iACT With Pain: an ICT-delivered Intervention for Self-management of Chronic Pain (iACT)
Primary Purpose
Chronic Pain
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
iACTwithPain (ACT+compassion)
ACT-only intervention
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring chronic pain, contextual behavioral intervention, acceptance and commitment therapy, mindfulness, compassion-based therapy, online intervention
Eligibility Criteria
Inclusion Criteria:
- age 18 to 50;
- a CP diagnosis at least for the last three months;
- access to internet and willingness to do it regularly (at least once a week)
- willingness to be randomized
- provide informed consent.
Exclusion Criteria:
- undergoing any other form of psychological intervention for CP;
- severe psychiatric problem (e.g. severe depression; psychotic illness; bipolar disorder; borderline personality disorder), assessed using several questions (self-reported) based on the diagnostic criteria according to DSM-V;
- pain due to malignancy, trauma, or surgery.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
iACTwithPain
ACT-only intervention
Wait list (inactive control)
Arm Description
Outcomes
Primary Outcome Measures
Pain impact.
The 6-item Pain Impact Questionnaire (PIQ-6 (52,53) ) will be used to assess participants' perceived pain severity (1 item rated on a 6-point scale) and impact on emotional well-being, leisure activities, and work functioning (5 items rated on a 5-point scale).
Secondary Outcome Measures
Full Information
NCT ID
NCT04200183
First Posted
September 18, 2019
Last Updated
June 8, 2020
Sponsor
University of Coimbra
Collaborators
Fundação para a Ciência e a Tecnologia
1. Study Identification
Unique Protocol Identification Number
NCT04200183
Brief Title
iACT With Pain: an ICT-delivered Intervention for Self-management of Chronic Pain
Acronym
iACT
Official Title
iACT With Pain: an ICT-delivered Intervention for Self-management of Chronic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2021 (Anticipated)
Primary Completion Date
December 30, 2021 (Anticipated)
Study Completion Date
March 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Coimbra
Collaborators
Fundação para a Ciência e a Tecnologia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This project aims to test the effectiveness of an ICT-based delivery of an evidencebased psychological intervention for Chronic Pain (CP) - iACTwithPain. CP is a prevalent health problem worldwide, including in Portugal (around 30% of population) placing a significant economic burden on healthcare systems. Although CP is associated with psychological symptoms (i.e. depression and anxiety) and poor social functioning and quality of life, there is a lack of nationwide provision of evidence-based psychological services in healthcare units for CP. Information and Communication Technologies (ICTs) offer attractive tools through which self-management programmes can be delivered. The dissemination and commercialization of iACTwithPain will provide a much-needed pain self-management service and its ICT-based delivery form will increase the accessibility in large cohorts of the population with limited access to standard treatment.
Detailed Description
This project aims to develop and deliver an ICT self-management intervention for chronic pain (CP)-iACT. As persistent pain of different etiologies represents a medical, social and economic burden, optimized management of pain tools to support CP patients in adjusting to their condition and improving quality of life is timely and can lead to more costeffective healthcare systems by promoting the management of CP outside health institutions.
While CP influences and is influenced by psychological factors, provision of care to CP patients in Portugal vastly disregards psychological interventions. In contrast, the usual treatment to CP in Portugal is primarily pharmacologic, which has limited effects. Psychological interventions are well suited for addressing the cognitive, emotional and behavioral factors that contribute to and result from pain-related distress. Acceptance and Commitment Therapy(ACT) is an evidence-based psychological approach for CP. ACT focuses on fostering acceptance of the unavoidable aspects of pain and directing efforts towards behavioral functioning, rather than the traditional focus on controlling pain, which disregards the patient's overall functioning and well-being.
Also, studies suggest that self-compassion mediate the change in disability and psychopathological symptoms in ACT interventions for CP, although self-compassion is not a specific target in ACT. Thus, an explicit focus on self-compassion might increase the efficacy of ACT interventions, although this hypothesis has not been tested.
Online interventions have several advantages: reducing therapist time and waiting lists, increased cost-effectiveness, patients working at their own pace, accessibility to large clinical samples and rural and remote clinical cohorts.
However, evidence for the effectiveness of online-delivered ACT for CP is still scarce, with only three studies with several methodological limitations (i.e. small sample size and non-randomization). The innovative features of the current project are:1)the development of an ICT solution for self-management of pain, and improvement of overall well-being tailored to CP patients;2) the improvement of an ACT intervention by including psychological symptoms, and the increase in overall functioning and quality of life of CP patients; b)adding a new component(self-compassion) to the intervention will increase its effectiveness;c) its format will be a cost-effective solution for self-management of CP. The research strategy to achieve the project's goals follows a randomized controlled trial design with three arms: 1.iACTwithPain intervention (ACT + self-compassion); 2. ACT-only intervention; 3.Waiting List. iACTwithPain may also impact on other spheres of patients' lives such as work (e.g.,less absenteeism) and social (e.g.,less restrictions for leisure activities), which will contribute to more social inclusion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
chronic pain, contextual behavioral intervention, acceptance and commitment therapy, mindfulness, compassion-based therapy, online intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
246 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
iACTwithPain
Arm Type
Experimental
Arm Title
ACT-only intervention
Arm Type
Experimental
Arm Title
Wait list (inactive control)
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
iACTwithPain (ACT+compassion)
Intervention Description
This intervention will deliver a eHealth ACT and compassion-based therapy (iACTwithPain) designed for chronic pain
Intervention Type
Behavioral
Intervention Name(s)
ACT-only intervention
Intervention Description
This intervention will deliver the iACTwithPain intervention but without the delivery of explicit compassion.
Primary Outcome Measure Information:
Title
Pain impact.
Description
The 6-item Pain Impact Questionnaire (PIQ-6 (52,53) ) will be used to assess participants' perceived pain severity (1 item rated on a 6-point scale) and impact on emotional well-being, leisure activities, and work functioning (5 items rated on a 5-point scale).
Time Frame
baseline, 8 weeks, 3 months, 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age 18 to 50;
a CP diagnosis at least for the last three months;
access to internet and willingness to do it regularly (at least once a week)
willingness to be randomized
provide informed consent.
Exclusion Criteria:
undergoing any other form of psychological intervention for CP;
severe psychiatric problem (e.g. severe depression; psychotic illness; bipolar disorder; borderline personality disorder), assessed using several questions (self-reported) based on the diagnostic criteria according to DSM-V;
pain due to malignancy, trauma, or surgery.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paula Castilho, PhD
Phone
239 851 450
Ext
375
Email
paulacastilhofreitas@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33767648
Citation
Carvalho SA, Trindade IA, Duarte J, Menezes P, Patrao B, Nogueira MR, Guiomar R, Lapa T, Pinto-Gouveia J, Castilho P. Efficacy of an ACT and Compassion-Based eHealth Program for Self-Management of Chronic Pain (iACTwithPain): Study Protocol for a Randomized Controlled Trial. Front Psychol. 2021 Mar 9;12:630766. doi: 10.3389/fpsyg.2021.630766. eCollection 2021.
Results Reference
derived
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iACT With Pain: an ICT-delivered Intervention for Self-management of Chronic Pain
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