Correction: Accelerating the development of a psychological intervention to restore treatment decision‑making capacity in patients with schizophrenia‑spectrum disorder: a study protocol for a multi‑site, assessor‑blinded, pilot Umbrella trial (the DEC:IDES trial).
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SUBMITTER: Hutton P
PROVIDER: S-EPMC10424412 | biostudies-literature | 2023 Aug
REPOSITORIES: biostudies-literature
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Correction: Accelerating the development of a psychological intervention to restore treatment decision‑making capacity in patients with schizophrenia‑spectrum disorder: a study protocol for a multi‑site, assessor‑blinded, pilot Umbrella trial (the DEC:IDES trial).
Hutton Paul P Kelly James J Taylor Christopher D J CDJ Williams Brian B Emsley Richard R Alexander Candy Ho CH Vikram Anvita A Saddington David D McCann Andrea A Burke Joseph J Eliasson Emma E Harper Sean S Karatzias Thanos T Taylor Peter J PJ Watson Andrew A Dougall Nadine N Stavert Jill J O'Rourke Suzanne S Glasgow Angela A Murphy Regina R Palmer Karen K Zaidi Nosheen N Bidwell Polly P Pritchard Jemma J Carr Lucy L Woodrow Amanda A
Pilot and feasibility studies 20230814 1
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Project description:BackgroundA high proportion of patients diagnosed with schizophrenia-spectrum disorders will at some point in their lives be assessed as not having the capacity to make their own decisions about pharmacological treatment or inpatient care ('capacity'). Few will be helped to regain it before these interventions proceed. This is partly because effective and safe methods to do so are lacking. Our aim is to accelerate their development by testing, for the first time in mental healthcare, the feasibility, acceptability and safety of running an 'Umbrella' trial. This involves running, concurrently and under one multi-site infrastructure, multiple assessor-blind randomised controlled trials, each of which is designed to examine the effect on capacity of improving a single psychological mechanism ('mechanism'). Our primary objectives are to demonstrate feasibility of (i) recruitment and (ii) data retention on the MacArthur Competence Assessment Tool-Treatment (MacCAT-T; planned primary outcome for a future trial) at end-of-treatment. We selected three mechanisms to test: 'self-stigma', low self-esteem and the 'jumping to conclusions' bias. Each is highly prevalent in psychosis, responsive to psychological intervention, and hypothesised to contribute to impaired capacity.MethodsSixty participants with schizophrenia-spectrum diagnoses, impaired capacity and one or more mechanism(s) will be recruited from outpatient and inpatient mental health services in three UK sites (Lothian, Scotland; Lancashire and Pennine; North West England). Those lacking capacity to consent to research could take part if the key criteria were met, including either proxy consent (Scotland) or favourable Consultee advice (England). They will be allocated to one of three randomised controlled trials, depending on which mechanism(s) they have. They will then be randomised to receive, over an 8-week period and in addition to treatment as usual (TAU), 6 sessions of either a psychological intervention which targets the mechanism, or 6 sessions of assessment of the causes of their incapacity (control condition). Participants are assessed at 0 (baseline), 8 (end-of-treatment) and 24 (follow-up) weeks post-randomisation using measures of capacity (MacCAT-T), mechanism, adverse events, psychotic symptoms, subjective recovery, quality of life, service use, anxiety, core schemata and depression. Two nested qualitative studies will be conducted; one to understand participant and clinician experiences and one to investigate the validity of MacCAT-T appreciation ratings.DiscussionThis will be the first Umbrella trial in mental healthcare. It will produce the first 3 single-blind randomised controlled trials of psychological interventions to support treatment decision-making in schizophrenia-spectrum disorder. Demonstrating feasibility will have significant implications not only for those seeking to support capacity in psychosis, but also for those who wish to accelerate the development of psychological interventions for other conditions.Trial registrationClinicalTrials.gov NCT04309435 . Pre-registered on 16 March 2020.
| S-EPMC10329297 | biostudies-literature
Project description:BackgroundCentral obesity is considered as a significant health threat to individuals. Scientific research has demonstrated that intra-abdominal fat accumulation is associated with higher metabolic and cardiovascular disease risks independent of Body Mass Index (BMI). This study aimed to evaluate the efficacy and safety of electro-acupuncture in treating central obesity compared with sham acupuncture.MethodThis was a patient-assessor blinded, randomized, sham-controlled clinical trial. One hundred sixty eight participants aged between 18 and 65 years old with BMI ≥ 25 kg/m2 and waist circumference (WC) of men ≥ 90 cm / women ≥ 80 cm were enrolled and allocated to the acupuncture or sham acupuncture group equally. For the acupuncture group, disposable acupuncture needles were inserted into eight body acupoints, including Tianshu (ST-25), Daheng (SP-15), Daimai (GB-26), Qihai (CV-6), Zhongwan (CV-12), Zusanli (ST-36), Fenglong (ST-40), and Sanyinjiao (SP-6) with electrical stimulation. For the control group, Streitberger's non-invasive acupuncture needles were utilized at the same acupoints with identical stimulation modalities. The treatment duration was 8 weeks with 2 sessions per week and the follow-up period was 8 weeks. The primary outcome was the change in WC before and after the treatment. The secondary outcomes were the changes in hip circumference, waist-to-hip circumference ratio, BMI, and body fat percentage during the treatment and follow-up period.ResultsThe acupuncture group displayed a significant change in WC compared to the sham group both treatment and follow-up period (MD = -1.1 cm, 95% CI = -2.8 to 4.1). Significant change in body fat percentage was recorded for both groups after treatment but no significance was observed during the follow-up period (MD = -0.1%, 95% CI = -1.9 to 2.2). The changes in hip circumference were also significant both treatment and follow-up period for the acupuncture group (MD = -2.0 cm, 95% CI = -3.7 to -1.7). Compared with sham acupuncture, the body weight (MD = -1 kg, 95% CI = -3.3 to 5.3), BMI (MD = -0.5, 95% CI = -0.7 to 1.9) also decreased significantly within and between groups. The incidence of adverse events was similar in the two groups.ConclusionThis study provided evidence that electro-acupuncture could be effective in treating central obesity by reducing WC, hip circumference, body weight, BMI, and waist-to-hip circumference ratio.Trial registrationClinicalTrials.gov Identifier: NCT03815253, Registered 24 Jan 2019.
| S-EPMC10823622 | biostudies-literature
Project description:Cancer-related fatigue (CRF) is one of the most common chronic symptoms experienced by cancer patients. As moxibustion is a popular traditional therapy for managing fatigue, it can be an alternative strategy to treat CRF as well. Therefore, we rigorously designed a full-scale, multicenter, assessor-blinded, randomized controlled trial to evaluate the efficacy and safety of moxibustion treatment for CRF. Ninety-six subjects suffering from CRF were recruited and randomly assigned to moxibustion group, sham moxibustion group, or usual care group. Both the moxibustion group and the sham group received moxibustion treatment for 8 weeks and the usual care group did not. Brief fatigue inventory (BFI) score and Functional Assessment of Cancer Therapy-Fatigue score were used to assess CRF at baseline and weeks 5, 9, and 13. Questionnaires for the assessment of cognitive impairment, quality of life, and Cold-Heat and Deficiency-Excess patterns were also evaluated. BFI scores significantly decreased in moxibustion group compared to the usual care group (mean difference of -1.92, p < 0.001 at week 9 and mean difference of -2.36, p < 0.001 at week 13). Although the sham group also showed significant improvement during the treatment period, only the moxibustion group showed improvement after 4 weeks of follow-up period (mean difference of -1.06, p < 0.001). There were no serious adverse events. Our findings confirmed the efficacy and safety of moxibustion for CRF compared to usual care. We also found that moxibustion has a prolonged treatment effect during 4 weeks of follow-up period.
| S-EPMC8290232 | biostudies-literature
Project description:BackgroundAlthough clozapine is the treatment of choice for treatment-refractory schizophrenia, 30-40% of patients have an insufficient response, and others are unable to tolerate it. Evidence for any augmentation strategies is scarce. We aimed to determine whether cognitive behavioural therapy (CBT) is an effective treatment for clozapine-resistant schizophrenia.MethodsWe did a pragmatic, parallel group, assessor-blinded, randomised controlled trial in community-based and inpatient mental health services in five sites in the UK. Patients with schizophrenia who were unable to tolerate clozapine, or whose symptoms did not respond to the drug, were randomly assigned 1:1 by use of randomised-permuted blocks of size four or six, stratified by centre, to either CBT plus treatment as usual or treatment as usual alone. Research assistants were masked to allocation to protect against rater bias and allegiance bias. The primary outcome was the Positive and Negative Syndrome Scale (PANSS) total score at 21 months, which provides a continuous measure of symptoms of schizophrenia; PANSS total was also assessed at the end of treatment (9 months). The primary analysis was by randomised treatment based on intention to treat, for all patients for whom data were available. This study was prospectively registered, number ISRCTN99672552. The trial is closed to accrual.FindingsFrom Jan 1, 2013, to May 31, 2015, we randomly assigned 487 participants to either CBT and treatment as usual (n=242) or treatment as usual alone (n=245). Analysis included 209 in the CBT group and 216 in the treatment as usual group. No difference occurred in the primary outcome (PANSS total at 21 months, mean difference -0·89, 95% CI -3·32 to 1·55; p=0·48), although the CBT group improved at the end of treatment (PANSS total at 9 months, mean difference -2·40, -4·79 to -0·02; p=0·049). During the trial, 107 (44%) of 242 participants in the CBT arm and 104 (42%) of 245 in the treatment as usual arm had at least one adverse event (odds ratio 1·09, 95% CI 0·81 to 1·46; p=0·58). Only two (1%) of 242 participants in the CBT arm and one (<1%) of 245 in the treatment as usual arm had a trial-related serious adverse event.InterpretationAt 21-month follow-up, CBT did not have a lasting effect on total symptoms of schizophrenia compared with treatment as usual; however, CBT produced statistically, though not clinically, significant improvements on total symptoms by the end of treatment. There was no indication that the addition of CBT to treatment as usual caused adverse effects. The results of this trial do not support a recommendation to routinely offer CBT to all people who meet criteria for clozapine-resistant schizophrenia; however, a pragmatic individual trial might be indicated for some.FundingNational Institute for Health Research Technology Assessment programme.
| S-EPMC6063993 | biostudies-literature
Project description:BackgroundObesity is a common medical condition. Among all the classifications of obesity, central obesity is considered to be a significant threat on the health of individuals. Scientific researches have demonstrated that the accumulation of intra-abdominal fat is associated with higher metabolic and cardiovascular disease risks independently from Body Mass Index (BMI). Our previous research found that the combination of electro-acupuncture and auricular acupressure could significantly reduce the body weight and the BMI compared to sham control group.Methods/designThis is a patient-assessor blinded, randomized, sham-controlled clinical trial on electro-acupuncture for central obesity. One hundred sixty-eight participants with central obesity will be randomly assigned to two groups, which are the acupuncture group and the sham control group. The whole study duration will be 8-week treatment plus 8-week follow up. The primary outcome is the change in waist circumference before and after the treatment. The secondary outcomes include the changes in hip circumference, waist-to-hip circumference ratio, BMI and body fat percentage during the treatment and follow-up.ConclusionThe trial will evaluate the efficacy and safety of electro-acupuncture for central obesity compared with sham acupuncture. The study may provide the solid evidence of electro-acupuncture on central obesity in Hong Kong.Trial registrationClinicalTrials.gov Identifier: NCT03815253 ,Registered 24 Jan 2019.
| S-EPMC8254909 | biostudies-literature
Project description:BackgroundMeta-analyses of nonrandomized studies have provided conflicting data on therapeutic hypothermia, or targeted temperature management (TTM), at 33°C in patients successfully resuscitated after nonshockable cardiac arrest. Nevertheless, the latest recommendations issued by the International Liaison Committee on Resuscitation and by the European Resuscitation Council recommend therapeutic hypothermia. New data are available on the adverse effects of therapeutic hypothermia, notably infectious complications. The risk/benefit ratio of therapeutic hypothermia after nonshockable cardiac arrest is unclear.MethodsHYPERION is a multicenter (22 French ICUs) trial with blinded outcome assessment in which 584 patients with successfully resuscitated nonshockable cardiac arrest are allocated at random to either TTM between 32.5 and 33.5°C (therapeutic hypothermia) or TTM between 36.5 and 37.5°C (therapeutic normothermia) for 24 hours. Both groups are managed with therapeutic normothermia for the next 24 hours. TTM is achieved using locally available equipment. The primary outcome is day-90 neurological status assessed by the Cerebral Performance Categories (CPC) Scale with dichotomization of the results (1 + 2 versus 3 + 4 + 5). The primary outcome is assessed by a blinded psychologist during a semi-structured telephone interview of the patient or next of kin. Secondary outcomes are day-90 mortality, hospital mortality, severe adverse events, infections, and neurocognitive performance. The planned sample size of 584 patients will enable us to detect a 9% absolute difference in day-90 neurological status with 80% power, assuming a 14% event rate in the control group and a two-sided Type 1 error rate of 4.9%. Two interim analyses will be performed, after inclusion of 200 and 400 patients, respectively.DiscussionThe HYPERION trial is a multicenter, randomized, controlled, assessor-blinded, superiority trial that may provide an answer to an issue of everyday relevance, namely, whether TTM is beneficial in comatose patients resuscitated after nonshockable cardiac arrest. Furthermore, it will provide new data on the tolerance and adverse events (especially infectious complications) of TTM at 32.5-33.5°C.Trial registrationClinicalTrials.gov: NCT01994772 .
| S-EPMC4353458 | biostudies-literature
Project description:BackgroundInsomnia is one of the most frequent symptoms in people with cancer. Electroacupuncture has been widely used in people with cancer or insomnia. We explored the feasibility and preliminary effectiveness of electroacupuncture for cancer-related insomnia.MethodsPeople with cancer and insomnia disorder were randomly allocated to electroacupuncture, sham-electroacupuncture, or usual care groups. Participants received either 10 sessions of electroacupuncture at real acupoints, sham-electroacupuncture at non-acupoints, or usual care in each group for 4 weeks. We calculated the recruitment, adherence, and completion rates of participants. The Insomnia Severity Index (ISI), Pittsburgh Sleep Quality Index (PSQI), sleep diary and actigraphy-derived sleep parameters, Functional Assessment of Cancer Therapy-Fatigue (FACT-F), Montreal Cognitive Assessment (MoCA), and salivary levels of cortisol and melatonin were evaluated as outcome measures.ResultsTwenty-two participants were enrolled (8, 6, and 8 respectively in the electroacupuncture, sham-electroacupuncture, and usual care groups) and 20 participants completed the trials (8, 4, and 8 respectively). The recruitment, adherence, and completion rates were 78.57% (22/28), 95.45% (21/22), and 90.91% (20/22), respectively. Most of the participants had previously received conventional treatment for insomnia, but few had received Korean medicine treatment, without any demographic or clinical differences between groups. In the electroacupuncture group, there was a statistically significant reduction of 10.13 (mean) ± 8.15 (standard deviation) and 5 ± 3.70 points in mean ISI and PSQI scores at 4 weeks post-treatment (P = .0098 and .0066), compared with sham-electroacupuncture (2.06 ± 7.15 and 1.61 ± 4.34; P = .4796 and .3632) and usual care (3.25 ± 2.60 and 1.38 ± 2.13; P = .0096 and .1112). Although there was no significant difference in ISI score between groups at 4 weeks post-treatment, the electroacupuncture group continued to improve significantly at 4 weeks' follow-up, showing borderline and significant differences compared to the sham-electroacupuncture and usual care (P = .0614 and .0015). The FACT-F scores in electroacupuncture group showed a significant improvement compared with the sham-electroacupuncture group (P = .0305). No electroacupuncture-related adverse events were reported.ConclusionsElectroacupuncture might be feasible for cancer-related insomnia, despite slow participant recruitment. Additional trials with adequately powered sample sizes and a substantial change to the recruitment procedure are needed.Trial registrationClinical Research Information Service, KCT0002162 . Submitted 27 October 2016, Registered 2 December 2016 - Retrospectively registered (The first participant enrolment: 28 November 2016).
| S-EPMC8932204 | biostudies-literature
Project description:BackgroundShared decision-making (SDM) is a process aimed at facilitating patient-centered care by ensuring that the patient and provider are actively involved in treatment decisions. In mental health care, SDM has been advocated as a means for the patient to gain or regain control and responsibility over their life and recovery process. To support the process of patient-centered care and SDM, digital tools may have advantages in terms of accessibility, structure, and reminders.ObjectiveIn this randomized controlled trial, we aimed to investigate the effect of a digital tool to support patient activation and SDM.MethodsThe trial was designed as a randomized, assessor-blinded, 2-armed, parallel-group multicenter trial investigating the use of a digital SDM intervention for 6 months compared with treatment as usual. Participants with a diagnosis of schizophrenia, schizotypal or delusional disorder were recruited from 9 outpatient treatment sites in the Capital Region of Denmark. The primary outcome was the self-reported level of activation at the postintervention time point. The secondary outcomes included self-efficacy, hope, working alliance, satisfaction, preparedness for treatment consultation, symptom severity, and level of functioning. Explorative outcomes on the effect of the intervention at the midintervention time point along with objective data on the use of the digital tool were collected.ResultsIn total, 194 participants were included. The intention-to-treat analysis revealed a statistically significant effect favoring the intervention group on patient activation (mean difference 4.39, 95% CI 0.99-7.79; Cohen d=0.33; P=.01), confidence in communicating with one's provider (mean difference 1.85, 95% CI 0.01-3.69; Cohen d=0.24; P=.05), and feeling prepared for decision-making (mean difference 5.12, 95% CI 0.16-10.08; Cohen d=0.27; P=.04). We found no effect of the digital SDM tool on treatment satisfaction, hope, self-efficacy, working alliance, severity of symptoms, level of functioning, use of antipsychotic medicine, and number or length of psychiatric hospital admissions.ConclusionsThis trial showed a significant effect of a digital SDM tool on the subjective level of patient activation, confidence in communicating with one's provider, and feeling prepared for decision-making at the postintervention time point. The effect size was smaller than the 0.42 effect size that we had anticipated and sampled for. The trial contributes to the evidence on how digital tools may support patient-centered care and SDM in mental health care.Trial registrationClinicalTrials.gov NCT03554655; https://clinicaltrials.gov/ct2/show/NCT03554655.International registered report identifier (irrid)RR2-doi: 10.1186/s12888-019-2143-2.
| S-EPMC9647453 | biostudies-literature
Project description:IntroductionA considerable number of insomnia patients experience sleep disturbance even with long-term use of hypnotic medication. Previous studies have indicated that electroacupuncture (EA) could be an efficacious treatment for managing insomnia. However, few trials have been conducted to evaluate the effectiveness and safety of EA for treatment-resistant insomnia. This pilot study aims to explore the feasibility and preliminary effectiveness and safety of EA as an adjunct treatment for treatment-resistant insomnia.Methods and analysisThis is a multicentre, randomised, usual care controlled and assessor-blinded pilot study protocol. Fifty patients presenting with sleep problems who have been taking hypnotic medication for more than 3 months will be randomly allocated to either an EA group or a usual care group at a 1:1 ratio. The EA group will undergo 12 EA treatment sessions twice a week for 6 weeks whereas the usual care group will not receive EA treatment. All the participants will receive a brochure containing educational information on sleep hygiene. The primary outcome will be the measured mean change of the total score of the Insomnia Severity Index from the baseline to week 7. The secondary outcome regarding sleep quality will be measured using the Pittsburgh Sleep Quality Index, a sleep diary and actigraphy. Moreover, we will assess the quality of life, the direct and indirect cost of treating insomnia for economic evaluation. After 4 weeks, the subjects will visit the research sites for a follow-up assessment.Ethics and disseminationEthical approval of this study protocol was established by the institutional review boards of the each involved study site. All potential subjects will be provided written informed consent. The results of this study will be accessible in peer-reviewed publications and be presented at academic conference.Trial registration numberKCT0003235.
| S-EPMC7202710 | biostudies-literature
Project description:Insomnia is a highly prevalent symptom occurred during and post-chemotherapy. Acupuncture may have beneficial effects in the management of chemotherapy-associated insomnia. This study was conducted to determine the efficacy and safety of acupuncture in improving chemotherapy-associated insomnia in breast cancer patients. This assessor-participant blinded, randomized, sham-controlled trial was conducted from November 2019 to January 2022 (follow-up completed July 2022). Participants were referred by oncologists from two Hong Kong hospitals. Assessments and interventions were conducted at the outpatient clinic of School of Chinese Medicine, the University of Hong Kong. The 138 breast cancer patients with chemotherapy-associated insomnia were randomly assigned to receive either 15 sessions of active acupuncture regimen by combining needling into body acupoints and acupressure on auricular acupoints or sham acupuncture control (69 each) for 18 weeks, followed by 24 weeks of follow-up. The primary outcome was measured using Insomnia Severity Index (ISI). Secondary outcomes included the Pittsburgh Sleep Quality Index, Actiwatch and sleep diary for sleep parameters, depression and anxiety, fatigue and pain, and quality of life. There were 87.7% (121/138) participants who completed the primary endpoint (week-6). The active acupuncture regimen was not superior to the sham control in reducing ISI score from baseline to 6 weeks (mean difference: - 0.4, 95% CI - 1.8-1.1; P = 0.609), but produced short-term treatment and long-term follow-up better outcomes in improving sleep onset latency, total sleep time, sleep efficiency, anxiety, depression, and quality of life. Participants of the active acupuncture group had a pronouncedly higher cessation rate of sleeping medications than the sham control (56.5% vs. 14.3%, P = 0.011). All treatment-related adverse events were mild. No participants discontinued treatments due to adverse events. The active acupuncture regimen could be considered as an effective option for the management of chemotherapy-associated insomnia. It also could serve as a tapering approach to reduce and even replace the use of sleeping medications in breast cancer patients. Trial registration Clinicaltrials.gov : NCT04144309. Registered 30 October 2019.
| S-EPMC10134666 | biostudies-literature