patients with central sensitization syndromes.
The Italian version of the CSI has shown good internal consistency (Cronbach's alpha = 0.87), ranging from 0.86 to 0.87 when individual items are removed.
Measured: T0 (baseline); T1 (7-weeks); T2 (6 months)
Pain Catastrophizing
The Pain Catastrophizing Scale (PCS) (13 items) is used to assess the level of catastrophizing thoughts associated with pain. Each item is rated on a 5-point Likert scale, from 0 ("not at all") to 4 ("all the time"). The total score ranges from 0 to 52, with higher scores indicating greater pain catastrophizing.
The Italian version of the PCS has demonstrated excellent internal consistency (Cronbach's alpha = 0.92) and test-retest reliability (ICC = 0.842, p < 0.001).
Measured: T0 (baseline); T1 (7-weeks); T2 (6 months)
Psychological Flexibility
The Multidimensional Psychological Flexibility Inventory (MPFI-24) is a self-report measure assessing all flexibility and inflexibility processes within the Hexaflex/Inflexahex model. Respondents rate how well each item reflects their experience over the past two weeks using a 6-point Likert scale from 1 ("Never true") to 6 ("Always true").
The Italian version of the MPFI has demonstrated excellent internal consistency (Cronbach's alpha = 0.94) for both overall psychological flexibility and inflexibility, with subscale alphas ranging from 0.85 to 0.94.
Measured: T0 (baseline); T1 (7-weeks); T2 (6 months)
Self-Efficacy
The Pain Self-Efficacy Questionnaire (PSEQ) (10 items) is used in both clinical and research contexts to assess individuals' confidence in performing activities despite pain. Each item is rated on a 7-point Likert scale, from 0 ("not at all confident") to 6 ("completely confident"). Total scores range from 0 to 60, with higher scores indicating greater pain-related self-efficacy.
The Italian version of the PSEQ has shown excellent internal consistency (Cronbach's alpha = 0.94) and good test-retest reliability (ICC = 0.82).
Measured: T0 (baseline); T1 (7-weeks); T2 (6 months)
Coping
The Chronic Pain Coping Inventory (CPCI-42) (42 items) asks patients to rate how often they used behavioral and cognitive coping strategies during the previous week. The Italian version, validated across cultures, maintains its eight-subscale structure, with each subscale producing a score from 0 to 7. Higher scores reflect more frequent use of coping strategies.
The Italian CPCI-42 has shown good internal consistency (Cronbach's alpha = 0.71-0.80) and reliability (ICC = 0.70-0.85, and >0.85 for all subscales).
Measured: T0 (baseline); T1 (7-weeks); T2 (6 months)
Anxiety
The Generalized Anxiety Disorder scale (GAD-7) (7 items) assesses symptoms of generalized anxiety. Respondents rate how often they have been bothered by each symptom over the past 14 days on a 4-point scale: 0 ("Not at all"), 1 ("Several days"), 2 ("More than half the days"), and 3 ("Nearly every day"). Total scores range from 0 to 21 and are interpreted as follows: 0-4 = minimal anxiety, 5-9 = mild anxiety, 10-14 = moderate anxiety, 15-21 = severe anxiety.
The Italian version of the GAD-7 has shown good internal consistency (Cronbach's alpha = 0.918) and test-retest reliability (ICC = 0.83).
Measured: T0 (baseline); T1 (7-weeks); T2 (6 months)
Depression
The Patient Health Questionnaire (PHQ-9) is a self-report measure used to assess the severity of depressive symptoms. The nine items correspond to the DSM-IV criteria for major depressive disorder and evaluate symptom frequency over the past two weeks. Items include: little interest or pleasure in doing things, feeling down or hopeless, sleep issues, fatigue, appetite changes, feelings of worthlessness, difficulty concentrating, psychomotor changes, and suicidal thoughts. Each item is scored from 0 ("Not at all") to 3 ("Nearly every day"), with total scores ranging from 0 to 27. Interpretation: 0-4 = minimal depression, 5-9 = mild, 10-14 = moderate, 15-19 = moderately severe, and 20-27 = severe depression.
The Italian version of the PHQ-9 has demonstrated good internal consistency (Cronbach's alpha = 0.918).
Measured: T0 (baseline); T1 (7-weeks); T2 (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start1 Oct 2025
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Collaborators
- Linkoeping University
- Responsible party
- Principal investigator, Gianluca Castelnuovo, Catholic University of the Sacred Heart
- Investigators
- Gianluca Castelnuovo, Ph.D., Principal investigator, Catholic University of Sacred Heart of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07270588
- Sponsor's protocol ID
- CUP J53D23008130008
- Acronym
- MobACT
- Status last verified
- Jul 2025
- First submitted
- 26 Sep 2025
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 29768436Vlaescu 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.
PubMed 30135819Sleed 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.
PubMed 16297552Scott 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.
PubMed 27397934Schutze 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.
PubMed 29122652Savoia 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.
PubMed 16901340Sanders 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.2016.12195.
PubMed 27623463Pietrabissa 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.
PubMed 38398481Perlini C, Donisi V, Rossetti MG, Moltrasio C, Bellani M, Brambilla P. The potential role of EMDR on trauma in affective disorders: A narrative review. J Affect Disord. 2020 May 15;269:1-11. doi: 10.1016/j.jad.2020.03.001. Epub 2020 Mar 14.
PubMed 32217337Pakenham KI, Landi G, Boccolini G, Furlani A, Grandi S, Tossani E. The moderating roles of psychological flexibility and inflexibility on the mental health impacts of COVID-19 pandemic and lockdown in Italy. J Contextual Behav Sci. 2020 Jul;17:109-118. doi: 10.1016/j.jcbs.2020.07.003. Epub 2020 Jul 20.
PubMed 32834969Nicholas M, Vlaeyen JWS, Rief W, Barke A, Aziz Q, Benoliel R, Cohen M, Evers S, Giamberardino MA, Goebel A, Korwisi B, Perrot S, Svensson P, Wang SJ, Treede RD; IASP Taskforce for the Classification of Chronic Pain. The IASP classification of chronic pain for ICD-11: chronic primary pain. Pain. 2019 Jan;160(1):28-37. doi: 10.1097/j.pain.0000000000001390.
PubMed 30586068Monticone M, Ferrante S, Rocca B, Nava T, Parini C, Cerri C. Chronic pain acceptance questionnaire: confirmatory factor analysis, reliability, and validity in Italian subjects with chronic low back pain. Spine (Phila Pa 1976). 2013 Jun 1;38(13):E824-31. doi: 10.1097/BRS.0b013e3182917299.
PubMed 23524871Monticone M, Baiardi P, Ferrari S, Foti C, Mugnai R, Pillastrini P, Rocca B, Vanti C. Development of the Italian version of the Pain Catastrophising Scale (PCS-I): cross-cultural adaptation, factor analysis, reliability, validity and sensitivity to change. Qual Life Res. 2012 Aug;21(6):1045-50. doi: 10.1007/s11136-011-0007-4. Epub 2011 Sep 13.
PubMed 21912846Macea DD, Gajos K, Daglia Calil YA, Fregni F. The efficacy of Web-based cognitive behavioral interventions for chronic pain: a systematic review and meta-analysis. J Pain. 2010 Oct;11(10):917-29. doi: 10.1016/j.jpain.2010.06.005. Epub 2010 Jul 22.
PubMed 20650691Lin J, Paganini S, Sander L, Luking M, Ebert DD, Buhrman M, Andersson G, Baumeister H. An Internet-Based Intervention for Chronic Pain. Dtsch Arztebl Int. 2017 Oct 13;114(41):681-688. doi: 10.3238/arztebl.2017.0681.
PubMed 29082858
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MOBACT: An Internet-Based Guided Self-Help Intervention Based on Acceptance and Commitment Therapy for Chronic Pain
- ClinicalTrials.gov ID
- NCT07270588
- Acronym / sponsor ID
- MobACT / CUP J53D23008130008
- Conditions
- Chronic Pain
- Keywords
- Chronic Pain, Internet-based intervention, clinical psychology, acceptance and commitment therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Collaborators
- Linkoeping University
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 8 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 7-weeks Internet-based interventions | Experimental | Other: Internet-based interventionParticipants 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 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- Current participation in psychological or psychotherapeutic treatments for chronic pain management;
- High risk of suicide;
- Cognitive impairments;
- Presence of certified psychiatric disorders, such as:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-based interventionParticipants 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 | 7-weeks Internet-based interventions |
Primary outcome
Chronic Pain Acceptance
Time frame: T0 (baseline); T1 (7-weeks); T2 (6 months)
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.
10 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
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- Background: PubMed 30135819Vlaescu 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.
- Background: PubMed 16297552Sleed 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.
- Background: PubMed 27397934Scott 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.
- Background: PubMed 29122652Schutze 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.
- Background: PubMed 16901340Savoia 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.
- Background: PubMed 27623463Sanders 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.2016.12195.
- Background: PubMed 38398481Pietrabissa 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.
- Background: PubMed 32217337Perlini C, Donisi V, Rossetti MG, Moltrasio C, Bellani M, Brambilla P. The potential role of EMDR on trauma in affective disorders: A narrative review. J Affect Disord. 2020 May 15;269:1-11. doi: 10.1016/j.jad.2020.03.001. Epub 2020 Mar 14.
- Background: PubMed 32834969Pakenham KI, Landi G, Boccolini G, Furlani A, Grandi S, Tossani E. The moderating roles of psychological flexibility and inflexibility on the mental health impacts of COVID-19 pandemic and lockdown in Italy. J Contextual Behav Sci. 2020 Jul;17:109-118. doi: 10.1016/j.jcbs.2020.07.003. Epub 2020 Jul 20.
- Background: PubMed 30586068Nicholas M, Vlaeyen JWS, Rief W, Barke A, Aziz Q, Benoliel R, Cohen M, Evers S, Giamberardino MA, Goebel A, Korwisi B, Perrot S, Svensson P, Wang SJ, Treede RD; IASP Taskforce for the Classification of Chronic Pain. The IASP classification of chronic pain for ICD-11: chronic primary pain. Pain. 2019 Jan;160(1):28-37. doi: 10.1097/j.pain.0000000000001390.
- Background: PubMed 23524871Monticone M, Ferrante S, Rocca B, Nava T, Parini C, Cerri C. Chronic pain acceptance questionnaire: confirmatory factor analysis, reliability, and validity in Italian subjects with chronic low back pain. Spine (Phila Pa 1976). 2013 Jun 1;38(13):E824-31. doi: 10.1097/BRS.0b013e3182917299.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Giada Pietrabissa contact
Gianluca Castelnuovo, Ph.D. principal investigator
Catholic University of Sacred Heart of Milan
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-based intervention in people with Chronic Pain, run by Catholic University of the Sacred Heart at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michelle Semonella (+972559876070, michelle.semonella@unicatt.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic Pain Acceptance (time frame: T0 (baseline); T1 (7-weeks); T2 (6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07270588, which also lists 34 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026; AzTrials last refreshed its copy on 31 Oct 2026.