Acceptance and commitment therapy for episodic migraine: Rationale and design of a pilot randomized controlled trial.

Migraine is a debilitating disorder with limited pharmacological options. Many migraine medications can have intolerable side effects leading patients to seek complementary and integrative health (CIM) approaches for treatment. One option that is growing in popularity and evidence is Acceptance and Commitment Therapy (ACT), a mindfulness-based therapy. The purpose of this paper is to describe how ACT may be an effective modality integrated into the treatment of migraine and to describe the design of a pilot study of ACT for migraine. First, we review the research and the promise of mindfulness therapies for the treatment of migraine. Then, we describe how ACT differs from other mindfulness therapies for migraine and why it can be a promising option for these patients. Finally, we summarize the design of a pilot study designed to determine the feasibility of performing a future fully powered study to determine the effectiveness of ACT on migraine frequency and disability. This pilot study includes unique features, including a remotely-delivered ACT intervention and the measurement of cortisol levels before and after the intervention.

Perceptions of Chiropractic Care Among Women With Migraine: A Qualitative Substudy Using a Grounded-Theory Framework.

OBJECTIVE: The purpose of this study was to characterize expectations, attitudes, and experiences of individuals with migraine who were randomly assigned to receive chiropractic care delivered within a randomized controlled trial in a hospital-based integrative care center. METHODS: This qualitative substudy was conducted as a part of a 2-arm pilot pragmatic randomized controlled trial investigating a multimodal model of chiropractic care for women with episodic migraine (4-13 migraines per month). Women were randomly assigned to chiropractic care (10 sessions over 14 weeks) plus enhanced usual care vs enhanced usual care alone. Semistructured interviews were conducted at baseline and 14-week follow-up with 15 randomly selected participants from the 29 participants randomized to the chiropractic group. Qualitative analysis was performed by 2 independent reviewers using a constant comparative method of analysis for generating grounded theory. RESULTS: Integrating baseline and follow-up interviews, 3 themes emerged: over the course of treatment with chiropractic care, participants became more aware of the role of musculoskeletal tension, pain, and posture in triggering migraine; participants revised their prior conceptions of chiropractic care beyond spinal manipulation; and participants viewed the chiropractor-patient relationship as an essential and valuable component to effectively managing their migraines. CONCLUSION: In this qualitative study, women with episodic migraine after receiving comprehensive chiropractic care described chiropractic as a multimodal intervention where they learned about musculoskeletal contributions to migraine, discovered new ways to affect their symptoms, and developed a collaborative patient-practitioner relationship. The results of this study provide insights into perceptions of chiropractic care among women with migraine and suggestions for future trials.

Multimodal chiropractic care for migraine: A pilot randomized controlled trial.

BACKGROUND: Spinal manipulation may reduce migraine frequency, but effects of multimodal chiropractic care on migraine frequency have not been evaluated. METHODS: We conducted a pilot randomized controlled trial comparing multimodal chiropractic care + enhanced usual care (MCC+) versus enhanced usual care alone (EUC) among adult women with episodic migraine. EUC was comprised of usual medical care and migraine education literature. MCC+ participants received 10 sessions of chiropractic care over 14 weeks. Primary aims evaluated feasibility of recruitment, retention, protocol adherence, and safety. Change in migraine days was a secondary aim. RESULTS: Of 422 patients screened, 61 were randomized over 20 months. Fifty-seven (93%) completed daily migraine logs during the intervention, 51 (84%) completed final follow-up, and 45 (74%) completed all assessments. Twenty-four of 29 MCC+ participants (83%) attended > 75% of the chiropractic sessions. Ninety-eight non-serious adverse events were reported by 26 participants (43%) with 39 events among 11 EUC participants and 59 events among 15 MCC+ participants. MCC+ participants experienced greater reductions in migraine days (-2.9 days for MCC+ vs. -1.0 days for EUC, difference = -1.9; 95% confidence interval: -3.5, -0.4). CONCLUSIONS: Pre-specified feasibility criteria were not met, but deficits were remediable. Preliminary data support a definitive trial of MCC+ for migraine. TRIAL REGISTRATION: This study is registered at Clinicaltrials.gov (NCT03177616).

The Association Between Pain Trajectories With Posttraumatic Stress Disorder, Depression, and Disability During the Acute Posttrauma Period.

OBJECTIVE: Exposure to a traumatic event is common among US adults, yet only a small fraction develops posttraumatic stress disorder (PTSD). Higher pain after a traumatic injury has been associated with higher PTSD symptoms and thus may be a risk factor. However, few studies have examined how pain during the period immediately after a trauma, referred to as the acute posttrauma period, relates later to PTSD outcomes. METHODS: A sample of (n = 87) individuals who had experienced a traumatic injury assessed their pain through daily mobile assessments for the first month after injury. PTSD, depression, and functional impairment were assessed at the time of trauma and 1 and 3 months later. RESULTS: Using latent class growth analysis, three trajectories of pain were identified: low pain (41.3%), decreasing pain (43.7%), and high pain (14.9%). At baseline, the high-pain class reported higher levels of depression and functional impairment than did the low-pain group. From baseline to 3 months, the low-pain class experienced a reduction in PTSD, depression, and functional impairment, whereas the high-pain class experienced an increase in PTSD symptoms, persistent depression, and functional impairment. CONCLUSIONS: These results demonstrate that there are distinct trajectories of pain after a traumatic injury. Persistent elevated pain is associated with more severe psychopathology in the period immediately after a traumatic injury.

Different trajectories of PTSD symptoms during the acute post-trauma period.

The majority of adults in the United States will experience a potentially traumatic event during their lifetime, yet only a subset will develop posttraumatic stress disorder (PTSD). The trajectory of symptoms in the period of time immediately following the trauma (the acute post-trauma period) may be important in determining which individuals develop PTSD. The current study examined trajectories of PTSD symptom severity across the acute post-trauma period and if membership in these trajectories was predictive of PTSD symptom severity, depression symptoms, and functional impairment 1- and 3-months post-trauma. Four trajectories were identified: low and decreasing, rapid decreasing, slow decreasing, and consistently high. Further, trajectory membership in the acute post-trauma period was found to predict differences in PTSD symptoms, depression symptoms, and functional impairment severity at both 1- and 3- months post-trauma. These findings highlight a relationship between PTSD symptoms during the acute post-trauma period and later impairment.

Carer administration of as-needed subcutaneous medication for breakthrough symptoms in people dying at home: the CARiAD feasibility RCT.

BACKGROUND: Most people who are dying want to be cared for at home, but only half of them achieve this. The likelihood of a home death often depends on the availability of able and willing lay carers. When people who are dying are unable to take oral medication, injectable medication is used. When top-up medication is required, a health-care professional travels to the dying person's home, which may delay symptom relief. The administration of subcutaneous medication by lay carers, although not widespread UK practice, has proven to be key in achieving better symptom control for those dying at home in other countries. OBJECTIVES: To determine if carer administration of as-needed subcutaneous medication for common breakthrough symptoms in people dying at home is feasible and acceptable in the UK, and if it would be feasible to test this intervention in a future definitive randomised controlled trial. DESIGN: We conducted a two-arm, parallel-group, individually randomised, open pilot trial of the intervention versus usual care, with a 1 : 1 allocation ratio, using convergent mixed methods. SETTING: Home-based care without 24/7 paid care provision, in three UK sites. PARTICIPANTS: Participants were dyads of adult patients and carers: patients in the last weeks of their life who wished to die at home and lay carers who were willing to be trained to give subcutaneous medication. Strict risk assessment criteria needed to be met before approach, including known history of substance abuse or carer ability to be trained to competency. INTERVENTION: Intervention-group carers received training by local nurses using a manualised training package. MAIN OUTCOME MEASURES: Quantitative data were collected at baseline and 6-8 weeks post bereavement and via carer diaries. Interviews with carers and health-care professionals explored attitudes to, experiences of and preferences for giving subcutaneous medication and experience of trial processes. The main outcomes of interest were feasibility, acceptability, recruitment rates, attrition and selection of the most appropriate outcome measures. RESULTS: In total, 40 out of 101 eligible dyads were recruited (39.6%), which met the feasibility criterion of recruiting > 30% of eligible dyads. The expected recruitment target (≈50 dyads) was not reached, as fewer than expected participants were identified. Although the overall retention rate was 55% (22/40), this was substantially unbalanced [30% (6/20) usual care and 80% (16/20) intervention]. The feasibility criterion of > 40% retention was, therefore, considered not met. A total of 12 carers (intervention, n = 10; usual care, n = 2) and 20 health-care professionals were interviewed. The intervention was considered acceptable, feasible and safe in the small study population. The context of the feasibility study was not ideal, as district nurses were seriously overstretched and unfamiliar with research methods. A disparity in readiness to consider the intervention was demonstrated between carers and health-care professionals. Findings showed that there were methodological and ethics issues pertaining to researching last days of life care. CONCLUSION: The success of a future definitive trial is uncertain because of equivocal results in the progression criteria, particularly poor recruitment overall and a low retention rate in the usual-care group. Future work regarding the intervention should include understanding the context of UK areas where this has been adopted, ascertaining wider public views and exploring health-care professional views on burden and risk in the NHS context. There should be consideration of the need for national policy and of the most appropriate quantitative outcome measures to use. This will help to ascertain if there are unanswered questions to be studied in a trial. TRIAL REGISTRATION: Current Controlled Trials ISRCTN11211024. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 25. See the NIHR Journals Library website for further project information.

Most people in the UK would prefer to die at home, but only half of them achieve this. This usually depends on having able and willing lay carers (family or friends) to help look after them. Once swallowing is not possible, medicine is given continually under the skin (syringe driver). If common problems such as pain, vomiting or agitation break through, health-care professionals attend to give extra doses. The wait for a health-care professional to arrive can be distressing. In the UK, it is legal (but not routine) for lay carers to give needle-free subcutaneous injections themselves. We reworked an Australian carer education package for UK use. The best way to find out if this would work well is to do a randomised controlled trial. This is a test in which, at random, half of the people taking part receive 'usual care' and the other half receive the 'new care' or intervention. A pilot randomised controlled trial (a 'test' trial to see if a larger one is worth doing) was carried out to determine if lay carer injections were possible in the UK. We approached 90 dyads (a dying person and a key carer) and, of these, 40 were willing to take part and 22 completed the follow-up visit, so we could analyse their data. Of these 22 dyads, 16 were in the intervention group (lay carer injects) and six were in the control group (usual care). All carers were asked to keep a diary. Carers and health-care professionals were interviewed (qualitative study) and carer preferences were assessed. This new practice was safe, acceptable and welcomed. Carer confidence increased rapidly, symptom control was quicker and the interviews backed up these findings. Recruitment was low owing to overstretched health-care professionals. Only certain families were picked. Dyads in the usual-care group often wished they were in the intervention group. Carers found it difficult to complete some of the questionnaires that were used to measure the effect of the intervention. Therefore, uncertainty remains as to whether or not a full trial should proceed. Because the practice is already legal, some areas in the UK are already undertaking it. We plan to study what makes this practice possible or less possible to achieve.

Patient Disclosure of Complementary and Integrative Health Approaches in an Academic Health Center.

BACKGROUND: Effective patient-doctor communication about complementary and integrative health (CIH) is crucial to coordinate multimodal treatment for complex conditions. While rates of patient disclosure of CIH use to physicians have increased in the United States over the last 30 years, many patients still do not disclose these facts. Integrating CIH approaches within academic medical centers may enhance the communication, but this has not been explicitly studied. OBJECTIVE: To examine rates of patient disclosure of CIH to physicians and reasons for nondisclosure. METHODS: We surveyed 1177 patients at an academic center's CIH clinic regarding their CIH use and disclosure of CIH use to their physician. RESULTS: Of the 1067 who responded to the disclosure questions, 80.1% had discussed their CIH use with their physician, while 19.9% did not. Of those who did not disclose, lack of physician inquiry was reported by 58% as the principal reason. DISCUSSION: Within an academic center, there is still a need to improve communication about CIH use. Possible strategies might include continued education of both patients and physicians about CIH and communication skills and integration of CIH disclosure into routine patient health questionnaires.

Development and Implementation of the Integrative Toolbox for Headache Management.

Patients with migraine are interested in integrative therapies and overall wellness. They also suffer from social isolation as they try to manage a chronic medical condition. We implemented a three-part workshop structured as a group visit that teaches multiple integrative therapies from specialists and offers a chance for shared support and learning.

CARer-ADministration of as-needed subcutaneous medication for breakthrough symptoms in homebased dying patients (CARiAD): study protocol for a UK-based open randomised pilot trial.

BACKGROUND: While the majority of seriously ill people wish to die at home, only half achieve this. The likelihood of someone dying at home often depends on the availability of able and willing lay carers to support them. Dying people are usually unable to take oral medication. When top-up symptom relief medication is required, a clinician travels to the home to administer injectable medication, with attendant delays. The administration of subcutaneous injections by lay carers, though not widespread practice in the UK, has proven key in achieving home deaths in other countries. Our aim is to determine if carer-administration of as-needed subcutaneous medication for four frequent breakthrough symptoms (pain, nausea, restlessness and noisy breathing) in home-based dying patients is feasible and acceptable in the UK. METHODS: This paper describes a randomised pilot trial across three UK sites, with an embedded qualitative study. Dyads of adult patients/carers are eligible, where patients are in the last weeks of life and wish to die at home, and lay carers who are willing to be trained to give subcutaneous medication. Dyads who do not meet strict risk assessment criteria (including known history of substance abuse or carer ability to be trained to competency) will not be approached. Carers in the intervention arm will receive a manualised training package delivered by their local nursing team. Dyads in the control arm will receive usual care. The main outcomes of interest are feasibility, acceptability, recruitment rates, attrition and selection of the most appropriate outcome measures. Interviews with carers and healthcare professionals will explore attitudes to, experiences of and preferences for giving subcutaneous medication and experience of trial processes. The study has obtained full ethical approval. DISCUSSION: This study will rehearse the procedures and logistics which will be undertaken in a future definitive randomised controlled trial and will inform the design of such a study. Findings will illuminate methodological and ethical issues pertaining to researching last days of life care. The study is funded by the National Institute for Health Research (Health Technology Assessment [HTA] project 15/10/37). TRIAL REGISTRATION: ISRCTN, ISRCTN 11211024 . Registered on 27 September 2016.

Implementing assessments via mobile during the acute posttrauma period: feasibility, acceptability and strategies to improve response rates.

Background: PTSD is posited to develop in the acute posttrauma period. Few studies have examined psychopathology symptoms within this period due to the demands on individuals in the first month after a trauma. Mobile devices can overcome these barriers. The feasibility of using mobile devices for this purpose, however, is unclear. Objective: The present study evaluated the acceptability of administering PTSD symptom assessments via a mobile application throughout the acute posttrauma period. Method: Participants (N = 90) were recruited from a Level 1 Trauma Center within M = 4.88 days of experiencing a traumatic event. A mobile application was placed on their smartphone that administered a daily self-report assessment of PTSD symptoms for 30 days. Participants were compensated US$1 for each assessment completed. Results: The overall response rate was 61.1% or M = 18.33, SD = 9.12 assessments. Assessments were accessed M = 65.2 minutes after participants were notified to complete them and took M = 2.52 minutes to complete. Participants reported that the daily assessments were not bothersome and were moderately helpful. Conclusion: The present study suggests that using mobile devices to monitor mental health symptoms during the acute posttrauma period is feasible and acceptable. Strategies are needed to determine how to best take advantage of these data once collected.

Antecedentes: Se ha propuesto que el Trastorno por Estrés Post-Traumático (TEPT) se desarrolla en el período post-trauma agudo. Pocos estudios han estudiado síntomas psicopatológicos durante este periodo, debido a las demandas de los individuos en el primer mes después de un trauma. Los dispositivos móviles pueden superar estas barreras. Sin embargo, la viabilidad de usar dispositivos móviles para este propósito no está clara. Objetivo: Este estudio evaluó la aceptabilidad de la administración de evaluaciones de síntomas de TEPT a través de una aplicación para dispositivos móviles durante el periodo agudo post-trauma. Método: Los participantes (N=90) fueron reclutados desde un Centro de Trauma de Nivel 1 con M=4,88 días de haber experimentado un evento traumático. Se instaló una aplicación en sus teléfonos móviles, que administró una evaluación diaria de autoreporte de síntomas de TEPT, por 30 días. Los participantes fueron compensados con US$1 por cada evaluación completada. Resultados: La tasa de respuesta general fue 61,1% o M=18,33, SD=9,12 evaluaciones. Se tuvo acceso a las evaluaciones M=65,2 minutos después que los participantes fueron notificados para completarlas y les tomó M=2,52 minutos completarlas. Los participantes reportaron que las evaluaciones diarias no fueron tediosas y fueron moderadamente útiles. Conclusión: El presente estudio sugiere que usar dispositivos móviles para monitorear síntomas de salud mental durante el periodo post-trauma agudo es viable y aceptable. Se necesitan estrategias para determinar cómo sacar el mayor provecho de estos datos una vez obtenidos.

The Moderating Effect of Childhood Maltreatment on the Relations Among PTSD Symptoms, Positive Urgency, and Negative Urgency.

Childhood maltreatment increases the risk for posttraumatic stress disorder (PTSD) and comorbid substance use disorder (SUD). One pathway by which this occurs is through impaired emotion regulation. Past research has shown that negative urgency, a deficit in the regulation of negative emotions, is strongly related to PTSD in those with comorbid SUD. However, there is minimal research on the relation between positive urgency and PTSD in those with comorbid SUD. The current study investigated the association between childhood maltreatment, positive urgency, negative urgency, and PTSD symptoms among those with SUD. Results suggested that PTSD was associated with negative urgency and positive urgency overall. Childhood maltreatment did not moderate the association between negative urgency and PTSD. Childhood emotional abuse, emotional neglect, and sexual abuse moderated the relation between positive urgency and PTSD (ΔR2 = .04 to .10). The association between PTSD and positive urgency was only significant at lower levels of emotional abuse and neglect. Future research should further examine the processing of positive emotions in those with PTSD and comorbid SUD. Findings might inform clinical interventions among populations exposed to childhood maltreatment to reduce or prevent the development of psychopathology.

Anti-predator meshing may provide greater protection for sea turtle nests than predator removal.

The problem of how to protect sea turtle nests from terrestrial predators is of worldwide concern. On Queensland's southern Sunshine Coast, depredation of turtle nests by the introduced European red fox (Vulpes vulpes) has been recorded as the primary terrestrial cause of egg and hatchling mortality. We investigated the impact of foxes on the nests of the loggerhead turtle (Caretta caretta) and occasional green turtle (Chelonia mydas) over ten nesting seasons. Meshing of nests with fox exclusion devices (FEDs) was undertaken in all years accompanied by lethal fox control in the first five-year period, but not in the second five-year period. Lethal fox control was undertaken in the study area from 2005 to February 2010, but foxes still breached 27% (range19-52%) of turtle nests. In the second five-year period, despite the absence of lethal fox control, the average percentage of nests breached was less than 3% (range 0-4%). Comparison of clutch depredation rates in the two five-year periods demonstrated that continuous nest meshing may be more effective than lethal fox control in mitigating the impact of foxes on turtle nests. In the absence of unlimited resources available for the eradication of exotic predators, the use of FEDs and the support and resourcing of a dedicated volunteer base can be considered an effective turtle conservation tool on some beaches.

Malignant transformation of endometriosis within the urinary bladder.

Although endometriosis of the pelvic organs is common, endometriosis of the urinary bladder is extremely rare. Malignant transformation of atypical endometriotic foci is an uncommon but well-documented sequela, occurring in approximately 1% of cases. This article reports the fourth case in the English literature of clear cell carcinoma arising from foci of endometriosis within the posterior bladder wall.

Current status of cannabis treatment of multiple sclerosis with an illustrative case presentation of a patient with MS, complex vocal tics, paroxysmal dystonia, and marijuana dependence treated with dronabinol.

Pain, spasticity, tremor, spasms, poor sleep quality, and bladder and bowel dysfunction, among other symptoms, contribute significantly to the disability and impaired quality of life of many patients with multiple sclerosis (MS). Motor symptoms referable to the basal ganglia, especially paroxysmal dystonia, occur rarely and contribute to the experience of distress. A substantial percentage of patients with MS report subjective benefit from what is often illicit abuse of extracts of the Cannabis sativa plant; the main cannabinoids include delta-9-tetrahydrocannabinol (delta9-THC) and cannabidiol. Clinical trials of cannabis plant extracts and synthetic delta9-THC provide support for therapeutic benefit on at least some patient self-report measures. An illustrative case is presented of a 52-year-old woman with MS, paroxysmal dystonia, complex vocal tics, and marijuana dependence. The patient was started on an empirical trial of dronabinol, an encapsulated form of synthetic delta9-THC that is usually prescribed as an adjunctive medication for patients undergoing cancer chemotherapy. The patient reported a dramatic reduction of craving and illicit use; she did not experience the "high" on the prescribed medication. She also reported an improvement in the quality of her sleep with diminished awakenings during the night, decreased vocalizations, and the tension associated with their emission, decreased anxiety and a decreased frequency of paroxysmal dystonia.

Phase III randomized multicenter study of a humanized anti-CD33 monoclonal antibody, lintuzumab, in combination with chemotherapy, versus chemotherapy alone in patients with refractory or first-relapsed acute myeloid leukemia.

PURPOSE: Lintuzumab (HuM195) is an unconjugated humanized murine monoclonal antibody directed against the cell surface myelomonocytic differentiation antigen CD33. In this study, the efficacy of lintuzumab in combination with induction chemotherapy was compared with chemotherapy alone in adults with first relapsed or primary refractory acute myeloid leukemia (AML). PATIENTS AND METHODS: Patients with relapsed or primary resistant AML (duration of first response, zero to 12 months) were randomly assigned to receive either mitoxantrone 8 mg/m(2), etoposide 80 mg/m(2), and cytarabine 1 g/m(2) daily for 6 days (MEC) in combination with lintuzumab 12 mg/m(2), or MEC alone. Overall response, defined as the rate of complete remission (CR) and CR with incomplete platelet recovery (CRp), was the primary end point of the study, with additional analyses of survival time and toxicity. RESULTS: A total of 191 patients were randomly assigned from November 1999 to April 2001. The percent CR plus CRp with MEC plus lintuzumab was 36% v 28% in patients treated with MEC alone (P = .28). The overall median survival was 156 days and was not different in the two arms of the study. Apart from mild antibody infusion-related toxicities (fever, chills, and hypotension), no differences in chemotherapy-related adverse effects, including hepatic and cardiac dysfunction, were observed with the addition of lintuzumab to induction chemotherapy. CONCLUSION: The addition of lintuzumab to salvage induction chemotherapy was safe, but did not result in a statistically significant improvement in response rate or survival in patients with refractory/relapsed AML.