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Background: Acceptance and commitment therapy (ACT) can be effective in treating chronic pain. Despite evidence supporting the effectiveness of ACT, uncertainties remain regarding which subgroups in the chronic pain population are likely to benefit most and least. This protocol describes the application for two meta-analytic approaches, one at the level of individual participant data and the other at the level of aggregated data, from randomized controlled trials of ACT for chronic pain (ACT-CP-MA)., Methods: We will systematically conduct literature searches in CENTRAL, MEDLINE, EMBASE, PsycINFO, and trial registers. Two reviewers will independently select studies for inclusion and data extraction. ACT-CP-MA will include randomized controlled trials with ACT for chronic pain compared to control conditions for adults (≥ 18 years) with chronic pain (> 3 months). We will invite the authors of all eligible trials to share individual participant data. Outcomes will include standardized measures of pain interference, pain intensity, depression, anxiety, health-related quality of life, participants' rating of overall improvement, and ACT-related process variables. Using the Cochrane Collaboration's tool and GRADE, reviewers will independently check for risk of bias, quality of evidence, and strength of recommendations. In the individual participant data meta-analysis, we will use a one-step approach where participants are clustered with studies and data from all studies are modeled simultaneously. For analyses, we will use mixed-effects models. Additionally, we will employ a meta-analysis with aggregate data and compare the results of both meta-analyses., Discussion: This collaborative meta-analysis of individual participant data from randomized controlled trials of ACT for chronic pain versus control conditions will demonstrate how the known benefits of ACT for chronic pain vary across different subtypes of the chronic pain population. The results of the meta-analyses will be based on a comprehensive search of multiple databases and will help to inform future clinical trials and decision-making on the use of ACT in chronic pain and improve the quality, design, and reporting of future trials in this field., Systematic Review Registration: PROSPERO CRD42019120901.

Objective: This study aims at evaluating the cost-effectiveness and cost-utility of a guided and unguided internet-based intervention for chronic pain patients (ACTonPain guided and ACTonPain unguided ) compared with a waitlist control group (CG) as well as the comparative cost-effectiveness of the guided and the unguided version., Design: This is a health economic evaluation alongside a three-arm randomised controlled trial from a societal perspective. Assessments were conducted at baseline, 9 weeks and 6 months after randomisation., Setting: Participants were recruited through online and offline strategies and in collaboration with a health insurance company., Participants: 302 adults (≥18 years, pain for at least 6 months) were randomly allocated to one of the three groups (ACTonPain guided , ACTonPain unguided , CG)., Interventions: ACTonPain consists of seven modules and is based on Acceptance and Commitment Therapy. ACTonPain guided and ACTonPain unguided only differ in provision of human support., Primary and Secondary Outcome Measures: Main outcomes of the cost-effectiveness and the cost-utility analyses were meaningful change in pain interference (treatment response) and quality-adjusted life years (QALYs), respectively. Economic evaluation estimates were the incremental cost-effectiveness and cost-utility ratio (ICER/ICUR)., Results: At 6-month follow-up, treatment response and QALYs were highest in ACTonPain guided (44% and 0.280; mean costs = €6,945), followed by ACTonPain unguided (28% and 0.266; mean costs = €6,560) and the CG (16% and 0.244; mean costs = €6,908). ACTonPain guided vs CG revealed an ICER of €45 and an ICUR of €604.ACTonPain unguided dominated CG. At a willingness-to-pay of €0 the probability of being cost-effective was 50% for ACTonPain guided (vs CG, for both treatment response and QALY gained) and 67% for ACTonPain unguided (vs CG, for both treatment response and QALY gained). These probabilities rose to 95% when society's willingness-to-pay is €91,000 (ACTonPain guided ) and €127,000 (ACTonPain unguided ) per QALY gained. ACTonPain guided vs ACTonPain unguided revealed an ICER of €2,374 and an ICUR of €45,993., Conclusions: Depending on society's willingness-to-pay, ACTonPain is a potentially cost-effective adjunct to established pain treatment. ACTonPain unguided (vs CG) revealed lower costs at better health outcomes. However, uncertainty has to be considered. Direct comparison of the two interventions does not indicate a preference for ACTonPain guided ., Trial Registration Number: DRKS00006183., Competing Interests: Competing interests: Two of the authors of the manuscript were involved in the development of ACTonPain (JL and HB). HB and DDE are consultants for several stakeholders (insurance companies, ministries, psychotherapy chambers, companies). DDE is part of the GET.ON Institut GmbH, which aims at implementing evidence-based internet-based and mobile based interventions into routine care. SP, CB, FK and DL declare that they have no competing interests., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

One way to improve treatment effects of chronic pain is to identify and improve control over mechanisms of therapeutic change. One treatment approach that includes a specific proposed mechanism is acceptance and commitment therapy (ACT) with its focus on increasing psychological flexibility (PF). The aim of the present study was to examine the role of PF as a mechanism of change in ACT. This is based on mediation analyses of data from a previously reported randomized controlled trial, evaluating the effectiveness of an ACT-based online intervention for chronic pain (ACTonPain). We performed secondary analyses on pretreatment, posttreatment, and follow-up data from 302 adults, receiving a guided (n = 100) or unguided (n = 101) version of ACTonPain, or allocated to the waitlist control group (n = 101). Structural equation modelling and a bias-corrected bootstrap approach were applied to examine the indirect effects of the treatment through pretreatment and posttreatment changes in the latent construct reflecting PF. The latent construct consisted of data from the Chronic Pain Acceptance Questionnaire and the Acceptance and Action Questionnaire. The outcomes were pretreatment to follow-up changes in pain interference, anxiety, depression, pain, and mental and physical health. Structural equation modelling analyses revealed that changes in PF significantly mediated pretreatment to follow-up changes in all outcomes in the intervention groups compared with waitlist (standardized estimates ranged from I0.16I to I0.69I). Global model fit yielded modest but acceptable results. Findings are consistent with the theoretical framework behind ACT and contribute to growing evidence, supporting a focus on PF to optimize treatment effects.

This study re-investigated data of a randomized controlled trial on Internet-based Acceptance and Commitment Therapy for chronic pain (ACTonPain). Baseline psychological inflexibility was examined as a moderator of the outcome pain interference. In the ACTonPain trial, participants with chronic pain were randomized to one of three conditions: guided Internet-based ACT (n = 100), unguided Internet-based ACT (n = 101), and waitlist (n = 101). Moderation analyses were performed with the SPSS macro PROCESS. Pain interference according to the Multidimensional Pain Inventory (MPI) was the primary outcome in this trial, and the potential moderator psychological inflexibility was measured with the Acceptance and Action Questionnaire (AAQ-II). Psychological inflexibility at baseline moderated the outcome between guided Internet-based ACT and waitlist 9-weeks as well as 6-months after randomization. (both p < 0.05). Between unguided Internet-based ACT and waitlist, psychological inflexibility moderated the outcome 6-months after randomization (p < 0.05). Internet-based ACT was superior to waitlist for participants with less psychological inflexibility at baseline, but Internet-based ACT became increasingly comparable to waitlist at higher AAQ-II baseline values. Future research should investigate whether the results can be replicated in more individualized and tailored face-to-face settings. [ABSTRACT FROM AUTHOR]

One way to improve treatment effects of chronic pain is to identify and improve control over mechanisms of therapeutic change. One treatment approach that includes a specific proposed mechanism is acceptance and commitment therapy (ACT) with its focus on increasing psychological flexibility (PF). The aim of the present study was to examine the role of PF as a mechanism of change in ACT. This is based on mediation analyses of data from a previously reported randomized controlled trial, evaluating the effectiveness of an ACT-based online intervention for chronic pain (ACTonPain). We performed secondary analyses on pretreatment, posttreatment, and follow-up data from 302 adults, receiving a guided (n = 100) or unguided (n = 101) version of ACTonPain, or allocated to the waitlist control group (n = 101). Structural equation modelling and a bias-corrected bootstrap approach were applied to examine the indirect effects of the treatment through pretreatment and posttreatment changes in the latent construct reflecting PF. The latent construct consisted of data from the Chronic Pain Acceptance Questionnaire and the Acceptance and Action Questionnaire. The outcomes were pretreatment to follow-up changes in pain interference, anxiety, depression, pain, and mental and physical health. Structural equation modelling analyses revealed that changes in PF significantly mediated pretreatment to follow-up changes in all outcomes in the intervention groups compared with waitlist (standardized estimates ranged from I0.16I to I0.69I). Global model fit yielded modest but acceptable results. Findings are consistent with the theoretical framework behind ACT and contribute to growing evidence, supporting a focus on PF to optimize treatment effects. [ABSTRACT FROM AUTHOR]