Improving Depressive Symptoms through Personalised Exercise and Activation (IDEA): Study Protocol for a Randomised Controlled Trial

Aitana García-Estela, Natalia Angarita-Osorio, Sandra Alonso, Maria Polo, Maria Roldán-Berengué, Monique Messaggi-Sartor, Estanislao Mur-Mila, Laura Vargas-Puertolas, Víctor Pérez, Esther Duarte, Francesc Colom, Aitana García-Estela, Natalia Angarita-Osorio, Sandra Alonso, Maria Polo, Maria Roldán-Berengué, Monique Messaggi-Sartor, Estanislao Mur-Mila, Laura Vargas-Puertolas, Víctor Pérez, Esther Duarte, Francesc Colom

Abstract

Individuals who suffer from depressive symptoms experience a substantial impact on psychosocial functioning, physical health, mortality, and quality of life. In the search for therapeutic strategies, exercise has been found to play a relevant part in its treatment. However, the promotion of exercise entails adherence difficulties that arose out of the tendency towards sedentarism led by symptomatology. Personalised exercise plans on top of usual care have the potential to enhance behavioural changes and mental health. The present study aims at evaluating the changes in functioning deriving from a blended intervention merging a psychological intervention with a personalised exercise programme based on medical assessment. We will conduct a three-arm randomised controlled trial in which 172 participants suffering from mild-moderate depressive symptoms will be allocated to Intervention A (personalised exercise group programme + app with motivational messages), B (personalised exercise group programme + app with no motivational messages) or control group (app with no motivational messages). Data regarding global functioning, well-being, symptoms, physical activity, and exercise capacity will be collected at baseline, 4, 12, and 36 weeks. The results of this trial will provide information about whether this physical activity support programme may be efficient for improving mental and physical health outcomes. Trial registration: ClinicalTrials.gov NCT04857944 (accessed on 15 April 2021). Registered April 2021.

Keywords: blended intervention; depressive symptoms; exercise; personalised medicine; transdisciplinary.

Conflict of interest statement

The authors declare no conflict of interest. The funders had no role in the design of the study; in the writing of the manuscript, or in the decision to publish the protocol.

Figures

Figure 1
Figure 1
Flowchart of the IDEA Project. IDEA: Improving Depression through Exercise and Activity; RCT: randomised controlled trial; TAU = treatment as usual; T1 = 4-week assessment; T2 = 12-week assessment; T3 = 36-week final assessment.
Figure 2
Figure 2
Screenshots of IDEApp running on a smartphone (messages in Catalan). (A)—login and register screen; (B)—home Screen without notification; (C)—home screen with motivational notification.

References

    1. Global Burden of Disease Study 2017 Collaborators Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990–2017: A systematic analysis for the global burden of disease study 2017. Lancet. 2018;392:1789–1858. doi: 10.1016/S0140-6736(18)32279-7.
    1. World Health Organization Depression and Other Common Mental Disorders: Global Health Estimates. [(accessed on 26 January 2021)]; Available online: .
    1. Thornicroft G., Chatterji S., Evans-Lacko S., Gruber M., Sampson N., Aguilar-Gaxiola S., Al-Hamzawi A., Alonso J., Andrade L., Borges G., et al. Undertreatment of people with major depressive disorder in 21 countries. Br. J. Psychiatry. 2017;210:119–124. doi: 10.1192/bjp.bp.116.188078.
    1. Norton P.J. An open trial of a transdiagnostic cognitive-behavioral group therapy for anxiety disorder. Behav. Ther. 2008;39:242–250. doi: 10.1016/j.beth.2007.08.002.
    1. Schmidt N.B., Buckner J.D., Pusser A., Woolaway-Bickel K., Preston J.L., Norr A. Randomized controlled trial of false safety behavior elimination therapy: A unified cognitive behavioral treatment for anxiety psychopathology. Behav. Ther. 2012;43:518–532. doi: 10.1016/j.beth.2012.02.004.
    1. Rosenbaum S., Tiedemann A., Sherrington C., Curtis J., Ward P.B. Physical activity interventions for people with mental illness: A systematic review and meta-analysis. J. Clin. Psychiatry. 2014;75:964–974. doi: 10.4088/JCP.13r08765.
    1. Cuijpers P., van Straten A., Andersson G., van Oppen P. Psychotherapy for depression in adults: A meta-analysis of comparative outcome studies. J. Consult. Clin. Psychol. 2008;76:909–922. doi: 10.1037/a0013075.
    1. Schuch F., Vancampfort D., Firth J., Rosenbaum S., Ward P., Reichert T., Bagatini N.C., Bgeginski R., Stubbs B. Physical activity and sedentary behavior in people with major depressive disorder: A systematic review and meta-analysis. J. Affect. Disord. 2017;210:139–150. doi: 10.1016/j.jad.2016.10.050.
    1. Stanczykiewicz B., Banik A., Knoll N., Keller J., Hohl D.H., Rosińczuk J., Luszczynska A. Sedentary behaviors and anxiety among children, adolescents and adults: A systematic review and meta-analysis. BMC Public Health. 2019;19:459. doi: 10.1186/s12889-019-6715-3.
    1. Pelletier L., Shanmugasegaram S., Patten S.B., Demers A. Self-management of mood and/or anxiety disorders through physical activity/exercise. Health Promot. Chronic Dis. Prev. Canada Res. Policy Pract. 2017;37:149–159. doi: 10.24095/hpcdp.37.5.03.
    1. National Collaborating Centre for Mental Health(UK) The NICE Guideline on the Treatment and Management of Depression in Adults (Updated Edition) British Psychological Society; Leicester, UK: 2010.
    1. Barcelona City Council Technical Programming Cabinet. Barcelona Economics (2018). Territorial Distribution of Available Family Income Per Capita (2017) [(accessed on 26 January 2021)]; Available online: .
    1. Ware J.E., Snow K.K., Kosinski M., Gandek B. SF-36 Health Survey. Manual and Interpretation Guide. The Health Institute, New England Medical Center; Boston, MA, USA: 1993.
    1. Vilagut G., Ferrer M., Rajmil L., Rebollo P., Permanyer-Miralda G., Quintana J.M., Alonso J. El Cuestionario de Salud SF-36 español: Una década de experiencia y nuevos desarrollos. Gac. Sanit. 2005;19:135–150. doi: 10.1157/13074369.
    1. Kroenke K., Spitzer R.L., Williams J.B. The PHQ-9: Validity of a brief depression severity measure. J. Gen. Intern. Med. 2001;16:606–613. doi: 10.1046/j.1525-1497.2001.016009606.x.
    1. Diez-Quevedo C., Rangil T., Sanchez-Planell L., Kroenke K., Spitzer R.L. Validation and utility of the patient health questionnaire in diagnosing mental disorders in 1003 general hospital Spanish inpatients. Psychosom. Med. 2001;63:679–686. doi: 10.1097/00006842-200107000-00021.
    1. World Health Organization Regional Office for Europe . Well-Being Measures in Primary Health Care/The DepCare Project. WHO Regional Office For Europe; Stockholm, Sweden: 1998.
    1. Bonnín C.M., Yatham L.N., Michalak E.E., Martínez-Arán A., Dhanoa T., Torres I., Reinares M. Psychometric properties of the well-being index (WHO-5) Spanish version in a sample of euthymic patients with bipolar disorder. J. Affect. Disord. 2018;228:153–159. doi: 10.1016/j.jad.2017.12.006.
    1. Markland D., Ingledew D.K. The measurement of exercise motives: Factorial validity and invariance across gender of a revised Exercise Motivations Inventory. Br. J. Health Psychol. 1997;2:361–376. doi: 10.1111/j.2044-8287.1997.tb00549.x.
    1. Capdevila L., Niñerola J., Pintanel M. Motivación y actividad física: El autoinforme de motivos para la práctica de ejercicio físico (AMPEF) Rev. Psicol. Deporte. 2004;13:55–74.
    1. Rosenbaum S., Morell R., Abdel-Baki A., Ahmadpanah M., Anilkumar T.V., Baie L., Ward P.B. Assessing physical activity in people with mental illness: 23-country reliability and validity of the simple physical activity questionnaire (SIMPAQ) BMC Psychiatry. 2020;20:108. doi: 10.1186/s12888-020-2473-0.
    1. ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories ATS statement: Guidelines for the six-minute walk test. Am. J. Respir. Crit. Care Med. 2002;166:111–117. doi: 10.1164/ajrccm.166.1.at1102.
    1. Borg G. Borg’s Perceived Exertion and Pain Scales. Human Kinetics; Champaign, IL, USA: 1998.
    1. Knapen J., Van de Vliet P., Van Coppenolle H., Peuskens J., Pieters G. Evaluation of cardio-respiratory fitness and perceived exertion for patients with depressive and anxiety disorders: A study on reliability. Disabil. Rehabil. 2003;25:1312–1315. doi: 10.1080/09638280310001616277.
    1. Bohannon R.W. Sit-to-stand test for measuring performance of lower extremity muscles. Percept. Mot. Skills. 1995;80:163–166. doi: 10.2466/pms.1995.80.1.163.
    1. Trampisch U.S., Franke J., Jedamzik N., Hinrichs T., Platen P. Optimal Jamar dynamometer handle position to assess maximal isometric hand grip strength in epidemiological studies. J. Hand Surg. Am. 2012;37:2368–2373. doi: 10.1016/j.jhsa.2012.08.014.
    1. Roberts H.C., Denison H.J., Martin H.J., Patel H.P., Syddall H., Cooper C., Sayer A.A. A review of the measurement of grip strength in clinical and epidemiological studies: Towards a standardised approach. Age Ageing. 2011;40:423–429. doi: 10.1093/ageing/afr051.
    1. Josefsson T., Lindwall M., Archer T. Physical exercise intervention in depressive disorders: Meta-analysis and systematic review. Scand. J. Med. Sci. Sports. 2014;24:259–272. doi: 10.1111/sms.12050.
    1. Chan A.-W., Tetzlaff J.M., Altman D.G., Laupacis A., Gøtzsche P.C., Krleža-Jerić K., Hróbjartsson A., Mann H., Dickersin K., Berlin J., et al. SPIRIT 2013 Statement: Defining standard protocol items for clinical trials. Ann. Intern. Med. 2013;158:200–207. doi: 10.7326/0003-4819-158-3-201302050-00583.
    1. Harris P.A., Taylor R., Thielke R., Payne J., Gonzalez N., Conde J.G. Research electronic data capture (REDCap)—A metadata-driven methodology and workflow process for providing translational research informatics support. J. Biomed. Inform. 2009;42:377–381. doi: 10.1016/j.jbi.2008.08.010.
    1. Schulz K.F., Altman D.G., Moher D. CONSORT 2010 statement: Updated guidelines for reporting parallel group randomised trials. Trials. 2010;11:32. doi: 10.1186/1745-6215-11-32.

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