Clinical and cost-effectiveness of a guided internet-based Acceptance and Commitment Therapy to improve chronic pain–related disability in green professions (PACT-A): study protocol of a pragmatic randomised controlled trial
Introduction Chronic pain is highly prevalent, associated with substantial personal and economic burdens, and increased risk for mental disorders. Individuals in green professions (agriculturists, horticulturists, foresters) show increased prevalence of chronic pain and other risk factors for mental...
| Main Authors: | , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2020-09-01
|
| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/10/9/e034271.full |
| _version_ | 1818671921664884736 |
|---|---|
| author | Claudia Buntrock Yannik Terhorst Lina Braun Ingrid Titzler Johanna Freund Janika Thielecke David Ebert |
| author_facet | Claudia Buntrock Yannik Terhorst Lina Braun Ingrid Titzler Johanna Freund Janika Thielecke David Ebert |
| author_sort | Claudia Buntrock |
| collection | DOAJ |
| description | Introduction Chronic pain is highly prevalent, associated with substantial personal and economic burdens, and increased risk for mental disorders. Individuals in green professions (agriculturists, horticulturists, foresters) show increased prevalence of chronic pain and other risk factors for mental disorders. Available healthcare services in rural areas are limited. Acceptance towards face-to-face therapy is low. Internet and mobile-based interventions (IMIs) based on Acceptance and Commitment Therapy (ACT) might be a promising alternative for this population and may enable effective treatment of chronic pain. The present study aims to evaluate the clinical and cost-effectiveness of an ACT-based IMI for chronic pain in green professions in comparison with enhanced treatment as usual (TAU+).Methods and analysis A two-armed pragmatic randomised controlled trial will be conducted. Two hundred eighty-six participants will be randomised and allocated to either an intervention or TAU+ group. Entrepreneurs in green professions, collaborating spouses, family members and pensioners with chronic pain are eligible for inclusion. The intervention group receives an internet-based intervention based on ACT (7 modules, over 7 weeks) guided by a trained e-coach to support adherence (eg, by positive reinforcement). Primary outcome is pain interference (Multidimensional Pain Interference scale; MPI) at 9 weeks post-randomisation. Secondary outcomes are depression severity (Quick Inventory Depressive Symptomology; QIDS-SR16), incidence of major depressive disorder, quality of life (Assessment of Quality of Life; AQoL-8D) and possible side effects associated with the treatment (Inventory for the Assessment of Negative Effects of Psychotherapy; INEP). Psychological flexibility (Chronic Pain Acceptance Questionnaire, Committed Action Questionnaire, Cognitive Fusion Questionnaire) will be evaluated as a potential mediator of the treatment effect. Furthermore, mediation, moderation and health-economic analyses from a societal perspective will be performed. Outcomes will be measured using online self-report questionnaires at baseline, 9-week, 6-month, 12-month, 24-month and 36-month follow-ups.Ethics and dissemination This study was approved by the Ethics Committee of the University of Ulm, Germany (file no. 453/17—FSt/Sta; 22 February 2018). Results will be submitted for publication in peer-reviewed journals and presented at conferences.Trial registration number German Clinical Trial Registration: DRKS00014619. Registered on 16 April 2018. |
| first_indexed | 2024-12-17T07:31:41Z |
| format | Article |
| id | doaj.art-5292363e0c1746e8b6b5b1c7af5faa15 |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-12-17T07:31:41Z |
| publishDate | 2020-09-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-5292363e0c1746e8b6b5b1c7af5faa152022-12-21T21:58:28ZengBMJ Publishing GroupBMJ Open2044-60552020-09-0110910.1136/bmjopen-2019-034271Clinical and cost-effectiveness of a guided internet-based Acceptance and Commitment Therapy to improve chronic pain–related disability in green professions (PACT-A): study protocol of a pragmatic randomised controlled trialClaudia Buntrock0Yannik Terhorst1Lina Braun2Ingrid Titzler3Johanna Freund4Janika Thielecke5David Ebert6Clinical Psychology and Psychotherapy, Friedrich-Alexander University Erlangen-Nürnberg, Erlangen, Bayern, GermanyResearch Methods, Ulm University, Ulm, Baden-Württemberg, GermanyClinical Psychology and Psychotherapy, Ulm University, Ulm, Baden-Württemberg, GermanyClinical Psychology and Psychotherapy, Friedrich-Alexander University Erlangen-Nürnberg, Erlangen, Bayern, GermanyClinical Psychology and Psychotherapy, Friedrich-Alexander University Erlangen-Nürnberg, Erlangen, Bayern, GermanyClinical Psychology and Psychotherapy, Friedrich-Alexander University Erlangen-Nürnberg, Erlangen, Bayern, GermanyGET.ON Institute, Hamburg, GermanyIntroduction Chronic pain is highly prevalent, associated with substantial personal and economic burdens, and increased risk for mental disorders. Individuals in green professions (agriculturists, horticulturists, foresters) show increased prevalence of chronic pain and other risk factors for mental disorders. Available healthcare services in rural areas are limited. Acceptance towards face-to-face therapy is low. Internet and mobile-based interventions (IMIs) based on Acceptance and Commitment Therapy (ACT) might be a promising alternative for this population and may enable effective treatment of chronic pain. The present study aims to evaluate the clinical and cost-effectiveness of an ACT-based IMI for chronic pain in green professions in comparison with enhanced treatment as usual (TAU+).Methods and analysis A two-armed pragmatic randomised controlled trial will be conducted. Two hundred eighty-six participants will be randomised and allocated to either an intervention or TAU+ group. Entrepreneurs in green professions, collaborating spouses, family members and pensioners with chronic pain are eligible for inclusion. The intervention group receives an internet-based intervention based on ACT (7 modules, over 7 weeks) guided by a trained e-coach to support adherence (eg, by positive reinforcement). Primary outcome is pain interference (Multidimensional Pain Interference scale; MPI) at 9 weeks post-randomisation. Secondary outcomes are depression severity (Quick Inventory Depressive Symptomology; QIDS-SR16), incidence of major depressive disorder, quality of life (Assessment of Quality of Life; AQoL-8D) and possible side effects associated with the treatment (Inventory for the Assessment of Negative Effects of Psychotherapy; INEP). Psychological flexibility (Chronic Pain Acceptance Questionnaire, Committed Action Questionnaire, Cognitive Fusion Questionnaire) will be evaluated as a potential mediator of the treatment effect. Furthermore, mediation, moderation and health-economic analyses from a societal perspective will be performed. Outcomes will be measured using online self-report questionnaires at baseline, 9-week, 6-month, 12-month, 24-month and 36-month follow-ups.Ethics and dissemination This study was approved by the Ethics Committee of the University of Ulm, Germany (file no. 453/17—FSt/Sta; 22 February 2018). Results will be submitted for publication in peer-reviewed journals and presented at conferences.Trial registration number German Clinical Trial Registration: DRKS00014619. Registered on 16 April 2018.https://bmjopen.bmj.com/content/10/9/e034271.full |
| spellingShingle | Claudia Buntrock Yannik Terhorst Lina Braun Ingrid Titzler Johanna Freund Janika Thielecke David Ebert Clinical and cost-effectiveness of a guided internet-based Acceptance and Commitment Therapy to improve chronic pain–related disability in green professions (PACT-A): study protocol of a pragmatic randomised controlled trial BMJ Open |
| title | Clinical and cost-effectiveness of a guided internet-based Acceptance and Commitment Therapy to improve chronic pain–related disability in green professions (PACT-A): study protocol of a pragmatic randomised controlled trial |
| title_full | Clinical and cost-effectiveness of a guided internet-based Acceptance and Commitment Therapy to improve chronic pain–related disability in green professions (PACT-A): study protocol of a pragmatic randomised controlled trial |
| title_fullStr | Clinical and cost-effectiveness of a guided internet-based Acceptance and Commitment Therapy to improve chronic pain–related disability in green professions (PACT-A): study protocol of a pragmatic randomised controlled trial |
| title_full_unstemmed | Clinical and cost-effectiveness of a guided internet-based Acceptance and Commitment Therapy to improve chronic pain–related disability in green professions (PACT-A): study protocol of a pragmatic randomised controlled trial |
| title_short | Clinical and cost-effectiveness of a guided internet-based Acceptance and Commitment Therapy to improve chronic pain–related disability in green professions (PACT-A): study protocol of a pragmatic randomised controlled trial |
| title_sort | clinical and cost effectiveness of a guided internet based acceptance and commitment therapy to improve chronic pain related disability in green professions pact a study protocol of a pragmatic randomised controlled trial |
| url | https://bmjopen.bmj.com/content/10/9/e034271.full |
| work_keys_str_mv | AT claudiabuntrock clinicalandcosteffectivenessofaguidedinternetbasedacceptanceandcommitmenttherapytoimprovechronicpainrelateddisabilityingreenprofessionspactastudyprotocolofapragmaticrandomisedcontrolledtrial AT yannikterhorst clinicalandcosteffectivenessofaguidedinternetbasedacceptanceandcommitmenttherapytoimprovechronicpainrelateddisabilityingreenprofessionspactastudyprotocolofapragmaticrandomisedcontrolledtrial AT linabraun clinicalandcosteffectivenessofaguidedinternetbasedacceptanceandcommitmenttherapytoimprovechronicpainrelateddisabilityingreenprofessionspactastudyprotocolofapragmaticrandomisedcontrolledtrial AT ingridtitzler clinicalandcosteffectivenessofaguidedinternetbasedacceptanceandcommitmenttherapytoimprovechronicpainrelateddisabilityingreenprofessionspactastudyprotocolofapragmaticrandomisedcontrolledtrial AT johannafreund clinicalandcosteffectivenessofaguidedinternetbasedacceptanceandcommitmenttherapytoimprovechronicpainrelateddisabilityingreenprofessionspactastudyprotocolofapragmaticrandomisedcontrolledtrial AT janikathielecke clinicalandcosteffectivenessofaguidedinternetbasedacceptanceandcommitmenttherapytoimprovechronicpainrelateddisabilityingreenprofessionspactastudyprotocolofapragmaticrandomisedcontrolledtrial AT davidebert clinicalandcosteffectivenessofaguidedinternetbasedacceptanceandcommitmenttherapytoimprovechronicpainrelateddisabilityingreenprofessionspactastudyprotocolofapragmaticrandomisedcontrolledtrial |