BackgroundThe aim of the TAILOR trial is to investigate the effect of closely monitored tapering/discontinuation versus maintenance therapy with antipsychotic medication in patients with newly diagnosed schizophrenia or persistent delusional disorder and with minimum 3 months’ remission of psychotic symptoms.Methods and designTwo hundred and fifty patients will be included from the psychiatric early intervention program, OPUS, in two regions in Denmark. Inclusion criteria are: ICD-10 diagnoses schizophrenia (F20, except F20.6) or persistent delusional disorder (F22), minimum 3 months’ remission of psychotic symptoms and in treatment with antipsychotic medication (except clozapine). The patients will be randomized to maintenance therapy or tapering/discontinuation with antipsychotic medication in a 1-year intervention. The tapering/discontinuation group will be using a smartphone application to monitor early warning signs of psychotic relapse. Patients will be assessed at baseline, 1-, 2- and 5-year follow-up regarding psychotic and negative symptoms, side-effects of antipsychotic medication, social functioning, cognitive functioning, perceived health status, patient satisfaction, substance and alcohol use, sexual functioning and quality of life. The primary outcome will be remission of psychotic symptoms and no antipsychotic medication after 1 year. Secondary outcome measures will include: co-occurrence of remission of psychotic symptoms and 0–1-mg haloperidol equivalents of antipsychotic medication after 1-year intervention; antipsychotic dose; antipsychotic side effects; negative symptoms; social functioning; cognitive functioning; and patient satisfaction. Exploratory outcomes will include remission, clinical recovery, substance and alcohol use, sexual functioning, quality of life, self-beliefs of coping and user experience of support from health workers. Safety measures will include death, admissions to psychiatric hospital, severe self-harm and psychotic relapses.DiscussionThe TAILOR trial will contribute knowledge about the effect of tapering/discontinuation of antipsychotic medication in the early phases of schizophrenia and related disorders and the results may guide future clinical treatment regimens of antipsychotic treatment.Trial registrationEU Clinical Trials Register – EudraCT number: 2016-000565-23. Registered on 5 February 2016.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-2172-4) contains supplementary material, which is available to authorized users.
AimEvidence is insufficient regarding the consequences of discontinuing vs. maintaining antipsychotic medication in patients with first-episode schizophrenia. Our aim was to examine tapered discontinuation vs. maintenance treatment regarding remission of psychotic symptoms and impact on other areas.MethodsPatients included had a diagnosis of schizophrenia, were treated with antipsychotic medication, and were in remission of psychotic symptoms. Participants were randomized to tapered discontinuation or maintenance treatment with antipsychotic medication. Assessments were undertaken at baseline and after 1-year. The primary outcome was remission of psychotic symptoms without antipsychotic medication.ResultsThe trial was terminated due to insufficient recruitment. In total, 29 participants were included: 14 in the tapering/discontinuation group and 15 in the maintenance group. Adherence to maintenance treatment was poor. At 1-year follow-up, remission of psychotic symptoms without antipsychotic medication for 3 months was observed in five participants in the tapering/discontinuation group and two in the maintenance group.ConclusionDue to insufficient recruitment this study does not provide a conclusion on whether unfavorable outcomes or advantages follow tapering of antipsychotic medication. Recruitment and adherence to maintenance treatment encountered obstacles. Based on experiences from this trial, we discussed alternative study designs as consistent evidence is still needed on whether to continue or discontinue antipsychotic medication in remitted patients with first-episode schizophrenia.Clinical trial registrationhttps://www.clinicaltrialsregister.eu/ctr-search/trial/2016-000565-23/DK, EU Clinical Trials Register—EudraCT no. 2016–000565–23.
Mental healthcare providers face many difficult interactions with patients that can be emotionally demanding and have adverse effects on their well-being. Recent theoretical models suggest that the interpretation of stressful episodes may be more important for psychological adjustment than the nature of the episodes. This study examined whether care providers' interpretations of mechanical restraint episodes were related to their adjustment. We asked 80 mental healthcare providers to recall mechanical restraint episodes and to rate them on centrality to identity and positive and negative influence on self-understanding. They also completed scales measuring current symptoms of post-traumatic stress, depression, life satisfaction, and well-being. The results showed that care providers who interpreted mechanical restraint episodes as having a central negative influence on their identity experienced more symptoms of post-traumatic stress. Care providers who gave higher ratings of positive self-change following episodes reported more well-being. Our findings suggest, that considering care providers' subjective interpretations of episodes and not merely the objective facts surrounding them is critical if we wish to mitigate the negative emotional impact of episodes. K E Y W O R D Sevent centrality, meaning-making, mechanical restraint episodes, mental healthcare providers, psychological adjustment | INTRODUCTIONMental healthcare providers (care providers) play an integral role in mitigating suffering among psychiatric patients, but are themselves regularly exposed to stressful episodes in their work that challenge their sense of self and well-being (Kelly, Fenwick, Brekke, & Novaco, 2016). The performance of care providers is linked to their psychological adjustment (Needham, Abderhalden, Halfens, Fischer, & Dassen, 2005). If we wish to prevent burnout and ensure highquality care of patients, the adjustment of care providers' needs to be a priority in research (Hunter & Carmel, 1992;Jackson, Clare, & Mannix, 2002). Furthermore, in order to train and supervise care providers, it is essential to understand how stressful encounters with patients affect them. Recent theoretical models suggest that highly stressful events can increase the risk of post-traumatic stress disorder (PTSD) and other mental health problems, if they are interpreted as having had a central influence on self-understanding (Gehrt, Berntsen, Hoyle, & Rubin, 2018). This implies that not only the mere exposure to stressful encounters with patients, but also the interpretation of such episodes is important for psychological adjustment. In the present study, we used mechanical restraint episodes as an outset to study this relationship.While the majority of psychiatric patients are not assaultive, it is well-documented that nurses and other professionals working in
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