Efficacy, cost-utility and physiological effects of Acceptance and Commitment Therapy (ACT) and Behavioural Activation Treatment for Depression (BATD) in patients with chronic low back pain and depression: study protocol of a randomised, controlled trial including mobile-technology-based ecological momentary assessment (IMPACT study)

Abstract

IntroductionThe IMPACT study focuses on chronic low back pain (CLBP) and depression symptoms, a prevalent and complex problem that represents a challenge for health professionals. Acceptance and Commitment Therapy (ACT) and Brief Behavioural Activation Treatment for Depression (BATD) are effective treatments for patients with persistent pain and depression, respectively. The objectives of this 12 month, multicentre, randomised, controlled trial (RCT) are (i) to examine the efficacy and cost-utility of adding a group-based form of ACT or BATD to treatment-as-usual (TAU) for patients with CLBP and moderate to severe levels of depressive symptoms; (ii) identify pre–post differences in levels of some physiological variables and (iii) analyse the role of polymorphisms in the FKBP5 gene, psychological process measures and physiological variables as mediators or moderators of long-term clinical changes.Methods and analysisParticipants will be 225 patients with CLBP and moderate to severe depression symptoms recruited at Parc Sanitari Sant Joan de Déu (St. Boi de Llobregat, Spain) and Hospital del Mar (Barcelona, Spain), randomly allocated to one of the three study arms: TAU vs TAU+ACT versus TAU+BATD. A comprehensive assessment to collect clinical variables and costs will be conducted pretreatment, post-treatment and at 12 months follow-up, being pain interference the primary outcome measure. The following physiological variables will be considered at pretreatment and post-treatment assessments in 50% of the sample: immune-inflammatory markers, hair cortisol and cortisone, serum cortisol, corticosteroid-binding globulin and vitamin D. Polymorphisms in the FKBP5 gene (rs3800373, rs9296158, rs1360780, rs9470080 and rs4713916) will be analysed at baseline assessment. Moreover, we will include mobile-technology-based ecological momentary assessment, through the Pain Monitor app, to track ongoing clinical status during ACT and BATD treatments. Linear mixed-effects models using restricted maximum likelihood, and a full economic evaluation applying bootstrapping techniques, acceptability curves and sensitivity analyses will be computed.Ethics and disseminationThis study has been approved by the Ethics Committee of the Fundació Sant Joan de Déu and Hospital del Mar. The results will be actively disseminated through peer-reviewed journals, conference presentations, social media and various community engagement activities.Trial registration numberNCT04140838

New generation psychological treatments in chronic pain

“…Emerging trends in psychological treatments for chronic pain include attempts to design treatments based on the most effective component methods, 69 or they focus on comorbid conditions associated with chronic pain. For the latter, the focus is on behavioral activation for depression in the context of chronic pain, 70 a combination of ACT plus mindfulness based prevention of relapse in problematic opioid use, 49 or the addition of prolonged exposure to traumatic reminders for people with chronic pain and post-traumatic stress disorder (PTSD). 71 The clinical trial for the study focused on depression is registered and recruitment has started (ClinicalTrials.gov, NCT04140838).…”

“…The assessment of processes of interest is likely to include physiological variables or biomarkers as a supplement to self-report 708586. Particularly for research related to psychological flexibility and processes of change, a wide range of dimensions is important, including genetic, epigenetic, neurobiological, immune, and others, in part because these can be assessed with relative precision and are known to correlate with the psychological processes or interest, but also because these can help integrate behavioral science with other health related sciences 87…”

Use of behavioural activation to manage pain: a systematic scoping review

“…However, larger, more robust trials are required. We did identify one study protocol 57 for an RCT that may contribute to a growing body of knowledge. Comparing three treatment groups (TAU, TAU with ACT, TAU with BA), with pain as a primary outcome measure, patients with chronic low back pain and moderate to severe depression will participate in the study with measures taken pretreatment, post-treatment and 1 year later.…”

Aplicaciones móviles en español para evaluación e intervención en Salud Mental: Una revisión sistemática

“…Esta aplicación se incluye ya como instrumento de evaluación en futuros trabajos ya protocolizados (Sanabria-Mazo et al, 2020). Bonet et al (2020) presentan los resultados de la implementación de RemindCare, una aplicación para el tratamiento de la psicosis, durante 19 meses en un total de 90 pacientes.…”