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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)
- Source :
- Dipòsit Digital de la UB, Universidad de Barcelona, BMJ Open, r-FSJD: Repositorio Institucional de Producción Científica de la Fundació Sant Joan de Déu, instname, r-FSJD. Repositorio Institucional de Producción Científica de la Fundació Sant Joan de Déu, Dipòsit Digital de Documents de la UAB, Universitat Autònoma de Barcelona, BMJ Open, Vol 10, Iss 7 (2020), Repositori Universitat Jaume I, Universitat Jaume I
- Publication Year :
- 2020
- Publisher :
- BMJ Publishing Group, 2020.
-
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
- Subjects :
- Technology
General Practice
lcsh:Medicine
Impact study
Chronic pain
R Medicine (General)
Acceptance and commitment therapy
law.invention
Clinical trials
Randomized controlled trial
Terapia de aceptación y compromiso
law
Depresión
Tratamiento breve de activación conductual para la depresión
Dolor persistente
Persistent pain
Medicine
Multicenter Studies as Topic
Depressió psíquica
Depression (differential diagnoses)
Applied Psychology
Randomized Controlled Trials as Topic
Ecology
Depression
Teràpia racional emotiva conductual
General Medicine
Dolor crònic
Chronic low back pain
Mental depression
Rational emotive behavior therapy
BF Psychology
Ecological Momentary Assessment
Clinical trials, Depression & mood disorders, pain management
Brief behavioral activation treatment for depression
159.9
Health Economics
Dolor lumbar crónico
Humans
Tractament breu d’activació conductual per a la depressió
Acceptance and Commitment Therapy
Protocol (science)
Dolor lumbar crònic
business.industry
lcsh:R
Teràpia d’acceptació i compromís
Dolor persistent
Tillämpad psykologi
Pain management
Clinical trial
Allmänmedicin
pain management
Spain
Depression & mood disorders
Economic evaluation
Depressió
business
Low Back Pain
Subjects
Details
- Language :
- English
- ISSN :
- 20446055
- Database :
- OpenAIRE
- Journal :
- Dipòsit Digital de la UB, Universidad de Barcelona, BMJ Open, r-FSJD: Repositorio Institucional de Producción Científica de la Fundació Sant Joan de Déu, instname, r-FSJD. Repositorio Institucional de Producción Científica de la Fundació Sant Joan de Déu, Dipòsit Digital de Documents de la UAB, Universitat Autònoma de Barcelona, BMJ Open, Vol 10, Iss 7 (2020), Repositori Universitat Jaume I, Universitat Jaume I
- Accession number :
- edsair.doi.dedup.....ebeceaf0dfc8833107b4e4e124a0f945