Bio-H App

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Arhive autor: madalinasucalapsychologyro

Obiectivele proiectului

Obiectiv 1: Investigarea utilizabilităţii aplicaţiei mobile de relaxare prin auto-hipnoză (H-App). Primul obiectiv al acestei propuneri este dezvoltarea unei aplicaţii smartphone de relaxare prin auto-hipnoză şi investigarea utilizabilităţii acesteia prin utilizarea unui panel de experţi (focus group cu experţi) şi prin testarea validităţii interfeţei cu utilizatorii.  

Obiectiv 2: Investigarea eficienţei clinice a aplicaţiei mobile de relaxare prin auto-hipnoză pentru reducerea anxietăţii şi durerii la pacientele cu CNB. Paciente (N=114) de la Institutul Oncologic “Ion Chiricuţă” (IOCN) vor fi randomizate într-unul din două grupuri: a) grupul H-app (n=57), în care pacientele vor avea acces la o aplicaţie care conţine un scenariu audio de relaxare prin auto-hipnoză (scenariul deja validat în RCT15); b) grupul de control (n=57), în care pacientelor li se va da acces la o aplicaţie care are aceleaşi facilităţi, dar nu conţine scenariul auto-hipnotic. Ipoteza este că vor exista diferenţe semnificative pentru durere şi anxietate între cele două grupuri. Concret, grupul H-app va avea rezultate superioare grupului de control.

Obiectiv 3: Testarea variabilelor mediatoare (expectanţe de răspuns, credinţe disfuncţionale) şi moderatoare (factori demografici şi atitudinali). Modelul va fi testat folosind procedura LGCM (latent growth curve modelling) şi ne va ajuta să înţelegem mecanismele responsabile pentru efectele relaxării prin auto-hipnoză.

Etapa în care se află proiectul

Rapoarte științifice

Colectarea datelor şi analiza lor

Colectarea datelor: Toate chestionarele ce măsoară nivelul de bază vor fi completate într-o locaţie în camera de aşteptare a IOCN, pentru confortul pacientelor.  În medie, completarea chestionarelor va dura 15-20 minute. După baseline, toate participantele vor completa chestionarele în ziua procedurii CNB de 3 ori: înainte de procedură, după aceasta şi la externare. Aceste momente de măsurare au fost ales din trei motive: 1) coincid cu programările pentru CNB; şi 2) respectă recomandările de monitorizare din timpul procedurii.

Demersul analitic:

Obiectivul 1. Panel experţi: Primele versiuni ale  aplicaţiei H-app şi a celei pentru grupul de control vor fi trimise la trei experţi în psihologie clinică şi revizuite conform sugestiilor acestora, generându-se astfel versiunile secundare. Versiunile secundare vor fi prezentate unui panel de 10 experţi multi-disciplinari (psihologi, oncologi, experţi IT) în cadrul unor întâlniri de focus-group. Amendamentele derivate din consensul acestora vor permite generarea versiunii terţiare pentru ambele aplicaţii. Validarea interfeţei: Versiunea 3 va fi testată cu 10 paciente CNB, generând informaţii despre modificările necesare îmbunătăţirii utilizabilităţii. Aceste date vor fi folosite pentru dezvoltarea versiunii 4, care va fi trimisă înapoi la panelul de experţi pentru alte comentarii, generând versiunea finală a intervenţiei.

Obiectivul 2. Vom folosi abordarea MLM (modelării multinivelare) pentru a testa efectele inter-grup de-a lungul timpului. MLM are avantajul oferirii unor estimări mai precise ale efectelor terapeutice.

Obiectivul 3. Modelul mediaţional va fi testat cu ajutorul LGCM (latent growth curve modelling). Factorii demografici, medicali şi atitudinile despre hipnoză vor fi testaţi ca moderatori.

Participanţi şi procedură

N=114.

Studiul este structurat să atingă o putere statistică de minim 80%, la un prag de 0.5, pentru a detecta variaţii medii ale mărimilor efectului. Analiza puterii statistice pentru aceste date a indicat necesitatea unui eşantion de 57 de participante per grup pentru. Bazându-ne pe statisticile IOCN3 (Institutul Oncologic Ion Chiricuţă), atingerea mărimii acestui eşantion este un ţel fezabil. Atât procedura CNB cât şi derularea acestui studiu se vor desfăşura ȋn regim ambulatoriu, prin urmare rata de atriţie a pacientelor va fi redusă (nu sunt necesare deplasări suplimentare la spital). Criteriile de eligibilitate vor include: vârsta peste 18 ani, cunoaşterea limbii române (procedurile şi materialele vor fi explicate şi livrate în limba română), programare pentru procedura CNB şi disponibilitatea de a fi randomizată într-unul dintre cele două grupuri. Criteriile de excludere includ: prezenţa comorbidităţilor psihiatrice care ar putea interfera cu abilitatea pacientelor de a adera la procedură şi de a-şi da consimţământul informat.

Procedura. După obţinerea consimţământului informat, pacientele vor fi distribuite aleator într-unul dintre cele două grupuri (H-app sau grupul de control). Pacientele care deţin un iPhone, iPad sau iTouch vor fi rugate să îşi descarce gratuit aplicaţia H-App sau aplicaţia pentru grupul de control. Ambele aplicaţii includ instrucţiunile proprii de utilizare. Luând în considerare posibila lipsă de familiaritate cu folosirea aplicaţiilor, un asistent de cercetare le va furniza instrucţiuni şi un model de utilizare până ce fiecare pacientă va fi capabilă să o folosească singură. Participantelor care nu deţin un Smartphone, li se va furniza  un iPod Touch. Dispozitivul iPod Touch va fi dezactivat pentru utilizarea oricăror alte aplicaţii pentru a descuraja furtul. Conform studiilor investigate, am găsit că acest demers este unul util. Chestionarele cu privire la rezultatele aşteptate vor fi administrate de un asistent de cercetare la interval stabilite (pre-CNB, post-CNB şi la externare). Design-ul studiului este conform cerinţelor de realizare CONSORT.

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Prezentări în cadrul unor conferinţe

Abstract trimis la 8th Scientific Meeting of the International Society for Research on Internet Interventions (ISRII) – 7-9 Aprilie, Seattle, Washington, USA

Randomized Clinical Trial of a symptom management app for patients undergoing core needle breast biopsy

Background: Breast cancer is one the most common cancers among women. One of the frequently used diagnosis tools for breast cancer is Core Needle Biopsy. Although CNB is a reliable diagnostic tool, it is associated with side effects, such as pain and anxiety. As pharmacological treatments for these side effects are not offered in outpatients settings where CNB is performed, the patients are left with no solutions for their suffering. Previous research shows that there are evidence-based treatments for CNB-related pain and anxiety. However, outpatient CNB settings rarely have the resources to make such evidence-based treatments available for women undergoing breast biopsy. Smartphones provide an unprecedented opportunity to deliver evidence-based interventions while requiring less costs (e.g., facilities and trained personnel), and thus broadening the accessibility of treatment.

Aim: The overall goal of this Randomized Clinical Trial is to investigate the clinical efficacy of a smartphone app-based intervention for CNB-related pain and anxiety.

Methods: 114 women will be randomized to either CNB app-based symptom management (BIO-APP) or treatment as usual (TAU). The primary outcomes will be self-reported anxiety and pain levels (pain intensity and pain unpleasantness). Baseline, pre, post and follow-up information will be collected using electronic diaries and questionnaires included in the app.

Conclusions: The study will provide empirical evidence on the clinical efficacy of an app-based intervention for managing CNB-related pain and anxiety.

Articole publicate in cadrul proiectului

Gherman, A., Achimaş-Cadariu, P., & Sucală, M. (2016). A Systematic Analysis of Mobile Apps that Prepare Patients for Medical Procedure. Journal of Evidence-Based Psychotherapies, 16(1), 85–90.

Articole ale echipei relevante pentru proiect

Credinţe disfuncţionale şi simptome asociate cu cancerul şi tratamentul său.

Sucala, M., Petrisor, C., Achimas-Cadariu, P., & David, D. (2014). Predictors of quality of life during chemotherapy for breast cancer. Investigating the role of multidimensional symptoms and dysfunctional beliefs. Journal of Evidence-Based Psychotherapies.

Sucala, M., Schnur, J., Brackman, E., David, D., & Montgomery, G. (2013). The role of specific and core dysfunctional beliefs in breast cancer radiotherapy patients’ fatigue. Journal of Health Psychology.

Sucala, M., Schnur, J., Greene, P., David, D., Erblich, J., & Montgomery, G. (2013). Cognitive-Emotional Equation: The Relationship between Cognitive Processes, Cognitive Contents and Specific Emotions. Evidence from a Sample of Breast Cancer Patients. Journal of Cognitive and Behavioral Psychotherapies

Expectanţele de răspuns şi simptome asociate tratamentelor oncologice.

Sucala, M., Szentagotai-Tatar, A. (2010). Optimism, pessimism and mood regulation expectancies in cancer patients. Journal of Cognitive and Behavioral Psychotherapies.

Sohl, S., Schnur, J., Sucala, M., David, D., Winkel G., & Montgomery, G. (2011). Distress and emotional well-being in breast cancer patients prior to radiotherapy: an expectancy-based model. Psychology & Health.

Hipnoza pentru managementul simptomelelor.

Montgomery, G.H., David, D., Kangas, M., Green, S., Sucala, et al.  (2014). A Randomized Clinical Trial of a Cognitive-Behavioral Therapy plus Hypnosis Intervention to Control Fatigue in Breast Cancer Radiotherapy Patients. Journal of Clinical Oncology.

Tehnologia mobilă aplicată ȋn sănătate.

Sucala, M., Schnur, J.B., Glazier, K., Miller, S.J., Green, J.P., & Montgomery, G.H. (2013). Hypnosis: There’s an App for that. A systematic review of hypnosis apps. International Journal of Clinical and Experimental Hypnosis.

Sucala, M., Schnur, J., Brackman, E., Constantino, M., & Montgomery, G. (2013). Clinicians’ attitudes towards therapeutic alliance in E-therapy. Journal of General Psychology.

Sucala, M., Schnur, J.B., Constantino, M., Miller, S.J., Brackman, E., Montgomery, G.H. (2012). The Therapeutic Relationship in E-Therapy for Mental Health: A Systematic Review. Journal of Medical Internet Research.

Cristea, I., Sucala, M., & David, D. (2013). Can you tell the difference? Comparing face-to-face versus computer-based interventions. Journal of Cognitive and Behavioral Psychotherapies.

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