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PREPARE: PreoPerative Anxiety REduction. One-Year Feasibility RCT on a Brief Psychological Intervention for Pancreatic Cancer Patients Prior to Major Surgery.

ABSTRACT: Introduction:The aim of the present paper is to establish feasibility and required power of a one-session psychological intervention devoted to increasing patient's self-efficacy and awareness in dealing with anxiety symptoms before major pancreatic cancer surgery. Methods:Parallel assignment RCT. All consenting patients listed for pancreatic major surgery during day-hospital visits (T0) between June 2017-June 2018 were assigned randomly in blocks of ten to a psychological intervention vs usual care group to be held the day before surgery (T1). The psychological intervention provided the patient the opportunity to increase self-efficacy in dealing with anxiety by talking with a psychologist about personal concerns and learning mindfulness based techniques to cope with anxiety. Results:400 patients were randomized into the experimental vs. usual care group. 49 and 65, respectively, completed baseline and post-intervention measures. The dropout rate between day-hospital (T0) and pre-surgery intervention (T1) was high (74.5%) due to several management and organization pitfalls. The main outcome, perceived self-efficacy in managing anxiety, showed a significant increase in the intervention group compared to the control group (p < 0.001), and was related to a reduction in state anxiety (p < 0.001). The intervention group perceived also lower emotional pain (p = 0.03). A power analysis was performed to define the appropriate sample size in a definitive RCT. Conclusion:Beneath the complexity in retaining patients along their trajectory in pancreatic surgery department, when they had the opportunity to follow a brief psychological intervention, most of them adhered, showing a significant reduction in preoperative emotional distress and less emotional pain perception after surgery. Even if results need caution because of the high attrition rate, we can infer that our psychological intervention has the potential to be proposed in surgical setting, being short, easy to learn and applicable to a wide range of patients. Clinical Trial Registration:The trial was registered on ClinicalTrials.gov (identifier: NCT03408002). The full protocol is available from the last author.

SUBMITTER: Marinelli V

PROVIDER: S-EPMC7066303 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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PREPARE: PreoPerative Anxiety REduction. One-Year Feasibility RCT on a Brief Psychological Intervention for Pancreatic Cancer Patients Prior to Major Surgery.

Marinelli Veronica V Danzi Olivia Purnima OP Mazzi Maria Angela MA Secchettin Erica E Tuveri Massimiliano M Bonamini Deborah D Rimondini Michela M Salvia Roberto R Bassi Claudio C Del Piccolo Lidia L

Frontiers in psychology 20200305

<h4>Introduction</h4>The aim of the present paper is to establish feasibility and required power of a one-session psychological intervention devoted to increasing patient's self-efficacy and awareness in dealing with anxiety symptoms before major pancreatic cancer surgery.<h4>Methods</h4>Parallel assignment RCT. All consenting patients listed for pancreatic major surgery during day-hospital visits (T0) between June 2017-June 2018 were assigned randomly in blocks of ten to a psychological interve ...[more]

PMID: 32194490

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Project description:Up to 50% of patients undergoing hemodialysis suffer from symptoms of depression and/or anxiety. Access to traditional pharmacotherapies and psychotherapies for depression or anxiety in this patient population has been inadequate. The objective of this study was to investigate the feasibility and effectiveness of brief mindfulness meditation intervention for patients on hemodialysis with depression and anxiety symptoms.This study was a randomized, controlled, assessor-blinded trial conducted in an urban hemodialysis unit. Forty-one patients were randomly assigned to intervention (n=21) and treatment-as-usual (n=20) groups. The intervention group received an 8-week individual chairside meditation intervention lasting 10-15 minutes, three times a week during hemodialysis. Feasibility outcomes were primarily assessed: enrollment rates, intervention completion rates, and intervention tolerability. Symptoms of depression and anxiety were measured using the Patient Health Questionnaire (PHQ-9) and the General Anxiety Disorder-7 (GAD-7).Of those deemed eligible for the study, 67% enrolled (41 of 61). Of the participants randomized to the intervention group, 71% completed the study, with meditation being well tolerated (median rating of 8 of 10 in a Likert scale; interquartile range=10-5 of 10). Barriers to intervention delivery included frequent hemodialysis shift changes, interruptions by staff or alarms, space constraints, fluctuating participant medical status, and participant fatigue. Meditation was associated with subjective benefits but no statistically significant effect on depression scores (change in PHQ-9, -3.0±3.9 in the intervention group versus -2.0±4.7 in controls; P=0.45) or anxiety scores (change in GAD-7, -0.9±4.6 versus -0.8±4.8; P=0.91).On the basis of the results of this study, mindfulness meditation appears to be feasible and well tolerated in patients on hemodialysis with anxiety and depression symptoms. The study did not reveal significant effects of the interventions on depression and anxiety scores.This article contains a podcast at https://www.asn-online.org/media/podcast/CJASN/2017_10_12_CJASNPodcast_17_12_.mp3.

Project description:BackgroundPsychiatric inpatients often have limited access to psychotherapeutic education or skills for managing anxiety, a common transdiagnostic concern in severe and acute mental illness. COVID-19-related restrictions further limited access to therapy groups on inpatient psychiatric units. App-based interventions may improve access, but evidence supporting the feasibility of their use, acceptability, and effectiveness in psychiatric inpatient settings is limited. MindShift CBT is a free app based on cognitive behavioral therapy principles with evidence for alleviating anxiety symptoms in the outpatient setting.ObjectiveWe aimed to recruit 24 participants from an acute general psychiatric inpatient ward to a 1-month randomized control study assessing the feasibility and acceptability of providing patients with severe and acute mental illness access to the MindShift CBT app for help with managing anxiety symptoms.MethodsRecruitment, data collection, analysis, and interpretation were completed collaboratively by clinician and peer researchers. Inpatients were randomized to two conditions: treatment as usual (TAU) versus TAU plus use of the MindShift CBT app over 6 days. We collected demographic and quantitative data on acceptability and usability of the intervention. Symptoms of depression, anxiety, and psychological distress were measured in pre- and poststudy surveys for preliminary signals of efficacy. We conducted individual semistructured interviews with participants in the MindShift CBT app group at the end of their trial period, which were interpreted using a standardized protocol for thematic analysis.ResultsOver 4 weeks, 33 inpatients were referred to the study, 24 consented to participate, 20 were randomized, and 11 completed the study. Of the 9 randomized participants who did not complete the study, 7 were withdrawn because they were discharged or transferred prior to study completion, with a similar distribution among both conditions. Among the enrolled patients, 65% (13/20) were admitted for a psychotic disorder and no patient was admitted primarily for an anxiety disorder. The average length of stay was 20 days (SD 4.4; range 3-21) and 35% (7/20) of patients were involuntarily admitted to hospital. Small sample sizes limited accurate interpretation of the efficacy data. Themes emerging from qualitative interviews included acceptability and usability of the app, and patient agency associated with voluntary participation in research while admitted to hospital.ConclusionsOur study benefitted from collaboration between peer and clinician researchers. Due to rapid patient turnover in the acute inpatient setting, additional flexibility in recruitment and enrollment is needed to determine the efficacy of using app-based psychotherapy on an acute psychiatric ward. Despite the limited sample size, our study suggests that similar interventions may be feasible and acceptable for acutely unwell inpatients. Further study is needed to compare the efficacy of psychotherapeutic apps with existing standards of care in this setting.Trial registrationClinicalTrials.gov NCT04841603; https://clinicaltrials.gov/ct2/show/NCT04841603.

Project description:ObjectivesIn routine psychiatric care in Stockholm, Sweden, a comprehensive therapist-guided intervention for clinically significant health anxiety is implemented. However, there is a need for more easily accessible self-care interventions to improve treatment dissemination. This study aimed to transform an existing therapist-guided digital intervention into a self-care intervention, reducing patient burden and used clinical resources while maintaining quality and safety.DesignAn uncontrolled feasibility study.SettingConducted at Karolinska Institutet, a medical university in Sweden, with nationwide recruitment trough online advertisements.ParticipantsTwenty-five adults used the self-care intervention and underwent telephone assessments, along with completing self-rated questionnaires.InterventionThe newly developed 8-week self-care intervention was designed to be user-friendly without therapist guidance, and to facilitate high levels of behavioural engagement.Primary and secondary outcome measuresIndicators of quality and safety, including changes in health anxiety severity (primary), clinician time, participant adherence, perceived credibility/satisfaction with the intervention and adverse events, were benchmarked against a previous study of the more comprehensive intervention it was based on.ResultsCompared with the original guided intervention, the self-care intervention was condensed in terms of text (up to 70% less reading), duration (8 weeks instead of 12) and number of exercises. Quality indicators were similar to the original version. Most participants worked actively with core components in the self-care intervention. Within-group effects on health anxiety from pretreatment to the 3-month follow-up were large (g=1.37; 95% CI 0.74 to 2.00). No serious adverse events were reported.ConclusionsThis brief digital self-care intervention shows potential for increasing access to treatment for individuals with health anxiety while reducing the burden on patients and clinical resources. Future studies should investigate the optimal type of intervention and support for different individuals, and if non-inferiority can be established.Trial registration numberNCT05446766.

Dataset Information

PREPARE: PreoPerative Anxiety REduction. One-Year Feasibility RCT on a Brief Psychological Intervention for Pancreatic Cancer Patients Prior to Major Surgery.

Publications

PREPARE: PreoPerative Anxiety REduction. One-Year Feasibility RCT on a Brief Psychological Intervention for Pancreatic Cancer Patients Prior to Major Surgery.

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