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Design considerations of a randomized clinical trial on a cognitive behavioural intervention using communication and information technologies for managing chronic low back pain.

ABSTRACT: Psychological treatments have been successful in treating chronic low back pain (CLBP). However, the effect sizes are still modest and there is room for improvement. A way to progress is by enhancing treatment adherence and self-management using information and communication technologies (ICTs). Therefore, the objective of this study was to design a trial investigating the short- and long-term efficacy of cognitive behavioural treatment (CBT) for CLBP using or not ICTs. A secondary objective of this trial will be to evaluate the influence of relevant variables on treatment response. Possible barriers in the implementation of CBT with and without ICT will also be investigated.A randomised controlled trial with 180 CLBP patients recruited from specialised care will be conducted. Participants will be randomly assigned to three conditions: Control group (CG), CBT, and CBT supported by ICTs (CBT + ICT). Participants belonging to the three conditions will receive a conventional rehabilitation program (back school). The CBT group program will last six sessions. The CBT + ICT group will use the internet and SMS to practice the therapeutic strategies between sessions and in the follow-ups at their homes. Primary outcome variables will be self-reported disability and pain intensity. Assessment will be carried out by blinded assessors in five moments: pre-treatment, post-treatment and 3-, 6-, and 12-month follow-ups. The influence of catastrophizing, fear-avoidance beliefs, anxiety and depression in response to treatment in the primary outcomes will also be analysed.This study will show data of the possible benefits of using ICTs in the improvement of CBT for treating CLBP.ClinicalTrials.gov, NCT01802671.

SUBMITTER: Domenech J

PROVIDER: S-EPMC3655937 | biostudies-literature | 2013 Apr

REPOSITORIES: biostudies-literature

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Design considerations of a randomized clinical trial on a cognitive behavioural intervention using communication and information technologies for managing chronic low back pain.

Domenech Julio J Baños Rosa R Peñalver Lourdes L Garcia-Palacios Azucena A Herrero Rocio R Ezzedine Aida A Martinez-Diaz Monica M Ballester Javier J Horta Jaime J Botella Cristina C

BMC musculoskeletal disorders 20130422

<h4>Background</h4>Psychological treatments have been successful in treating chronic low back pain (CLBP). However, the effect sizes are still modest and there is room for improvement. A way to progress is by enhancing treatment adherence and self-management using information and communication technologies (ICTs). Therefore, the objective of this study was to design a trial investigating the short- and long-term efficacy of cognitive behavioural treatment (CBT) for CLBP using or not ICTs. A seco ...[more]

PMID: 23607895

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Project description:Many interventions for the treatment of low back pain exist, but the mechanisms through which such treatments work are not always clear. This situation is especially true for biopsychosocial interventions that incorporate several different components and methods of delivery.The study objective was to examine the indirect effects of the Cognitive Patient Education (COPE) intervention via illness perceptions, back pain myths, and pain catastrophizing on disability outcome.This study was a secondary analysis of the COPE randomized controlled trial.Mediation analysis techniques were employed to examine the indirect effects of the COPE intervention via residualized change (baseline - posttreatment) in the 3 variables hypothesized to be targeted by the COPE intervention on posttreatment disability outcome. Pain intensity at baseline, pain duration, clinician type, and a treatment-mediator interaction term were controlled for in the analysis.Preliminary analyses confirmed that changes in pain catastrophizing and illness perceptions (not back pain myths) were related to both allocation to the intervention arm and posttreatment disability score. The treatment exerted statistically significant indirect effects via changes in illness perceptions and pain catastrophizing on posttreatment disability score (illness perceptions standardized indirect effect = 0.09 [95% CI = 0.03 to 0.16]; pain catastrophizing standardized indirect effect = 0.05 [95% CI = 0.01 to 0.12]). However, the inclusion of an interaction term led to the indirect effects being significantly reduced, with the effects no longer being statistically significant.This study presents a secondary analysis of variables not identified a priori as being potentially important treatment targets; other, unmeasured factors could also be important in explaining treatment effects.The finding that small indirect effects of the COPE intervention via changes in illness perceptions and pain catastrophizing on posttreatment disability could be estimated indicates that these variables may be viable treatment targets for biopsychosocial interventions; however, this finding must be viewed in light of the adjusted analyses, which showed that the indirect effects were significantly reduced through the inclusion of a treatment-mediator interaction term.

Project description:BackgroundThe instantaneous spread of information, low costs, and broad availability of information and communication technologies (ICTs) make them an attractive platform for managing care, patient communication, and medical interventions in cancer treatment. There is little information available in Latin America about the level of usage of ICTs for and by cancer patients. Our study attempts to fill this gap.ObjectiveThe aim of this study was to assess the level of ICT use and patterns of preferences among cancer patients.MethodsWe conducted an anonymous cross-sectional survey study in 500 Ecuadorian cancer patients. This questionnaire consisted of 22 items about demographic and clinical data, together with the preferences of people who use ICTs. Chi-square, crude, and adjusted logistic regressions were performed.ResultsOf the total, 43.2% (216/500) of participants reported that they had access to the Internet, and 25.4% (127/500) reported that they neither owned a cell phone nor did they have access to the Internet. The Internet constituted the highest usage rate as a source of information about malignant diseases (74.3%, 162/218) regardless of age (P<.001). With regard to the preferences on how patients would like to use ICTs to receive information about diseases, WhatsApp (66.5%, 145/218) and short message service (SMS) text messaging (61.0%, 133/218) were widely reported as interesting communication channels. Similarly, WhatsApp (72.0%, 157/218) followed by SMS (63.8%, 139/218) were reported as the preferred ICTs through which patients would like to ask physicians about diseases. Adjusted regression analysis showed that patients aged between 40 and 64 years were more likely to be interested in receiving information through SMS (odds ratio, OR 5.09, 95% CI 1.92-13.32), as well as for asking questions to physicians through this same media (OR 9.78, CI 3.45-27.67) than the oldest group.ConclusionsWhatsApp, SMS, and email are effective and widely used ICTs that can promote communication between cancer patients and physicians. According to age range, new ICTs such as Facebook are still emerging. Future studies should investigate how to develop and promote ICT-based resources more effectively to engage the outcomes of cancer patients. The widespread use of ICTs narrows the gap between cancer patients with restricted socioeconomic conditions and those with wealth and easily available technological means, thereby opening up new possibilities in low-income countries.

Project description:BackgroundDespite a surge in health information and communication technology (ICT), there is little evidence of lowered cost or increased quality of care. ICT may support patients, health care providers, and other stakeholders through complex rehabilitation trajectories by offering digital platforms for collaboration, shared decision-making, and safe storage of data. Yet, the questions on how ICT can become a useful tool and how the complex intersection between producers and users of ICT should be solved are challenging.ObjectiveThis study aims to review the literature on how ICTs are used to foster collaboration among the patient, the provider, and other stakeholders.MethodsThis scoping review follows the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) guidelines. Studies were identified by searching MEDLINE (OVID), Embase (OVID), CINAHL (EBSCOhost), AMED (EBSCOhost), and Scopus. Unpublished studies were extracted from OAIster, Bielefeld Academic Search Engine, ProQuest Dissertations and Theses, NARIC, and Google Scholar. Eligible papers addressed or described a remote dialogue between stakeholders using ICT to address goals and means, provide decision support, or evaluate certain treatment modalities within a rehabilitation context. Due to the rapid development of ICTs, searches included studies published in the period of 2018-2022.ResultsIn total, 3206 papers (excluding duplicates) were screened. Three papers met all inclusion criteria. The papers varied in design, key findings, and key challenges. These 3 studies reported outcomes such as improvements in activity performance, participation, frequency of leaving the house, improved self-efficacy, change in patients' perspective on possibilities, and change in professionals' understanding of patients' priorities. However, a misfit between the participants' needs and the technology offered, complexity and lack of availability of the technology, difficulties with implementation and uptake, and lack of flexibility in setup and maintenance reduced the value of ICT for those involved in the studies. The low number of included papers is probably due to the complexity of remote collaboration with ICT.ConclusionsICT has the potential to facilitate communication among stakeholders in the complex and collaborative context of rehabilitation trajectories. This scoping review indicates that there is a paucity of research considering remote ICT-supported collaboration in health care and rehabilitation trajectories. Furthermore, current ICT builds on eHealth literacy, which may differ among stakeholders, and the lack of sufficient eHealth literacy and ICT knowledge creates barriers for access to health care and rehabilitation. Lastly, the aim and results of this review are probably most relevant in high-income countries.

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Design considerations of a randomized clinical trial on a cognitive behavioural intervention using communication and information technologies for managing chronic low back pain.

Publications

Design considerations of a randomized clinical trial on a cognitive behavioural intervention using communication and information technologies for managing chronic low back pain.

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