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Influencing Side-Effects to Medicinal Treatments: A Systematic Review of Brief Psychological Interventions.

ABSTRACT: Background: Nocebo effects contribute to a large proportion of the non-specific side-effects attributed to medications and are mainly generated through negative expectations. Previous reviews show that interventions designed to change participants' expectations have a small effect on pain experience. They are also effective in reducing side-effects caused by exposure to sham medications. To date, there has been no review of the influence of such interventions on symptoms attributed to real medicinal treatments. Objective: To review studies using a randomized controlled design testing the effect of brief psychological interventions compared to usual practice on the side-effect experience to medicinal treatments in healthy volunteers and patients. Methods: We searched Web of Science, Scopus, Medline, PsycINFO, PsycARTICLES, and Cochrane CENTRAL using search terms for randomized controlled trials along with "nocebo," "placebo effect," "medication," "side-effects," and associated terms. Studies were eligible if they studied a human population, used an active medicine, delivered a brief psychological intervention intended to influence side-effect reporting compared to usual care or no intervention, and used a randomized controlled design. Because of the heterogeneity of the literature we used a narrative synthesis and assessed evidence quality using the GRADE approach. Results: Our database search and supplementary search of the reference sections of included studies retrieved 50,140 citations. After screening, full text review and manual reference searches, 27 studies were included. The quality of the studies and evidence was judged to be low. The strongest and most consistent effect came from omitting side-effect information, although surprisingly de-emphasizing side-effects did not affect side-effect reporting. Other techniques, including priming, distraction, and altering the perception of branding, produced mixed results. Conclusion: Brief psychological interventions can influence side-effect reporting to active medications. Research is currently investigating new ways to de-emphasize side-effects whilst still upholding informed consent, but larger confirmatory trials with suitable control groups are needed. The literature in this area would be improved by more detailed reporting of studies.

SUBMITTER: Webster RK

PROVIDER: S-EPMC6371736 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Influencing Side-Effects to Medicinal Treatments: A Systematic Review of Brief Psychological Interventions.

Webster Rebecca K RK Rubin G James GJ

Frontiers in psychiatry 20190205

<b>Background:</b> Nocebo effects contribute to a large proportion of the non-specific side-effects attributed to medications and are mainly generated through negative expectations. Previous reviews show that interventions designed to change participants' expectations have a small effect on pain experience. They are also effective in reducing side-effects caused by exposure to sham medications. To date, there has been no review of the influence of such interventions on symptoms attributed to rea ...[more]

PMID: 30804822

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Project description:BACKGROUND:Every year, more than 800,000 people worldwide die by suicide. The aim of this study was to conduct a systematic review of the effectiveness of brief psychological interventions in addressing suicidal thoughts and behaviour in healthcare settings. METHODS:Following PRISMA guidelines, systematic searches were conducted in MEDLINE, CINAHL, EMBASE, the Cochrane Central Register of Controlled Trials and PsycINFO databases. A predefined search strategy was used. Two independent reviewers screened titles and abstracts followed by full texts against predefined inclusion criteria. Backward and forward citation tracking of included papers was conducted. Quality appraisal was conducted using the Cochrane Risk of Bias Tool for Randomized Controlled Trials and the CASP tool for randomised controlled trials. The small number and heterogeneity of studies did not allow for meta-analysis to be conducted. A narrative synthesis was conducted. RESULTS:Four controlled studies of brief psychological interventions were included, conducted in Switzerland, the U.S. and across low and middle-income countries. Three studies were conducted with adults and one with adolescents. All studies were judged to be at low risk of bias. All of the interventions were implemented with patients after attending emergency departments and involved 3412 participants. The main outcomes were suicide, suicide attempts, suicidal ideation, depression and hospitalization. The components of the interventions were early therapeutic engagement, information provision, safety planning and follow-up contact for at least 12 months. The interventions drew to, different degrees, on psychological theory and techniques. Two trials that measured suicidal ideation found no impact. Two studies showed fewer suicide attempts, one showed fewer suicides and one found an effect on depression. CONCLUSIONS:Although the evidence base is small, brief psychological interventions appear to be effective in reducing suicide and suicide attempts. All studies to date have been conducted with people who had attended the ED but the interventions could potentially be adopted for inpatient and other outpatient settings. Early engagement and therapeutic intervention based on psychological theories of suicidal behaviour, sustained in follow-up contacts, may be particularly beneficial. TRIAL REGISTRATION:Systematic review registration: PROSPERO CRD42015025867.

Project description:Background: The increasing number of stroke patients (SPs) requires informal caregivers to bear a high burden of responsibilities and heavy (di)stress. Moreover, these issues could lead to the development of serious psychological problems (e.g., depressive and/or anxious) that in turn could give rise to poor health-related quality of life outcomes. However, although the value of psychological interventions has been widely recognized for SPs, the scientific literature lacks an updated synthesis of interventions addressing the psychological health of their caregivers. Aim: The aim of this review is to summarize the interventions for the psychological health of stroke caregivers and provide a resume of literature-based evidence of their efficacy. Method: A literature review from 2005 to date was conducted in three online databases: PubMed, Scopus, and Google Scholar. Eligibility criteria for studies were (A) English language, (B) caregivers and patients aged 18 years or above, (C) SP's caregiver beneficiating of a specific intervention, and (D) outcome measures addressing depressive and/or anxiety symptomology, quality of life, well-being, or burden. Results: Across the selected 45 studies, substantial differences are observable in three main categories: (a) type of intervention (b) techniques, and (c) operators. Interventions' advantages and results are discussed. Overall, studies using psychological techniques, such as cognitive-behavioral therapy, coping skill-training, and problem-solving therapy, showed their usefulness and efficacy in reducing the caregivers' depressive and anxious symptoms, and burden. Interventions led by psychologists and tailored to meet caregivers' specific needs showed more positive outcomes. Conclusion: This review underlines the usefulness of psychological interventions aimed at reducing the psychological burden, such as anxious and depressive symptomatology, of SPs' informal caregivers. Hence, psychological interventions for caregivers should be integrated as part of the stroke rehabilitation process to improve informal caregivers' and patients' quality of life and well-being.

Project description:BackgroundCardiovascular disease (CVD) risk communication is a challenge for clinical practice, where physicians find it difficult to explain the absolute risk of a CVD event to patients with varying health literacy. Converting the probability to heart age is increasingly used to promote lifestyle change, but a rapid review of biological age interventions found no clear evidence that they motivate behavior change.ObjectiveIn this review, we aim to identify the content and effects of heart age interventions.MethodsWe conducted a systematic review of studies presenting heart age interventions to adults for CVD risk communication in April 2020 (later updated in March 2021). The Johanna Briggs risk of bias assessment tool was applied to randomized studies. Behavior change techniques described in the intervention methods were coded.ResultsFrom a total of 7926 results, 16 eligible studies were identified; these included 5 randomized web-based experiments, 5 randomized clinical trials, 2 mixed methods studies with quantitative outcomes, and 4 studies with qualitative analysis. Direct comparisons between heart age and absolute risk in the 5 web-based experiments, comprising 5514 consumers, found that heart age increased positive or negative emotional responses (4/5 studies), increased risk perception (4/5 studies; but not necessarily more accurate) and recall (4/4 studies), reduced credibility (2/3 studies), and generally had no effect on lifestyle intentions (4/5 studies). One study compared heart age and absolute risk to fitness age and found reduced lifestyle intentions for fitness age. Heart age combined with additional strategies (eg, in-person or phone counseling) in applied settings for 9582 patients improved risk control (eg, reduced cholesterol levels and absolute risk) compared with usual care in most trials (4/5 studies) up to 1 year. However, clinical outcomes were no different when directly compared with absolute risk (1/1 study). Mixed methods studies identified consultation time and content as important outcomes in actual consultations using heart age tools. There were differences between people receiving an older heart age result and those receiving a younger or equal to current heart age result. The heart age interventions included a wide range of behavior change techniques, and conclusions were sometimes biased in favor of heart age with insufficient supporting evidence. The risk of bias assessment indicated issues with all randomized clinical trials.ConclusionsThe findings of this review provide little evidence that heart age motivates lifestyle behavior change more than absolute risk, but either format can improve clinical outcomes when combined with other behavior change strategies. The label for the heart age concept can affect outcomes and should be pretested with the intended audience. Future research should consider consultation time and differentiate between results of older and younger heart age.International registered report identifier (irrid)NPRR2-10.1101/2020.05.03.20089938.

Project description:BackgroundEvidence on technology-based psychological interventions (TBIs) for the treatment of depression is rapidly growing and covers a broad scope of research. Despite extensive research in this field, guideline recommendations are still limited to the general effectiveness of TBIs.ObjectiveThis study aims to structure evidence on TBIs by considering different application areas (eg, TBIs for acute treatment and their implementation in health care, such as stand-alone interventions) and treatment characteristics (eg, therapeutic rationale of TBIs) to provide a comprehensive evidence base and to identify research gaps in TBIs for diagnosed depression. Moreover, the reporting of negative events in the included studies is investigated in this review to enable subsequent safety assessment of the TBIs.MethodsRandomized controlled trials on adults diagnosed with unipolar depression receiving any kind of psychotherapeutic treatment, which was at least partly delivered by a technical medium, were eligible for inclusion in our preregistered systematic review. We searched for trials in CENTRAL (Cochrane Central Register of Controlled Trials; until August 2020), MEDLINE, PsycINFO, PSYNDEX, CINAHL; until the end of January 2018), clinical trial registers, and sources of gray literature (until the end of January 2019). Study selection and data extraction were conducted by 2 review authors independently.ResultsDatabase searches resulted in 15,546 records, of which 241 publications were included, representing 83 completed studies and 60 studies awaiting classification (ie, preregistered studies, study protocols). Almost all completed studies (78/83, 94%) addressed the acute treatment phase, being largely either implemented as stand-alone interventions (66/83, 80%) or blended treatment approaches (12/83, 14%). Studies on TBIs for aftercare (4/83, 5%) and for bridging waiting periods (1/83, 1%) were scarce. Most TBI study arms (n=107) were guided (59/107, 55.1%), delivered via the internet (80/107, 74.8%), and based on cognitive behavioral treatment approaches (88/107, 79.4%). Almost all studies (77/83, 93%) reported information on negative events, considering dropouts from treatment as a negative event. However, reports on negative events were heterogeneous and largely unsystematic.ConclusionsResearch has given little attention to studies evaluating TBIs for aftercare and for bridging waiting periods in people with depression, even though TBIs are seen as highly promising in these application areas; thus, high quality studies are urgently needed. In addition, the variety of therapeutic rationales on TBIs has barely been represented by identified studies hindering the consideration of patient preferences when planning treatment. Finally, future studies should use specific guidelines to systematically assess and report negative events.Trial registrationInternational Prospective Register of Systematic Reviews (PROSPERO) CRD42016050413; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42016050413.International registered report identifier (irrid)RR2-10.1136/bmjopen-2018-028042.

Project description:ObjectiveNonsuicidal self-injury (NSSI), the deliberate, self-inflicted damage of bodily tissue without the intent to die, is associated with various negative outcomes. Although basic and epidemiologic research on NSSI has increased during the last 2 decades, literature on effective interventions targeting NSSI is still emerging. Here, we present a comprehensive, systematic review of existing psychological and pharmacological treatments designed specifically for NSSI, or including outcome assessments examining change in NSSI.MethodWe conducted a systematic search of PsycINFO, MEDLINE, and ERIC databases to retrieve relevant articles that met inclusion criteria; specifically, uncontrolled and controlled trials that 1) presented quantitative outcome data on NSSI, and 2) clearly differentiated NSSI from suicidal self-injury (SSI). Consistent with the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, definition of NSSI, we excluded studies examining populations with developmental or intellectual disabilities, or with psychotic disorders.ResultsSeveral interventions appear to hold promise for reducing NSSI, including dialectical behaviour therapy, emotion regulation group therapy, manual-assisted cognitive therapy, dynamic deconstructive psychotherapy, atypical antipsychotics (aripiprazole), naltrexone, and selective serotonin reuptake inhibitors (with or without cognitive-behavioural therapy). Nevertheless, there remains a paucity of well-controlled studies investigating treatment efficacy for NSSI.ConclusionsStructured psychotherapeutic approaches focusing on collaborative therapeutic relationships, motivation for change, and directly addressing NSSI behaviours seem to be most effective in reducing NSSI. Medications targeting the serotonergic, dopaminergic and opioid systems also have demonstrated some benefits. Future studies employing controlled designs as well as a clear delineation of NSSI and SSI will improve knowledge regarding treatment effects.

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Influencing Side-Effects to Medicinal Treatments: A Systematic Review of Brief Psychological Interventions.

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Influencing Side-Effects to Medicinal Treatments: A Systematic Review of Brief Psychological Interventions.

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