scholarly journals Acceptance and Commitment Therapy for Muscle Disease (ACTMus): protocol for a two-arm randomised controlled trial of a brief guided self-help ACT programme for improving quality of life in people with muscle diseases

BMJ Open ◽  
2018 ◽  
Vol 8 (10) ◽  
pp. e022083 ◽  
Author(s):  
Michael R Rose ◽  
Sam Norton ◽  
Chiara Vari ◽  
Victoria Edwards ◽  
Lance McCracken ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomised Controlled Trial ◽  
Acceptance And Commitment Therapy ◽  
Controlled Trial ◽  
Muscle Disease ◽  
Self Help ◽  
Commitment Therapy ◽  
Acceptance And Commitment ◽  
Randomised Controlled

IntroductionIn adults, muscle disease (MD) is often a chronic long-term condition with no definitive cure. It causes wasting and weakness of the muscles resulting in a progressive decline in mobility, alongside other symptoms, and is typically associated with reduced quality of life (QoL). Previous research suggests that a psychological intervention, and in particular Acceptance and Commitment Therapy (ACT), may help improve QoL in MD. ACT is a newer type of cognitive behavioural treatment that aims to improve QoL by virtue of improvement in a process called psychological flexibility. The primary aim of this randomised controlled trial (RCT) is to evaluate the efficacy of a guided self-help ACT programme for improving QoL in people with MD. Main secondary outcomes are mood, symptom impact, work and social adjustment and function at 9-week follow-up.Methods and analysisAcceptance and Commitment Therapy for Muscle Disease is an assessor-blind, multicentre, two-armed, parallel-group RCT to assess the efficacy of ACT plus standard medical care (SMC) compared with SMC alone. Individuals with a diagnosis of one of four specific MDs, with a duration of at least 6 months and with mild to moderate anxiety or depression (Hospital Anxiety and Depression Scale score ≥8) will be recruited from UK-based MD clinics and MD patient support organisations. Participants will be randomised to either ACT plus SMC or SMC alone by an independent randomisation service. Participants will be followed up at 3, 6 and 9 weeks. Analysis will be intention to treat, conducted by the trial statistician who will be blinded to treatment allocation.Ethics and disseminationThe study has received full ethical approval. Study results will be disseminated via peer-reviewed publications, conference presentations and journal articles. Data obtained from the trial will enable clinicians and health service providers to make informed decisions regarding the efficacy of ACT for improving QoL for patients with MD.Trial registration numberNCT02810028.Protocol versionV.11 (4 April 2017).

An acceptance and commitment therapy self-help intervention for carers of patients in palliative care: Protocol of a feasibility randomised controlled trial

2016 ◽  
Vol 24 (5) ◽  
pp. 685-704 ◽  
Author(s):  
Esther L Davis ◽  
Frank P Deane ◽  
Geoffrey CB Lyons
Keyword(s):  
Palliative Care ◽  
Randomised Controlled Trial ◽  
Acceptance And Commitment Therapy ◽  
Controlled Trial ◽  
Well Being ◽  
Self Help ◽  
Feasibility Randomised Controlled Trial ◽  
Commitment Therapy ◽  
Acceptance And Commitment ◽  
Randomised Controlled

Undertaking a caregiving role at end of life can have enduring psychological consequences for carers, including poor adjustment in bereavement. Acceptance and commitment therapy–based interventions have demonstrated effectiveness in helping people cope with a range of life challenges. This article presents the protocol of a feasibility randomised controlled trial of an acceptance and commitment therapy self-help intervention for psychological distress and grief in carers of patients in palliative care. We will assess feasibility and acceptability of the trial procedures and intervention as well as preliminary effectiveness of the intervention on carer well-being outcomes.

scholarly journals 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 ◽  
2020 ◽  
Vol 10 (9) ◽  
pp. e034271 ◽  
Author(s):  
Yannik Terhorst ◽  
Lina Braun ◽  
Ingrid Titzler ◽  
Claudia Buntrock ◽  
Johanna Freund ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Chronic Pain ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Acceptance And Commitment Therapy ◽  
Controlled Trial ◽  
Acceptance And Commitment ◽  
Randomised Controlled ◽  
Pragmatic Randomised Controlled Trial

IntroductionChronic 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 analysisA 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 disseminationThis 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 numberGerman Clinical Trial Registration: DRKS00014619. Registered on 16 April 2018.

scholarly journals Early Parenting Acceptance and Commitment Therapy ‘Early PACT’ for parents of infants with cerebral palsy: a study protocol of a randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e037033
Author(s):  
Koa Whittingham ◽  
Jeanie Sheffield ◽  
Catherine Mak ◽  
Corrine Dickinson ◽  
Roslyn N Boyd
Keyword(s):  
High Risk ◽  
Randomised Controlled Trial ◽  
Acceptance And Commitment Therapy ◽  
Controlled Trial ◽  
Trial Registration ◽  
Support Programme ◽  
Commitment Therapy ◽  
Acceptance And Commitment ◽  
Randomised Controlled

IntroductionNew international clinical practice guidelines exist for identifying infants at high risk of cerebral palsy (CP) earlier: between 12 to 24 weeks corrected age, significantly earlier than previous diagnosis windows in Australia at 19 months. The earlier detection of infants at high risk of CP creates an opportunity for earlier intervention. The quality of the parent-infant relationship impacts various child outcomes, and is leveraged in other forms of intervention. This paper presents the protocol of a randomised controlled trial of an online parent support programme, Early Parenting Acceptance and Commitment Therapy (Early PACT) for families of infants identified as at high risk of CP. We predict that participating in the Early PACT programme will be associated with improvements in the parent-infant relationship, in parent mental health and well-being as well as infant behaviour and quality of life.Methods and analysisThis study aims to recruit 60 parents of infants (0 to 2 years old corrected age) diagnosed with CP or identified as at high risk of having CP. Participants will be randomly allocated to one of two groups: Early PACT or waitlist control (1:1). Early PACT is an online parent support programme grounded in Acceptance and Commitment Therapy (ACT). It is delivered as a course on an open source course management system called edX. Early PACT is designed to support parental adjustment and parent-infant relationship around the time of early diagnosis. Assessments will be conducted at baseline, following completion of Early PACT and at 6-month follow-up (retention). The primary outcome will be the quality of parent-child interactions as measured by the Emotional Availability Scale. Standard analysis methods for randomised controlled trial will be used to make comparisons between the two groups (Early PACT and waitlist control). Retention of effects will be examined at 6-month follow-up.Ethics and disseminationThis study is approved through appropriate Australian and New Zealand ethics committees (see in text) with parents providing written informed consent. Findings from this trial will be disseminated through peer-reviewed journal publications and conference presentations.Trial registration detailsThis trial has been prospectively registered on 12 June 2018 to present (ongoing) with the Australian New Zealand Clinical Trials Registry (ACTRN12618000986279); https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=3 74 896

scholarly journals Efficacy of Acceptance and Commitment Therapy in Daily Life (ACT-DL) in early psychosis: study protocol for a multi-centre randomized controlled trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Ulrich Reininghaus ◽  
Annelie Klippel ◽  
Henrietta Steinhart ◽  
Thomas Vaessen ◽  
Martine van Nierop ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomised Controlled Trial ◽  
Acceptance And Commitment Therapy ◽  
Daily Life ◽  
Controlled Trial ◽  
Psychotic Experiences ◽  
Intervention Period ◽  
Commitment Therapy ◽  
Acceptance And Commitment ◽  
Randomised Controlled

Abstract Background Psychotic experiences, social functioning and general psychopathology are important targets for early intervention in individuals with Ultra-High-Risk state (UHR) and a first-episode psychosis (FEP). Acceptance and Commitment Therapy (ACT) is a promising, next-generation Cognitive Behavioural Therapy (CBT) that aims to modify these targets, but evidence on sustainable change and its underlying mechanisms in individuals’ daily lives remains limited. The aim of the INTERACT study is to investigate the efficacy of a novel ecological momentary intervention, Acceptance and Commitment Therapy in Daily Life (ACT-DL) in a multi-centre randomised controlled trial of individuals with UHR or FEP. Methods/design In a multi-centre randomised controlled trial, individuals aged 16–65 years with UHR or FEP will be randomly allocated to ACT-DL in addition to treatment as usual (TAU) as the experimental condition or a control condition of TAU only, which will include – for the entire study period – access to routine mental health care and, where applicable, CBT for psychosis (CBTp). Outcomes will be assessed at baseline (i.e. before randomisation), post-intervention (i.e. after the 8-week intervention period), and 6-month and 12-month follow-ups (i.e. 6 and 12 months after completing the intervention period) by blinded assessors. The primary outcome will be distress associated with psychotic experiences, while secondary outcomes will include (momentary) psychotic experiences, social functioning and psychopathology. Process measures to assess putative mechanisms of change will include psychological flexibility, stress sensitivity and reward experiences. In addition, acceptability, treatment adherence and treatment fidelity of ACT-DL will be assessed. Discussion The current study is the first to test the efficacy of ACT-DL in individuals with UHR and FEP. If this trial demonstrates the efficacy of ACT-DL, it has the potential to significantly advance the treatment of people with UHR and FEP and, more generally, provides initial support for implementing mHealth interventions in mental health services. Trial registration Netherlands Trial Register, ID: NTR4252. Registered on 26 September 2013.

scholarly journals A pilot case series of a brief acceptance and commitment therapy (ACT)-based guided self-help intervention for improving quality of life and mood in muscle disorders

2017 ◽  
Vol 10 ◽  
Author(s):  
Christopher D. Graham ◽  
Trudie Chalder ◽  
Michael R. Rose ◽  
Dimitri Gavriloff ◽  
Lance M. McCracken ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Acceptance And Commitment Therapy ◽  
Case Series ◽  
Psychological Flexibility ◽  
Secondary Outcome ◽  
Muscle Disorders ◽  
Self Help ◽  
Commitment Therapy ◽  
Acceptance And Commitment

AbstractThis study aimed to demonstrate proof of concept and acceptability of a brief acceptance and commitment therapy (ACT)-based guided self-help intervention for improving quality of life (QoL) and mood for people with muscle disorders (MD). A case-series with an AB design was used to assess changes in primary (QoL) and secondary (depression and anxiety) outcome variables across the period of study. Change in the psychological process targeted by ACT – psychological flexibility – was also investigated, to allow insight into possible treatment mechanisms. Post-intervention, participants also completed a brief free-text evaluation. Relative to pre-intervention scores, four (of seven) participants showed varying degrees of improvement in all primary and secondary outcome variables and were thus considered responders. However, consistent concomitant improvements in psychological flexibility were not apparent. Participants reported a mostly positive experience of the intervention; all appeared to complete the intervention, and no adverse events were reported. Nonetheless, there was evidence that those with compromised concentration or who report good initial QoL and low levels of distress may derive less benefit. Although several methodological weaknesses limit the strength of our conclusions, this ACT-based guided self-help intervention shows encouraging utility for improving QoL and mood in MD.

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