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Efficacy of an ACT and Compassion-Based eHealth Program for Self-Management of Chronic Pain (iACTwithPain) : Study Protocol for a Randomized Controlled Trial

Carvalho, Sérgio A. ; Trindade, Inês A. ; Duarte, Joana LU ; Menezes, Paulo ; Patrão, Bruno ; Nogueira, Maria Rita ; Guiomar, Raquel ; Lapa, Teresa ; Pinto-Gouveia, José and Castilho, Paula (2021) In Frontiers in Psychology 12.
Abstract

Background: Chronic pain (CP) has serious medical and social consequences and leads to economic burden that threatens the sustainability of healthcare services. Thus, optimized management of pain tools to support CP patients in adjusting to their condition and improving their quality of life is timely. Although acceptance and commitment therapy (ACT) is considered an evidence-based psychological approach for CP, evidence for the efficacy of online-delivered ACT for CP is still scarce. At the same time, studies suggest that self-compassion mediates 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... (More)

Background: Chronic pain (CP) has serious medical and social consequences and leads to economic burden that threatens the sustainability of healthcare services. Thus, optimized management of pain tools to support CP patients in adjusting to their condition and improving their quality of life is timely. Although acceptance and commitment therapy (ACT) is considered an evidence-based psychological approach for CP, evidence for the efficacy of online-delivered ACT for CP is still scarce. At the same time, studies suggest that self-compassion mediates 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 for CP, although this hypothesis has not been tested. This study aims to develop an eHealth ACT and compassion-based self-management intervention for CP, the iACTwithPain, and to compare its efficacy in improving health outcomes to a similar ACT-only intervention and a medical TAU group. Methods: The eHealth platform that will host the interventions will be developed using a flat design identity and will be interactive. The iACTwithPain intervention will comprise eight weekly self-management sessions and will be developed taking into consideration the psychological flexibility model applied to CP, with the addition of explicit compassion-based components. To analyze whether the iACTwithPain intervention will present superiority in improving CP’s impact and related health markers over the two other conditions, this study will follow an RCT design with three arms. CP patients will be recruited through direct contact with patient associations and healthcare services and a national press release in Portugal. Outcome measurement will be conducted at baseline, post-intervention and at 3- and 6-month follow-ups. The interventions’ acceptability will also be assessed. Discussion: The iACTwithPain intervention is expected to improve CP patients’ psychosocial functioning, quality of life, and empowerment, by promoting adaptive disease management and regulation of pain-related internal experiences. Results will contribute to a better understanding on the pertinence of adding compassion elements to ACT for CP and to reach an optimized intervention for CP. Clinical Trial Registration: This trial has been registered at ClinicalTrials.Gov (NCT04200183; 16 December 2019; https://clinicaltrials.gov/ct2/show/NCT04200183). The current manuscript comprises the first version of this clinical trial’s protocol.

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type
Contribution to journal
publication status
published
subject
keywords
acceptance and commitment therapy, chronic pain, compassion-based intervention, eHealth, ICT-delivered interventions, mindfulness, self-management
in
Frontiers in Psychology
volume
12
article number
630766
publisher
Frontiers Media S. A.
external identifiers
  • scopus:85102956564
  • pmid:33767648
ISSN
1664-1078
DOI
10.3389/fpsyg.2021.630766
language
English
LU publication?
yes
id
3cdbd1c9-153c-4c3e-ba8e-1861e65ddddc
date added to LUP
2021-03-31 09:04:24
date last changed
2024-06-15 09:03:35
@article{3cdbd1c9-153c-4c3e-ba8e-1861e65ddddc,
  abstract     = {{<p>Background: Chronic pain (CP) has serious medical and social consequences and leads to economic burden that threatens the sustainability of healthcare services. Thus, optimized management of pain tools to support CP patients in adjusting to their condition and improving their quality of life is timely. Although acceptance and commitment therapy (ACT) is considered an evidence-based psychological approach for CP, evidence for the efficacy of online-delivered ACT for CP is still scarce. At the same time, studies suggest that self-compassion mediates 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 for CP, although this hypothesis has not been tested. This study aims to develop an eHealth ACT and compassion-based self-management intervention for CP, the iACTwithPain, and to compare its efficacy in improving health outcomes to a similar ACT-only intervention and a medical TAU group. Methods: The eHealth platform that will host the interventions will be developed using a flat design identity and will be interactive. The iACTwithPain intervention will comprise eight weekly self-management sessions and will be developed taking into consideration the psychological flexibility model applied to CP, with the addition of explicit compassion-based components. To analyze whether the iACTwithPain intervention will present superiority in improving CP’s impact and related health markers over the two other conditions, this study will follow an RCT design with three arms. CP patients will be recruited through direct contact with patient associations and healthcare services and a national press release in Portugal. Outcome measurement will be conducted at baseline, post-intervention and at 3- and 6-month follow-ups. The interventions’ acceptability will also be assessed. Discussion: The iACTwithPain intervention is expected to improve CP patients’ psychosocial functioning, quality of life, and empowerment, by promoting adaptive disease management and regulation of pain-related internal experiences. Results will contribute to a better understanding on the pertinence of adding compassion elements to ACT for CP and to reach an optimized intervention for CP. Clinical Trial Registration: This trial has been registered at ClinicalTrials.Gov (NCT04200183; 16 December 2019; https://clinicaltrials.gov/ct2/show/NCT04200183). The current manuscript comprises the first version of this clinical trial’s protocol.</p>}},
  author       = {{Carvalho, Sérgio A. and Trindade, Inês A. and Duarte, Joana and Menezes, Paulo and Patrão, Bruno and Nogueira, Maria Rita and Guiomar, Raquel and Lapa, Teresa and Pinto-Gouveia, José and Castilho, Paula}},
  issn         = {{1664-1078}},
  keywords     = {{acceptance and commitment therapy; chronic pain; compassion-based intervention; eHealth; ICT-delivered interventions; mindfulness; self-management}},
  language     = {{eng}},
  publisher    = {{Frontiers Media S. A.}},
  series       = {{Frontiers in Psychology}},
  title        = {{Efficacy of an ACT and Compassion-Based eHealth Program for Self-Management of Chronic Pain (iACTwithPain) : Study Protocol for a Randomized Controlled Trial}},
  url          = {{http://dx.doi.org/10.3389/fpsyg.2021.630766}},
  doi          = {{10.3389/fpsyg.2021.630766}},
  volume       = {{12}},
  year         = {{2021}},
}