iACT With Pain: an ICT-delivered Intervention for Self-management of Chronic Pain
iACT
1 other identifier
interventional
246
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable chronic-pain
Started Feb 2021
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 18, 2019
CompletedFirst Posted
Study publicly available on registry
December 16, 2019
CompletedStudy Start
First participant enrolled
February 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2022
CompletedJune 11, 2020
June 1, 2020
11 months
September 18, 2019
June 8, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
baseline, 8 weeks, 3 months, 6 months
Study Arms (3)
iACTwithPain
EXPERIMENTALACT-only intervention
EXPERIMENTALWait list (inactive control)
NO INTERVENTIONInterventions
This intervention will deliver a eHealth ACT and compassion-based therapy (iACTwithPain) designed for chronic pain
This intervention will deliver the iACTwithPain intervention but without the delivery of explicit compassion.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Coimbralead
- Fundação para a Ciência e a Tecnologiacollaborator
Related Publications (1)
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.
PMID: 33767648DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
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
- Assistant Professor
Study Record Dates
First Submitted
September 18, 2019
First Posted
December 16, 2019
Study Start
February 1, 2021
Primary Completion
December 30, 2021
Study Completion
March 30, 2022
Last Updated
June 11, 2020
Record last verified: 2020-06