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Protocol and methods for testing the efficacy of well-being therapy in chronic migraine patients: a randomized controlled trial.

ABSTRACT: BACKGROUND:Chronic migraine is a chronic medical condition associated with resistance to pharmacological treatment and poor benefits from the psychological interventions studied to date, including acceptance and commitment therapy or mindfulness. This manuscript describes the rationale and methods for a pilot feasibility study designed to (1) establish and (2) evaluate the feasibility and acceptability of research procedures and interventions to investigate whether well-being therapy improves outcomes relative to a control condition. METHODS:The current intervention will use a randomized controlled trial design, wherein 30 outpatients with chronic migraine will be randomized (1:1) to well-being therapy (n?=?15) or to a control condition (n?=?15). Primary outcomes include the level of disability caused by migraine and the frequency, duration, and intensity of migraine attacks; the secondary outcomes focus on anxiety, depression, psychological well-being, euthymia, and distress. Primary and secondary outcomes will be assessed at baseline, after sessions 4 and 8, and at 3-month follow-up. The Ethical Review Boards at the University-Hospital Careggi has approved the study (5th December 2017). DISCUSSION:Identifying medium-term interventions able to improve chronic migraine is relevant to manage this illness. The present randomized trial might represent a step forward for managing chronic migraine by means of psychological interventions. TRIAL REGISTRATION:ClinicalTrial.gov Identifier: NCT03404336 . Registered on 19 January 2018.

SUBMITTER: Mansueto G

PROVIDER: S-EPMC6192307 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature

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Protocol and methods for testing the efficacy of well-being therapy in chronic migraine patients: a randomized controlled trial.

Mansueto Giovanni G De Cesaris Francesco F Geppetti Pierangelo P Cosci Fiammetta F

Trials 20181016 1

<h4>Background</h4>Chronic migraine is a chronic medical condition associated with resistance to pharmacological treatment and poor benefits from the psychological interventions studied to date, including acceptance and commitment therapy or mindfulness. This manuscript describes the rationale and methods for a pilot feasibility study designed to (1) establish and (2) evaluate the feasibility and acceptability of research procedures and interventions to investigate whether well-being therapy imp ...[more]

PMID: 30326932

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Project description:Introduction:Chronic migraine is a largely refractory condition affecting between 1 and 2.2% of the overall population worldwide, with females more affected than males. There are also high health and socioeconomic costs associated both for the individual and society. The mainstay of chronic migraine management is pharmacological, but the options available have limited efficacy and there are often unwanted side effects. There is some evidence for manual therapy as a treatment option for migraine, but its effectiveness for chronic migraine is unknown. Therefore, we have designed a pragmatic randomised control trial to investigate whether adding manual therapy to the tertiary specialist treatment of chronic migraine improves patient-reported outcomes. Methods:A pragmatic, randomised controlled trial in a hospital tertiary headache clinic. Participants will be randomised into one of two groups: treatment as usual or treatment as usual plus manual therapy. The primary outcome measure will be a change in the Headache Impact Test score. Secondary outcomes will also be measured over the 12-week study period including changes in headache frequency, migraine specific quality of life and reductions in relevant medicine consumption. The manual therapy group will have five treatment sessions each lasting 30?min. The recruitment target of 64 participants will allow power at 80% with p?=?0.05 using minimal clinical difference for Headache Impact Test of 3.7 and includes provision for a 10% dropout rate. Recruitment will take place between August 2018 and February 2019. The results will form part of a doctoral study and be published in peer-reviewed journals and presented at national/international conferences. Discussion:Current pharmacological approaches have limited effects in the management of chronic migraine and there is a requirement to improve treatment options and reduce the health and economic burden of the condition. Manual therapy has been shown to be effective in other chronic pain conditions as well as other primary headaches. This study will explore the effectiveness of manual therapy as an adjunctive approach to the management of chronic migraine. Trial registration:The trial has received a favourable opinion from the UK Health Research Authority (IRAS 228901) and is registered at ClinicalTrials.gov.number NCT03395457. Registered 1st March 2018.

Project description:Stroke is a major public health threat globally. Psychosocial well-being may be affected following stroke. Depressive symptoms, anxiety, general psychological distress and social isolation are prevalent. Approximately one third report depressive symptoms and 20% report anxiety during the first months or years after the stroke. Psychosocial difficulties may impact significantly on long-term functioning and quality of life, reduce the effects of rehabilitation services and lead to higher mortality rates. The aim of the study is to evaluate the effect of a previously developed and feasibility tested dialogue-based psychosocial intervention aimed at promoting psychosocial well-being and coping following stroke among stroke survivors with and without aphasia.The study will be conducted as a multicenter, randomized, single blind controlled trial with one intervention and one control arm. It will include a total of 330 stroke survivors randomly allocated into either an intervention group (dialogue-based intervention to promote psychosocial well-being) or a control group (usual care). Participants in the intervention group will receive eight individual sessions of supported dialogues in their homes during the first six months following an acute stroke. The primary outcome measure will be psychosocial well-being measured by the General Health Questionnaire (GHQ). Secondary outcome measures will be quality of life (SAQoL), sense of coherence (SOC), and depression (Yale). Process evaluation will be conducted in a longitudinal mixed methods study by individual qualitative interviews with 15-20 participants in the intervention and control groups, focus group interviews with the intervention personnel and data collectors, and a comprehensive analysis of implementation fidelity.The intervention described in this study protocol is based on thorough development and feasibility work, guided by the UK medical research council framework for developing and testing complex interventions. It combines classical effectiveness evaluation with a thorough process evaluation. The results from this study may inform the development of further trials aimed at promoting psychosocial well-being following stroke as well as inform the psychosocial follow up of stroke patients living at home.NCT02338869 ; registered 10/04/2014 (On-going trial).

Project description:BackgroundLow back pain causes more global disability than any other condition. Once the acute pain becomes chronic, about two-thirds of sufferers will not fully recover after 1-2 years. There is a paucity of effective treatments for non-specific, chronic low back pain. It has been noted that low back pain is associated with changes in the connective tissue in the affected area, and a very low-impact treatment, Esoteric Connective Tissue Therapy (ECTT), has been developed to restore flexibility in connective tissue. ECTT uses patterns of very small, circular movements, to the legs, arms, spine, sacrum and head, which anecdotally are effective in pain relief. In an unpublished single-arm phase I/II trial with chronic pain patients, ECTT showed a 56% reduction in pain after five treatments and 45% and 54% improvements at 6 months and 7-9 years of follow-up respectively.MethodsThe aim of this randomised controlled trial is to compare ECTT with physiotherapy for reducing pain and improving physical function and physical and mental well-being in patients with chronic low back pain. The trial will be held at two hospitals in Vietnam. One hundred participants with chronic low back pain greater than or equal to 40/100 on the visual analogue scale will be recruited and randomised to either ECTT or physiotherapy. Four weekly treatments will be provided by two experienced ECTT practitioners (Treatment Group, 40 minutes each) and hospital-employed physiotherapy nurses (Control Group, 50 minutes). The primary outcomes will be changes in pain, physical function per the Quebec Pain Functionality Questionnaire and physical and mental well-being recorded by the Short Form Health Survey (SF-36), with mixed modelling used as the primary statistical tool because the data are longitudinal. Initial follow-up will be at either 4 or 8 months, with a second follow-up after 12 months.DiscussionThe trial design has important strengths, because it is to be conducted in hospitals under medical supervision, because ECTT is to be compared with a standard therapy and because the assessor and analyst are to be blinded. The findings from this trial will provide evidence of the efficacy of ECTT for chronic low back pain compared with standard physiotherapy treatment.Trial registrationAustralian New Zealand Clinical Trials Registry, ACTRN12616001196437 . Registered on 30 August 2016.

Project description:BACKGROUND:Migraine affects approximately 20% of the population. Conventional care for migraine is suboptimal; overuse of medications for the treatment of episodic migraines is a risk factor for developing chronic daily headache. The study of non-pharmaceutical approaches for prevention of migraine headaches is therefore warranted. Craniosacral therapy (CST) is a popular non-pharmacological approach to the treatment or prevention of migraine headaches for which there is limited evidence of safety and efficacy. In this paper, we describe an ongoing feasibility study to assess the safety and efficacy of CST in the treatment of migraine, using a rigorous and innovative randomized controlled study design involving low-strength static magnets (LSSM) as an attention control intervention. METHODS:The trial is designed to test the hypothesis that, compared to those receiving usual care plus a treatment with low-strength static magnets (attention-control complementary therapy), subjects receiving usual medical care plus CST will demonstrate significant improvement in: quality-of-life as measured by the Headache Impact Test (HIT-6); reduced frequency of migraine; and a perception of clinical benefit. Criteria for inclusion are either gender, age > 11, English or Spanish speaking, meeting the International Classification of Headache Disorders (ICHD) criteria for migraine with or without aura, a headache frequency of 5 to 15 per month over at least two years. After an 8 week baseline phase, eligible subjects are randomized to either CST or an attention control intervention, low strength static magnets (LSSM). To evaluate possible therapist bias, videotaped encounters are analyzed to assess for any systematic group differences in interactions with subjects. RESULTS:169 individuals have been screened for eligibility, of which 109 were eligible for the study. Five did not qualify during the baseline phase because of inadequate headache frequency. Nineteen have withdrawn from the study after giving consent. CONCLUSION:This report endorses the feasibility of undertaking a rigorous randomized clinical trial of CST for migraine using a standardized CST protocol and an innovative control protocol developed for the study. Subjects are able and willing to complete detailed headache diaries during an 8-week baseline period, with few dropouts during the study period, indicating the acceptability of both interventions. TRIAL REGISTRATION:ClinicalTrials.gov NCT00665236.

Project description:BackgroundMedical student burnout is a prevalent problem with adverse long-term outcomes. Incorporating psychological resource-building interventions into comprehensive burnout prevention approaches during medical training is an identified priority among educators. These interventions could reduce burnout risk by buffering students against nonmodifiable career stressors. However, there is a need for rigorous investigation into optimal intervention targets and methods. Psychological flexibility (PF) is an adaptive behavioral skill set that has demonstrated relationships with medical student burnout and well-being. More broadly, there is evidence that PF mediates burnout and well-being outcomes and may be a protective factor. Efficacy studies assessing the benefits of interventions targeting PF among medical students are needed. Research also supports the need to establish optimal methods for increasing intervention efficacy in the context of individual differences in burnout and PF by using individualized approaches.ObjectiveThis study aims to assess whether an app-delivered PF intervention (Acceptance and Commitment Training) reduces burnout and improves well-being among medical students. We will examine whether changes in burnout and well-being are mediated by changes in PF. The potential benefits of an individualized version of the app versus those of a nonindividualized version will also be evaluated.MethodsIn this 3-arm, parallel, randomized controlled study, a sample of medical students will be randomly allocated to 1 of 3 intervention arms (individualized, nonindividualized, and waiting list) by using a 1:1:1 allocation ratio. Participants in the individualized and nonindividualized intervention arms will have 5 weeks to access the app, which includes a PF concepts training session (stage 1) and access to short PF skill activities on demand (stage 2). Stage 2 will be either individualized to meet participants' identified PF training needs at each log-in or nonindividualized.ResultsBurnout, well-being, and PF will be assessed at baseline and after the intervention. Quantitative analyses will include descriptive and inferential statistics. We hypothesize that the Acceptance and Commitment Training intervention app will be effective in improving burnout and well-being and that changes in these outcomes will be mediated by changes in PF. We further hypothesize that participants in the individualized intervention group will demonstrate greater improvements in burnout and well-being outcomes than those in the nonindividualized group.ConclusionsThe findings of this study could guide the development of burnout prevention and well-being initiatives for medical students. Identifying PF as a mediating process would provide support for the delivery of preventive intervention programs that train individuals to strengthen this psychological resource before burnout symptoms emerge. This would be an important step in addressing and potentially offsetting the significant costs of burnout among medical students and physicians. Demonstrating the superiority of an individualized version of the app over a nonindividualized version would have implications for enhancing intervention precision and efficacy by using scalable interventions.Trial registrationAustralian New Zealand Clinical Trials Registry ANZCTR 12621000911897; https://www.anzctr.org.au/ACTRN12621000911897.aspx.International registered report identifier (irrid)PRR1-10.2196/32992.

Project description:IntroductionOver the last two decades, the use of opioids for the treatment of chronic pain in England has steadily increased despite lack of evidence of both long-term effectiveness in pain relief and significant, well-documented physical and mental adverse events. Guidelines recommend tapering when harms outweigh benefits, but the addictive nature of opioids hinders simple dose-reduction strategies. Improving the Well-being of people with Opioid Treated CHronic pain (I-WOTCH) trial tests a multicomponent self-management intervention aimed to help patients with chronic non-malignant pain taper opioid doses. This paper outlines the methods to be used for the economic analysis of the I-WOTCH intervention compared with the best usual care.Methods and analysisEconomic evaluation alongside the I-WOTCH study, prospectively designed to identify, measure and value key healthcare resource use and outcomes arising from the treatment strategies being compared. A within-trial cost-consequences analysis and a model-based long-term cost-effectiveness analysis will be conducted from the National Health Service and Personal Social Service perspective in England. The former will quantify key parameters to populate a Markov model designed to estimate the long-term cost and quality-adjusted life years of the I-WOTCH intervention against best usual care. Regression equations will be used to estimate parameters such as transition probabilities, utilities, and costs associated with the model's states and events. Probabilistic sensitivity analysis will be used to assess the impact of parameter uncertainty onto the predicted costs and health outcomes, and the resulting value for money assessment of the I-WOTCH intervention.Ethics and disseminationFull ethics approval was granted by Yorkshire & The Humber-South Yorkshire Research Ethics Committee on 13 September 2016 (16/YH/0325). Current protocol: V.1.7, date 31 July 2019. Findings will be disseminated in peer-reviewed journals, scientific conferences, newsletters and websites.Trial registration numberInternational Standard Randomised Controlled Trial Number (49 470 934); Pre-result.

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Protocol and methods for testing the efficacy of well-being therapy in chronic migraine patients: a randomized controlled trial.

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Protocol and methods for testing the efficacy of well-being therapy in chronic migraine patients: a randomized controlled trial.

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