Mobile App-Based Intervention for Adolescents With First-Episode Psychosis: Study Protocol for a Pilot Randomized Controlled Trial

Sara Barbeito, Teresa Sánchez-Gutiérrez, María Mayoral, Miguel Moreno, Sergio Ríos-Aguilar, Celso Arango, Ana Calvo, Sara Barbeito, Teresa Sánchez-Gutiérrez, María Mayoral, Miguel Moreno, Sergio Ríos-Aguilar, Celso Arango, Ana Calvo

Abstract

Introduction: Previous studies have shown an improvement in the access to treatment for patients with first-episode psychosis (FEP), specifically young patients, through mobile app-based interventions. The aim of this study is to test the effectiveness of a mobile app-based intervention to improve community functioning in adolescents with FEP. Mobile app-based interventions could increase quality of life and disease awareness, which improve adherence to treatment and reduce the frequency of relapses and rehospitalizations in adolescents with FEP. Methods: This article describes a mobile app treatment and the pilot trial protocol for patients with FEP. We will perform a single-blind randomized clinical trial (RCT) including patients with FEP aged 14-19 years recruited from Gregorio Marañón Hospital, Madrid, Spain. Patients will be randomly assigned to an intervention group, which will receive treatment as usual plus five modules of a psychological intervention through the mobile app (psychoeducation, recognition of symptoms and prevention of relapses, problem solving, mindfulness, and contact wall), or to a control group (standard care). The effectiveness of the intervention will be assessed by means of an extensive battery of clinical tests at baseline and at 3 months of follow-up. The primary outcome is reduction in psychotic and depressive symptoms; secondary outcomes comprise adherence, awareness, use of drugs, and quality of life. Data will be analyzed on an intention-to-treat (ITT) basis. Mixed model repeated-measures analysis will be used to explore the following effect: group × time interaction between the control group and the intervention group for clinical and functional variables during the follow-up period. Discussion: This is an innovative study for the assessment of a psychological intervention through a mobile app for patients with FEP during the critical period. This pilot RCT is intended to be a precursor to larger studies, which in turn could facilitate dissemination of mobile app therapy for patients with FEP. Ethics and Dissemination: The local ethics committee approved the study protocol. All participants must sign the informed consent, to participate. After finalizing the study, the results will be published. Trial registration: NCT03161249. NCT clinicaltrials.gov. Date of registration in primary registry 02 May 2017. clinicaltrials.gov.

Keywords: adolescents; early onset psychosis; mobile treatment; online treatment; psychotherapy.

Figures

Figure 1
Figure 1
Participant flow diagram.

References

    1. Díaz-Caneja CM, Pina-Camacho L, Rodríguez-Quiroga A, Fraguas D, Parellada M, Arango C. Predictors of outcome in early-onset psychosis: a systematic review. NPJ Schizophr. (2015) 4:14005 10.1038/npjschz.2014.5
    1. Ballageer T, Malla A, Manchanda R, Takhar J, Haricharan R. Is adolescent-onset first-episode psychosis different from adult onset? J Am Acad Child Adolesc Psychiatry (2005) 44:782–9. 10.1097/01.chi.0000164591.55942.ea
    1. Sadock BJ, Sadock VA. Kaplan and Sadock Synopsis of Psychiatry. Madrid: Waverly Hispanica SA; (2004).
    1. Robinson DG, Woerner MG, Alvir JM, Geisler S, Koreen A, Sheitman B, et al. Predictors of treatment response from a first episode of schizophrenia or schizoaffective disorder. Am J Psychiatry (1999)156:544–9.
    1. Penn DL, Waldheter EJ, Perkins DO, Mueser KT, Lieberman JA. Psychosocial treatment for first-episode psychosis: a research update. Am J Psychiatry (2005)162:2220–32. 10.1176/appi.ajp.162.12.2220
    1. Gleeson JF, Cotton SM, Alvarez-Jimenez M, Wade D, Gee D, Crisp K, et al. . A randomized controlled trial of relapse prevention therapy for first-episode psychosis patients: outcome at 30-month follow-up. Schizophr Bull. (2013) 39:436–48. 10.1093/schbul/sbr165
    1. Amminger GP, Henry LP, Harrigan SM, Harris MG, Alvarez-Jimenez M, Herrman H, et al. . Outcome in early-onset schizophrenia revisited: findings from the Early Psychosis Prevention and Intervention Centre long-term follow-up study. Schizophr Res. (2011)131:112–9. 10.1016/j.schres.2011.06.009
    1. Calvo A, Moreno M, Ruiz-Sancho A, Rapado-Castro M, Moreno C, Sánchez-Gutiérrez T, et al. . Intervention for adolescents with early-onset psychosis and their families: a randomized controlled trial. J Am Acad Child Adolesc Psychiatry (2014) 53:688–96. 10.1016/j.jaac.2014.04.004
    1. Bertelsen M, Jeppesen P, Petersen L, Thorup A, Øhlenschlaeger J, le Quach P, et al. . Five-year follow-up of a randomized multicenter trial of intensive early intervention vs standard treatment for patients with a first episode of psychotic illness: the OPUS trial. Arch Gen Psychiatry (2008) 65:762–71. 10.1001/archpsyc.65.7.762
    1. Gafoor R, Nitsch D, McCrone P, Craig TK, Garety PA, Power P, et al. . Effect of early intervention on 5-year outcome in non-affective psychosis. Br J Psychiatry (2010) 196:372–6. 10.1192/bjp.bp.109.066050
    1. Secher RG, Hjorthoj CR, Austin SF, Thorup A4, Jeppesen P5, Mors O, et al. . Ten-year follow-up of the OPUS specialized early intervention trial for patients with a first episode of psychosis. Schizophr Bull. (2015) 41:617–26. 10.1093/schbul/sbu155
    1. Calvo A, Moreno M, Ruiz-Sancho A, Rapado-Castro M, Moreno C, Sánchez-Gutiérrez T, et al. . Psychoeducational group intervention for adolescents with psychosis and their families: a two-year follow-up. J Am Acad Child Adolesc Psychiatry (2015)54:984–90. 10.1016/j.jaac.2015.09.018
    1. Mohr DC, Burns MN, Schueller SM, Clarke G, Klinkman M. Behavioral intervention technologies: evidence review and recommendations for future research in mental health. Gen Hosp Psychiatry (2013) 35:332–8. 10.1016/j.genhosppsych.2013.03.008
    1. Brunette M, Rotondi A, Ben-Zeev D, Gottlieb JD, Mueser KT, Robinson DG, et al. . Coordinated technology-delivered treatment to prevent rehospitalization in schizophrenia: a novel model of care. Psychiatr Serv. (2016) 67:444–7. 10.1176/appi.ps.201500257
    1. Rainie L, Wellman B. Networked: The New Social Operating System. Cambridge, MA: MIT Press; (2012). 10.7551/mitpress/8358.001.0001
    1. Abdel-Baki A, Lal S, D-Charron O, Stip E, Kara N. Understanding access and use of technology among youth with first-episode psychosis to inform the development of technology-enabled therapeutic interventions. Early Interv Psychiatry (2017)11:72–6. 10.1111/eip.12250
    1. Lal S, Dell'Elce J, Malla AK. Technology access and use among young adults with a first episode of psychosis. Psychiatr Serv. (2015) 66:764–5. 10.1176/appi.ps.201400580
    1. Birnbaum AF, Rizvi AF, Correll CU, Kane JM. Role of social media and the Internet in pathways to care for adolescents and young adults with psychotic disorders and non-psychotic mood disorders. Early Interv Psychiatry (2015) 11:290–5. 10.1111/eip.12237
    1. Ben-Zeev D, Brenner C, Begale M, Duffecy J, Mohr D, Mueser K. Feasibility, acceptability, and preliminary efficacy of a smartphone intervention for schizophrenia. Schizophr Bull. (2014) 40:1244–53. 10.1093/schbul/sbu033
    1. Alvarez-Jimenez M, Bendall S, Lederman R, Wadley G, Chinnery G, Vargas S, et al. . On the HORYZON: moderated online social therapy for long-term recovery in first episode psychosis. Schizophr Res. (2013) 143:143–9. 10.1016/j.schres.2012.10.009
    1. Alvarez-Jimenez M, Alcazar-Corcoles MA, González-Blanch C, Bendall S, McGorry PD, Gleeson JF. Online, social media and mobile technologies for psychosis treatment: a systematic review on novel user-led interventions. Schizophr Res. (2014) 156:96–106. 10.1016/j.schres.2014.03.021
    1. Biagianti B, Schlosser D, Nahu M, Woolley J, Vinogradov S. Creating Live Interactions to Mitigate Barriers (CLIMB). A mobile intervention to improve social functioning in people with chronic psychotic disorders. JMIR Ment Health (2016)13:e52 10.2196/mental.6671
    1. Gleeson JF, Lederman R, Wadley G, Bendall S, McGorry PD, Alvarez-Jimenez M. Safety and privacy outcomes from a moderated online social therapy for young people with first episode psychosis. Psychiatr Serv. (2014) 65:46–50. 10.1176/appi.ps.201300078
    1. Husain N, Gire N, Kelly J, Duxbury J, McKeown M, Riley M, et al. . TechCare: mobile assessment and therapy for psychosis - an intervention for clients in the Early Intervention Service: a feasibility study protocol. SAGE Open Med. (2016) 4:2050312116669613. 10.1177/2050312116669613
    1. American Psychiatric Association (APA) Diagnostic and Statistical Manual of Mental Disorders. 5th ed Washington, DC: APA; (2013).
    1. Lambert M, Schöttle D, Ruppelt F, Rohenkohl A, Sengutta M, Luedecke D, et al. . Early detection and integrated care for adolescents and young adults with psychotic disorders: the ACCESS III study. Acta Psychiatr Scand. (2017)136:188–200 10.1111/acps.12762
    1. Lambert M, Karow A, Leucht S, Schimmelmann BG, Naber D. Remission in schizophrenia: validity, frequency, predictors, and patients' perspective 5 years later. Dialogues Clin Neurosci. (2010)12:393–407.
    1. Rund BR, Moe L, Sollien T, Fjell A, Borchgrevink T, Hallert M, et al. . The psychosis project: outcome and cost effectiveness of a psychoeducational treatment programme for schizophrenic adolescents. Acta psychiatry Scand. (1994) 89:211–8.
    1. Enderami A, Monesi FS, Zarghami M. One-year follow-up of patients with a diagnosis of first episode psychosis. Mater Sociomed. (2017) 29:21–5. 10.5455/msm.2017.29.21-25
    1. Ohmuro N, Matsumoto K, Ishii Y, Katsura M, Obara C, Kikuchi T, et al. . The associations between quality of life and clinical symptoms in individuals with an at-risk mental state and first-episode psychosis. Psychiatry Res. (2017)254:54–9. 10.1016/j.psychres.2017.04.031
    1. Lutgens D, Iyer S, Joober R, Brown TG, Norman R, Latimer E, et al. . A five-year randomized parallel and blinded clinical trial of an extended specialized early intervention vs. regular care in the early phase of psychotic disorders: study protocol. BMC Psychiatry (2015) 15:22. 10.1186/s12888-015-0404-2
    1. Kay SR, Fiszbein A, Opler LA. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull. (1987) 13:261. 10.1093/schbul/13.2.261
    1. Peralta V, Cuesta M. Validación de la escala de los síndromes positivo y negativo (PANNS) en una muestra de esquizofrénicos españoles. Actas Luso Esp Neurol Psiquiatr. (1994) 22:171–7.
    1. Andreasen N. The Scale for the Assessment of Positive Symptoms (SAPS). Iowa city, IA: University of Iowa; (1984).
    1. Andreasen N. The Scale for the Assessment of Negative Symptoms (SANS). Iowa city, IA: University of Iowa; (1983).
    1. Vazquez C. Traducción Española de la escala para la valoración de síntomas negativos (SANS). Facultad Psicol. (1989).
    1. Vazquez C. Traducción Española de la escala para la valoración de síntomas positivos (SAPS). Facultad de Psicol. (1989).
    1. Spielberger CD, Gorsuch RL, Lushene R, Vagg PR, Jacobs GA. Manual for the State-Trait Anxiety Inventory. Palo Alto, CA: Consulting Psychologists Press; (1983).
    1. Bermúdez J. Anxiety and performance. Rev Psicol Gen Apl. (1978) 151:183–207.
    1. Guillén- Riquelme A, Buela-Casal G. psicométrica y funcionamiento diferencial de los ítems en el State Trait Anxiety Inventory (STAI). Psicothema (2011) 23:510–5.
    1. Hamilton M. A rating scale for depression. J Neurol Neurosurg Psychiatry (1960) 23:56–62. 10.1136/jnnp.23.1.56
    1. Ramos-Brieva JA, Cordero A. Validación de la versión castellana de la escala Hamilton para la depresión. Actas Luso Esp Neurol Psiquiatr. (1986) 14:335–8.
    1. Amador XF, Strauss DH, Yale SA, Flaum MM, Endicott J, Gorman JM. Assessment of insight in psychosis. Am J Psychiatry (1993) 150:873–9. 10.1176/ajp.150.6.873
    1. Ruiz A, Pousa E, Duñó R, Crosas J, Cuppa S, García C. Spanish adaptation of the Scale to Assess Unawareness of Mental Disorder (SUMD). Actas Esp Psiquiatr. (2008) 36:111–1198.
    1. Strauss SJ, Carpenter WT., Jr The prediction of outcome in schizophrenia: part I. Characteristics of outcome. Arch Gen Psychiatry (1972) 27:739–46. 10.1001/archpsyc.1972.01750300011002
    1. Strauss SJ, Carpenter WT, Jr. The prediction of outcome in schizophrenia. II. Relationships between predictor and outcome variables: a report from the WHO pilot international pilot study of schizophrenia. Arch Gen Psychiatry (1974) 31:37–42.
    1. Strauss SJ, Carpenter WT, Jr. Characteristic symptoms and outcome in schizophrenia. Arch Gen Psychiatry (1974) 30:429–42.
    1. Ahuir M, Bernardo M, de la Serna E, Ochoa S, Carlson J, Escartín G, et al. . Adaptation and validation of the Spanish version of the Strauss and Carpenter Prognostic Scale for Schizophrenia. Rev Psiquiatr Salud Ment. (2009) 2:150–9. 10.1016/S1888-9891(09)73233-1
    1. American Psychiatric Association (APA) Diagnostic and Statistical Manual of Mental Disorders. 4th ed Washington, DC: American Psychiatric Press; (2000).
    1. Jones SH, Thornicroft G, Coffey M, Dunn G. A brief mental health outcome scale-reliability and validity of the Global Assessment of Functioning (GAF). Br J Psychiatry (1995) 166:654–9. 10.1192/bjp.166.5.654
    1. Shaffer D, Gould MS, Brasic J, Ambrosini P, Fisher P, Bird H, et al. . A Children's Global Assessment Scale (CGAS). Arch Gen Psychiatry (1983) 40:1228–31.
    1. Ezpeleta L, Granero R, de la Osa N. Evaluación del deterioro en niños y adolescentes a través de la Children's Global Assessment Scale (CGAS). Revista de Psiquiatría Infanto-Juvenil (1999) 1:18–26.
    1. Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care (1986) 24:67–74. 10.1097/00005650-198601000-00007
    1. Val A, Amorós G, Martínez P, Fernández ML, León M. Descriptive study of patient compliance in pharmacologic antihypertensive treatment and validation of the Morisky and Green test. Atención Primaria Sociedad Española Med Familia Comun. (1992) 10:767–70.
    1. McLellan AT, Kushner H, Metzger D, Peters R, Grissom G, Pettinati H, et al. The fifth edition of the addition severity index. J Subst Abuse Treat. (1992) 9:199–213.
    1. Guerra D. El índice de severidad de la adicción. In: Bueno S, Torrecilla JM, editors. Medicina Legal en Drogodependencias. Madrid: Harcourt; Agencia antidroga de la Comunidad de Madrid; (1992). p. 186–207.
    1. WHOQOL GROUP. Study Protocol for the World Health Organization Project to develop a Quality of Life Assessment Instrument (WHOQOL). Qual Life Res. (1993) 2:153–9. 10.1007/BF00435734
    1. Lucas-Carrasco R. The WHO quality of life (WHOQOL) questionnaire: Spanish development and validation studies. Qual Life Res. (2012) 21:161–5. 10.1007/s11136-011-9926-3
    1. EuroQol Group. EuroQol — a new facility for the measurement of health-related quality of life. Health Policy (1990) 16:199–208. 10.1016/0168-8510(90)90421-9
    1. Badia X, Roset M, Montserrat S, Herdman M, Segura A. The Spanish version of EuroQol: a description and its applications. European Quality of Life scale. Med Clin. (1999)112(Suppl.):79–85.
    1. McFarlane WR, Deakins SM, Gingerich SL, Dunne E, Horen B, Newmark M. Multiple-Family Psychoeducational Group treatment Manual. New York, NY: New York State Psychiatric Institute; (1991).
    1. McFarlane WR, Dushay RA, Stastny P, Deakins SM, Link B. A comparison of two levels of family-aided assertive community treatment. Psychiatr Serv. (1996) 47:744–50. 10.1176/ps.47.7.744
    1. McFarlane WR, Cook WL, Downing D, Ruff A, Lynch S, Adelsheim S, et al. Early detection, intervention, and prevention of psychosis program: rationale, design, and sample description. Adolesc Psychiatry (2012) 2:112–24. 10.2174/2210676611202020112
    1. Ruiz- Sancho A, Calvo A, Rapado-Castro M, et al. PIENSA development of an early intervention program for adolescent with early onset psychosis and their families. Adolesc Psychiatry (2012) 2:229–36. 10.2174/2210676611202030229
    1. Louise S, Fitzpatrick M, Strauss C, Rossell SL, Thomas N. Mindfulness and acceptance-based interventions for psychosis: our current understanding and a meta-analysis. Schizophr Res. (2017) 192:57–63. 10.1016/j.schres.2017.05.023
    1. Mistler LA, Ben-Zeev D, Carpenter-Song E, Brunette MF, Friedman MJ. Mobile Mindfulness intervention on an acute psychiatric unit: feasibility and acceptability study. JMIR Ment Health (2017) 4:e34. 10.2196/mental.7717
    1. Highton-Williamson E, Priebe S, Giacco D. Online social networking in people with psychosis: a systematic review. Int J Soc Psychiatry (2015) 61:92–101. 10.1177/0020764014556392
    1. Schafer JL, Graham JW. Missing data: our view of the state of the art. Psychol Methods (2002) 7:147–77. 10.1037/1082-989X.7.2.147
    1. Cohen J. Ed. Statistical Power Analysis for the Behavioral Sciences. New York, NY, Academic Press; (1988).
    1. Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, et al. . CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. J Clin Epidemiol. (2010) 63:e1–37. 59. 10.1136/bmj.c869
    1. Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Ann Intern Med. (2010) 152:726–32. 10.7326/0003-4819-152-11-201006010-00232
    1. Chan A-W, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, KrleŽa-Jerić K, et al. . SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. (2013) 158:200–7. 10.7326/0003-4819-158-3-201302050-00583
    1. Chan A-W, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, et al. . SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. Br Med J. (2013) 346:e7586. 10.1136/bmj.e7586
    1. Andrade LH, Alonso J, Mneimneh Z, Wells JE, Al-Hamzawi A, Borges G, et al. . Barriers to mental health treatment: results from the WHO World Mental Health surveys. Psychol Med. (2014) 44:1303–17. 10.1017/S0033291713001943
    1. Christensen H, Hickie I. E-mental health: a new era in delivery of mental health services. Med J Aust. (2010) 192(11 Suppl.):S2–3.
    1. McGorry PD1, Killackey EJ. Early intervention in psychosis: a new evidence based paradigm. Epidemiol Psichiatr Soc. (2002) 11:237–47. 10.1017/S1121189X00005807
    1. Rice S, Gleeson J, Davey C, Hetrick S, Parker A, Lederman R, et al. . Moderated online social therapy for depression relapse prevention in young people: pilot study of a 'next generation' online intervention. Early Interv Psychiatry (2016) 12:613–25. 10.1111/eip.12354
    1. Ramsey AT, Baumann A, Patterson Silver Wolf D, Yan Y, Cooper B, Proctor E. The need for data-informed clinical supervision in substance use disorder treatment. J Addict Dis. (2017) 36:117–26. 10.1080/10550887.2017.1291051
    1. Petersen L, Jeppesen P, Thorup A, Abel MB, Øhlenschlaeger J, Christensen TØ, et al. . A randomised multicentre trial of integrated versus standard treatment for patients with a first episode of psychotic illness. BMJ (2005) 331:602. 10.1136/bmj.38565.415000.E01
    1. Khoury B1, Lecomte T, Gaudiano BA, Paquin K. Mindfulness interventions for psychosis: a meta-analysis. Schizophr Res. (2013) 150:176–84. 10.1016/j.schres.2013.07.055
    1. Moritz S, Cludius B, Hottenrott B, Schneider BC, Saathoff K, Kuelz AK, Gallinat J. Mindfulness and relaxation treatment reduce depressive symptoms in individuals with psychosis. Eur Psychiatry (2015) 30:709–14. 10.1016/j.eurpsy.2015.05.002
    1. Lecardeur L. Cognitive behavior therapy after first-episodes psychosis. Encephale (2013) 39:S115–20. 10.1016/S0013-7006(13)70106-4
    1. Stafford MR, Jackson H, Mayo-Wilson E, Morrison AP, Kendall T. Early interventions to prevent psychosis: systematic review and meta-analysis. BMJ (2013) 346:f762. 10.1136/bmj.f185
    1. Schlosser DA, Campellone TR, Truong B, Etter K, Vergani S, Komaiko K, et al. . Efficacy of PRIME, a mobile app intervention designed to improve motivation in young people with schizophrenia. Schiz Bull. (2018) 44:1010–20. 10.1093/schbul/sby078
    1. Depp CA, Kim DH, Vergel de Dios L, Wang V, Ceglowski J. A pilot study of mood ratings captured by mobile phone versus paper-and-pencil mood charts in bipolar disorder. J Dual Diagn. (2012) 8:326–32. 10.1080/15504263.2012.723318
    1. Depp CA, Moore RC, Perivoliotis D, Granholm E. Technology to assess and support self-management in serious mental illness. Dialogues Clin Neurosci. (2016) 18:171–83.
    1. Grist R, Porter J, Stallard P. Mental health mobile apps for preadolescents and adolescents: a systematic review. J Med Internet Res. (2017) 19:e176 10.2196/jmir.7332

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