NCT04200183

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

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
246

participants targeted

Target at P75+ for not_applicable chronic-pain

Timeline
Completed

Started Feb 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 16, 2019

Completed
1.1 years until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2022

Completed
Last Updated

June 11, 2020

Status Verified

June 1, 2020

Enrollment Period

11 months

First QC Date

September 18, 2019

Last Update Submit

June 8, 2020

Conditions

Keywords

chronic paincontextual behavioral interventionacceptance and commitment therapymindfulnesscompassion-based therapyonline intervention

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

EXPERIMENTAL
Behavioral: iACTwithPain (ACT+compassion)

ACT-only intervention

EXPERIMENTAL
Behavioral: ACT-only intervention

Wait list (inactive control)

NO INTERVENTION

Interventions

This intervention will deliver a eHealth ACT and compassion-based therapy (iACTwithPain) designed for chronic pain

iACTwithPain

This intervention will deliver the iACTwithPain intervention but without the delivery of explicit compassion.

ACT-only intervention

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

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.

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

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