MobACT: An Internet-Based Intervention for Chronic Pain Patients
ConditionChronic Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCatholic University of the Sacred Heart
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 years or older;
A verifiable medical diagnosis of Chronic Pain (duration ≥ 3 months);
Internet access;
Sufficient computer and internet literacy;
Disqualifiers
Current participation in psychological or psychotherapeutic treatments for chronic pain management;
High risk of suicide;
Cognitive impairments;
Psychotic disorders (e.g., schizophrenia, schizoaffective disorders, etc.);
Trial design
Design model
Parallel
Treatments tested in this trial
Internet-based intervention
Other 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.
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: 7-weeks Internet-based interventionsExperimental treatment 1 intervention
Group B: 7-Weeks Waiting listNo intervention 0 interventions
Trial outcomes
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.
Time frame
T0 (baseline); T1 (7-weeks); T2 (6 months)Secondary outcomes
1
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).
Time frame
T0 (baseline); T1 (7-weeks); T2 (6 months)2
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.
Time frame
T0 (baseline); T1 (7-weeks); T2 (6 months)3
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.
Time frame
T0 (baseline); T1 (7-weeks); T2 (6 months)4
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.
Time frame
T0 (baseline); T1 (7-weeks); T2 (6 months)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Catholic University of the Sacred Heart
Lead sponsor
Linkoeping University
Collaborator
Source ClinicalTrials.gov