PERSONAE - a Personalized Online Treatment of Depression

NCT07113548 | Recruiting DMC

• 2 other identifiers: CIV-25-01-0504942077-00009B
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to determine whether a personalized online treatment for depression, delivered via an app (PERSONAE), is effective in treating mild to moderate depression in adults. The study will also assess the safety of the Monsenso app. The main questions it aims to answer are: Does the PERSONAE intervention reduce depression scores compared to standard internet-based treatment for depression? What challenges do participants experience when using the PERSONAE intervention? Researchers will compare PERSONAE to Treatment As Usual (a standard, one-size-fits-all treatment) to evaluate whether PERSONAE is more effective in treating mild to moderate depression. Participants will: Complete a 12-week online treatment program based on cognitive behavioral therapy (CBT). Undergo an intake assessment and complete weekly questionnaires. Receive guidance from a clinical psychologist tailored to their individual needs

Conditions

Depression - Major Depressive Disorder

Keywords

Depression; iCBT; randomized controlled trial; personalized; stepped-care; internet-based

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the mean depression score on the 9-item Patient Health Questionnaire (PHQ-9).

  The Patient Health Questionnaire-9 (PHQ-9) has a total score range of 0-27, with higher scores indicating more severe depressive symptoms. The questionnaire will be administered via automated REDCap surveys at baseline, post-treatment, and at 3-, 6-, and 12-month follow-ups, as well as during treatment through the Minddistrict (TAU) and Monsenso (PERSONAE) programs. The PHQ-9 evaluates nine core symptoms of depression.

  From enrollment to 12 weeks of treatment, plus follow up at 3, 6, and 12 months

Secondary Outcomes (1)

• Adherence rates

  This will be assessed at the individual patient level, once the patient is no longer active in treatment-either due to completing the 12-week program or discontinuing active engagement with the intervention.

Study Arms (2)

PERSONAE

EXPERIMENTAL

Personalized treatment arm

Behavioral: Personalized iCBT for depression

Treatment As Usual

ACTIVE COMPARATOR

Standard iCBT

Behavioral: Standard iCBT

Interventions

Personalized iCBT for depression BEHAVIORAL

Participants receive 12 sessions of personalized treatment in an online iCBT program. The treatment includes the option for weekly written feedback from a psychologist, or video-based interventions depending on the participant's current status. The content of the 12-week program is tailored to the participant's individual symptom profile. The treatment incorporates elements from standard Cognitive Behavioral Therapy (CBT), Acceptance and Commitment Therapy (ACT), Compassion-Focused Therapy (CFT), and Positive Activity Interventions (PAT). The program consists of nine modules, each targeting a specific area: Rumination, Anhedonia, Tearfulness and emotional regulation, Sleep problems, Difficulty concentrating, Eating issues, Low energy, Social withdrawal, Self-critical thinking, The treatment concludes with support aimed at preventing relapse.

PERSONAE

Standard iCBT BEHAVIORAL

Standard iCBT consisting of a "one size fits all"" progression of cognitive behavioral therapy over 12 weeks. This includes: Introduction to Online Cognitive Behavioral Therapy Start of Treatment Rumination Activity Monitoring Activity Planning Cognitive Restructuring Behavioral Experiment I Behavioral Experiment II Core Beliefs I Core Beliefs II Relapse Prevention

Treatment As Usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older.
• Patient Health Questionnaire-9 items (PHQ-9) \>4 AND \<22.
• Any gender.
• Meeting the diagnostic criteria of the International Classification of Diseases and Related Health Problems 10th edition for major depressive disorder

You may not qualify if:

• Unable to speak and/or read Danish.
• No access to a smartphone.
• Pregnant or breastfeeding.
• Heightened suicide risk as per the PHQ-9 (item 9 \>1) and Quick Inventory of Depressive Symptoms (QIDS) item 12.
• Comorbid disorders: Diagnosed substance dependence, bipolar affective disorder, psychotic illness, or obsessive-compulsive disorder.
• Not currently in therapeutic treatment for anxiety or depression.

Sponsors & Collaborators

• Region of Southern Denmark: lead

Study Sites (1)

Center for Digital Psychiatry

Odense, 5000, Denmark

RECRUITING

Related Publications (52)

• Videbech P, Deleuran A. The Danish Depression Database. Clin Epidemiol. 2016 Oct 25;8:475-478. doi: 10.2147/CLEP.S100298. eCollection 2016.

  PMID: 27843341 BACKGROUND

• Andersson G, Bergstrom J, Hollandare F, Carlbring P, Kaldo V, Ekselius L. Internet-based self-help for depression: randomised controlled trial. Br J Psychiatry. 2005 Nov;187:456-61. doi: 10.1192/bjp.187.5.456.

  PMID: 16260822 BACKGROUND

• Andrews G, Cuijpers P, Craske MG, McEvoy P, Titov N. Computer therapy for the anxiety and depressive disorders is effective, acceptable and practical health care: a meta-analysis. PLoS One. 2010 Oct 13;5(10):e13196. doi: 10.1371/journal.pone.0013196.

  PMID: 20967242 BACKGROUND

• Barney LJ, Griffiths KM, Jorm AF, Christensen H. Stigma about depression and its impact on help-seeking intentions. Aust N Z J Psychiatry. 2006 Jan;40(1):51-4. doi: 10.1080/j.1440-1614.2006.01741.x.

  PMID: 16403038 BACKGROUND

• Brown LA, Gaudiano BA, Miller IW. Investigating the similarities and differences between practitioners of second- and third-wave cognitive-behavioral therapies. Behav Modif. 2011 Mar;35(2):187-200. doi: 10.1177/0145445510393730.

  PMID: 21324946 BACKGROUND

• Buch AM, Liston C. Dissecting diagnostic heterogeneity in depression by integrating neuroimaging and genetics. Neuropsychopharmacology. 2021 Jan;46(1):156-175. doi: 10.1038/s41386-020-00789-3. Epub 2020 Aug 11.

  PMID: 32781460 BACKGROUND

• Carlbring P, Andersson G, Cuijpers P, Riper H, Hedman-Lagerlof E. Internet-based vs. face-to-face cognitive behavior therapy for psychiatric and somatic disorders: an updated systematic review and meta-analysis. Cogn Behav Ther. 2018 Jan;47(1):1-18. doi: 10.1080/16506073.2017.1401115. Epub 2017 Dec 7.

  PMID: 29215315 BACKGROUND

• Cuijpers P, Reijnders M, Karyotaki E, de Wit L, Ebert DD. Negative effects of psychotherapies for adult depression: A meta-analysis of deterioration rates. J Affect Disord. 2018 Oct 15;239:138-145. doi: 10.1016/j.jad.2018.05.050. Epub 2018 Jul 3.

  PMID: 30005327 BACKGROUND

• Donkin L, Glozier N. Motivators and motivations to persist with online psychological interventions: a qualitative study of treatment completers. J Med Internet Res. 2012 Jun 22;14(3):e91. doi: 10.2196/jmir.2100.

  PMID: 22743581 BACKGROUND

• Etzelmueller A, Vis C, Karyotaki E, Baumeister H, Titov N, Berking M, Cuijpers P, Riper H, Ebert DD. Effects of Internet-Based Cognitive Behavioral Therapy in Routine Care for Adults in Treatment for Depression and Anxiety: Systematic Review and Meta-Analysis. J Med Internet Res. 2020 Aug 31;22(8):e18100. doi: 10.2196/18100.

  PMID: 32865497 BACKGROUND

• Folker AP, Mathiasen K, Lauridsen SM, Stenderup E, Dozeman E, Folker MP. Implementing internet-delivered cognitive behavior therapy for common mental health disorders: A comparative case study of implementation challenges perceived by therapists and managers in five European internet services. Internet Interv. 2018 Feb 6;11:60-70. doi: 10.1016/j.invent.2018.02.001. eCollection 2018 Mar.

  PMID: 30135761 BACKGROUND

• Goldberg D. The heterogeneity of "major depression". World Psychiatry. 2011 Oct;10(3):226-8. doi: 10.1002/j.2051-5545.2011.tb00061.x. No abstract available.

  PMID: 21991283 BACKGROUND

• Grandes G, Montoya I, Arietaleanizbeaskoa MS, Arce V, Sanchez A; MAS Group. The burden of mental disorders in primary care. Eur Psychiatry. 2011 Oct;26(7):428-35. doi: 10.1016/j.eurpsy.2010.11.002. Epub 2011 Feb 8.

  PMID: 21306876 BACKGROUND

• Gunter RW, Whittal ML. Dissemination of cognitive-behavioral treatments for anxiety disorders: Overcoming barriers and improving patient access. Clin Psychol Rev. 2010 Mar;30(2):194-202. doi: 10.1016/j.cpr.2009.11.001. Epub 2009 Nov 10.

  PMID: 19942331 BACKGROUND

• Gustavsson A, Svensson M, Jacobi F, Allgulander C, Alonso J, Beghi E, Dodel R, Ekman M, Faravelli C, Fratiglioni L, Gannon B, Jones DH, Jennum P, Jordanova A, Jonsson L, Karampampa K, Knapp M, Kobelt G, Kurth T, Lieb R, Linde M, Ljungcrantz C, Maercker A, Melin B, Moscarelli M, Musayev A, Norwood F, Preisig M, Pugliatti M, Rehm J, Salvador-Carulla L, Schlehofer B, Simon R, Steinhausen HC, Stovner LJ, Vallat JM, Van den Bergh P, van Os J, Vos P, Xu W, Wittchen HU, Jonsson B, Olesen J; CDBE2010Study Group. Cost of disorders of the brain in Europe 2010. Eur Neuropsychopharmacol. 2011 Oct;21(10):718-79. doi: 10.1016/j.euroneuro.2011.08.008. Epub 2011 Sep 15.

  PMID: 21924589 BACKGROUND

• Isabelle Mairey, S. R., Marie Borring Klitgaard og Lau Caspar Thygesen,. (2022). Sygdomsbyrden i Danmark - sygdomme. København: Sundhedsstyrelsen Islands Brygge 67 2300 København S

  BACKGROUND

• Mathiasen K, Riper H, Andersen TE, Roessler KK. Guided Internet-Based Cognitive Behavioral Therapy for Adult Depression and Anxiety in Routine Secondary Care: Observational Study. J Med Internet Res. 2018 Nov 28;20(11):e10927. doi: 10.2196/10927.

  PMID: 30487118 BACKGROUND

• Richards D, Richardson T. Computer-based psychological treatments for depression: a systematic review and meta-analysis. Clin Psychol Rev. 2012 Jun;32(4):329-42. doi: 10.1016/j.cpr.2012.02.004. Epub 2012 Feb 28.

  PMID: 22466510 BACKGROUND

• Sasso KE, Strunk DR. Thin slice ratings of client characteristics in intake assessments: predicting symptom change and dropout in cognitive therapy for depression. Behav Res Ther. 2013 Aug;51(8):443-50. doi: 10.1016/j.brat.2013.04.007. Epub 2013 May 7.

  PMID: 23747583 BACKGROUND

• Thase ME. The multifactorial presentation of depression in acute care. J Clin Psychiatry. 2013;74 Suppl 2:3-8. doi: 10.4088/JCP.12084su1c.01.

  PMID: 24191971 BACKGROUND

• Titov N, Dear B, Nielssen O, Staples L, Hadjistavropoulos H, Nugent M, Adlam K, Nordgreen T, Bruvik KH, Hovland A, Repal A, Mathiasen K, Kraepelien M, Blom K, Svanborg C, Lindefors N, Kaldo V. ICBT in routine care: A descriptive analysis of successful clinics in five countries. Internet Interv. 2018 Jul 26;13:108-115. doi: 10.1016/j.invent.2018.07.006. eCollection 2018 Sep.

  PMID: 30206525 BACKGROUND

• van Ballegooijen W, Cuijpers P, van Straten A, Karyotaki E, Andersson G, Smit JH, Riper H. Adherence to Internet-based and face-to-face cognitive behavioural therapy for depression: a meta-analysis. PLoS One. 2014 Jul 16;9(7):e100674. doi: 10.1371/journal.pone.0100674. eCollection 2014.

  PMID: 25029507 BACKGROUND

• Setia S, Furtner D, Bendahmane M, Tichy M. Success4life Youth Empowerment for Promoting Well-being and Boosting Mental Health: Protocol for an Experimental Study. JMIR Res Protoc. 2022 Sep 14;11(9):e38463. doi: 10.2196/38463.

  PMID: 36041997 BACKGROUND

• Vygotsky, L. S., & Cole, M. (1978). Mind in society: Development of higher psychological processes. Harvard University Press.

  BACKGROUND

• Shafran R, Clark DM, Fairburn CG, Arntz A, Barlow DH, Ehlers A, Freeston M, Garety PA, Hollon SD, Ost LG, Salkovskis PM, Williams JM, Wilson GT. Mind the gap: Improving the dissemination of CBT. Behav Res Ther. 2009 Nov;47(11):902-9. doi: 10.1016/j.brat.2009.07.003. Epub 2009 Aug 6.

  PMID: 19664756 BACKGROUND

• Kuyken W, Warren FC, Taylor RS, Whalley B, Crane C, Bondolfi G, Hayes R, Huijbers M, Ma H, Schweizer S, Segal Z, Speckens A, Teasdale JD, Van Heeringen K, Williams M, Byford S, Byng R, Dalgleish T. Efficacy of Mindfulness-Based Cognitive Therapy in Prevention of Depressive Relapse: An Individual Patient Data Meta-analysis From Randomized Trials. JAMA Psychiatry. 2016 Jun 1;73(6):565-74. doi: 10.1001/jamapsychiatry.2016.0076.

  PMID: 27119968 BACKGROUND

• Rosendahl, H., Davidsen, M., Møller, S. R., Román, J. E. I., Kragelund, K., Christensen, A. I., & Ekholm, O. (2022). Danskernes sundhed: Den nationale sundhedsprofil 2021

  BACKGROUND

• Reynolds CF 3rd, Cuijpers P, Patel V, Cohen A, Dias A, Chowdhary N, Okereke OI, Dew MA, Anderson SJ, Mazumdar S, Lotrich F, Albert SM. Early intervention to reduce the global health and economic burden of major depression in older adults. Annu Rev Public Health. 2012 Apr;33:123-35. doi: 10.1146/annurev-publhealth-031811-124544.

  PMID: 22429161 BACKGROUND

• Pedersen MK, Mohammadi R, Mathiasen K, Elmose M. Internet-based cognitive behavioral therapy for anxiety in an outpatient specialized care setting: A qualitative study of the patients' experience of the therapy. Scand J Psychol. 2020 Dec;61(6):846-854. doi: 10.1111/sjop.12665. Epub 2020 Jul 23.

  PMID: 32705703 BACKGROUND

• Mathiasen K, Andersen TE, Lichtenstein MB, Ehlers LH, Riper H, Kleiboer A, Roessler KK. The Clinical Effectiveness of Blended Cognitive Behavioral Therapy Compared With Face-to-Face Cognitive Behavioral Therapy for Adult Depression: Randomized Controlled Noninferiority Trial. J Med Internet Res. 2022 Sep 7;24(9):e36577. doi: 10.2196/36577.

  PMID: 36069798 BACKGROUND

• Lutz W, Arndt A, Rubel J, Berger T, Schroder J, Spath C, Meyer B, Greiner W, Grafe V, Hautzinger M, Fuhr K, Rose M, Nolte S, Lowe B, Hohagen F, Klein JP, Moritz S. Defining and Predicting Patterns of Early Response in a Web-Based Intervention for Depression. J Med Internet Res. 2017 Jun 9;19(6):e206. doi: 10.2196/jmir.7367.

  PMID: 28600278 BACKGROUND

• Laynard, R., Clark, D., Knapp, M., & Mayraz, G. (2007). Cost-benefit analysis of psychological therapy. National Institute Economic Review, 202(1), 90-98.

  BACKGROUND

• Lawler K, Earley C, Timulak L, Enrique A, Richards D. Dropout From an Internet-Delivered Cognitive Behavioral Therapy Intervention for Adults With Depression and Anxiety: Qualitative Study. JMIR Form Res. 2021 Nov 12;5(11):e26221. doi: 10.2196/26221.

  PMID: 34766909 BACKGROUND

• Kuyken W, Watkins E, Holden E, White K, Taylor RS, Byford S, Evans A, Radford S, Teasdale JD, Dalgleish T. How does mindfulness-based cognitive therapy work? Behav Res Ther. 2010 Nov;48(11):1105-12. doi: 10.1016/j.brat.2010.08.003. Epub 2010 Aug 13.

  PMID: 20810101 BACKGROUND

• Klein T, Breilmann J, Schneider C, Girlanda F, Fiedler I, Dawson S, Crippa A, Priebe S, Barbui C, Becker T, Kosters M. Dose-response relationship in cognitive behavioral therapy for depression: A nonlinear metaregression analysis. J Consult Clin Psychol. 2024 May;92(5):296-309. doi: 10.1037/ccp0000879.

  PMID: 38829329 BACKGROUND

• Karyotaki E, Efthimiou O, Miguel C, Bermpohl FMG, Furukawa TA, Cuijpers P; Individual Patient Data Meta-Analyses for Depression (IPDMA-DE) Collaboration; Riper H, Patel V, Mira A, Gemmil AW, Yeung AS, Lange A, Williams AD, Mackinnon A, Geraedts A, van Straten A, Meyer B, Bjorkelund C, Knaevelsrud C, Beevers CG, Botella C, Strunk DR, Mohr DC, Ebert DD, Kessler D, Richards D, Littlewood E, Forsell E, Feng F, Wang F, Andersson G, Hadjistavropoulos H, Christensen H, Ezawa ID, Choi I, Rosso IM, Klein JP, Shumake J, Garcia-Campayo J, Milgrom J, Smith J, Montero-Marin J, Newby JM, Breton-Lopez J, Schneider J, Vernmark K, Bucker L, Sheeber LB, Warmerdam L, Farrer L, Heinrich M, Huibers MJH, Kivi M, Kraepelien M, Forand NR, Pugh N, Lindefors N, Lintvedt O, Zagorscak P, Carlbring P, Phillips R, Johansson R, Kessler RC, Brabyn S, Perini S, Rauch SL, Gilbody S, Moritz S, Berger T, Pop V, Kaldo V, Spek V, Forsell Y. Internet-Based Cognitive Behavioral Therapy for Depression: A Systematic Review and Individual Patient Data Network Meta-analysis. JAMA Psychiatry. 2021 Apr 1;78(4):361-371. doi: 10.1001/jamapsychiatry.2020.4364.

  PMID: 33471111 BACKGROUND

• Karyotaki E, Kemmeren L, Riper H, Twisk J, Hoogendoorn A, Kleiboer A, Mira A, Mackinnon A, Meyer B, Botella C, Littlewood E, Andersson G, Christensen H, Klein JP, Schroder J, Breton-Lopez J, Scheider J, Griffiths K, Farrer L, Huibers MJH, Phillips R, Gilbody S, Moritz S, Berger T, Pop V, Spek V, Cuijpers P. Is self-guided internet-based cognitive behavioural therapy (iCBT) harmful? An individual participant data meta-analysis. Psychol Med. 2018 Nov;48(15):2456-2466. doi: 10.1017/S0033291718000648. Epub 2018 Mar 15.

  PMID: 29540243 BACKGROUND

• Karyotaki E, Riper H, Twisk J, Hoogendoorn A, Kleiboer A, Mira A, Mackinnon A, Meyer B, Botella C, Littlewood E, Andersson G, Christensen H, Klein JP, Schroder J, Breton-Lopez J, Scheider J, Griffiths K, Farrer L, Huibers MJ, Phillips R, Gilbody S, Moritz S, Berger T, Pop V, Spek V, Cuijpers P. Efficacy of Self-guided Internet-Based Cognitive Behavioral Therapy in the Treatment of Depressive Symptoms: A Meta-analysis of Individual Participant Data. JAMA Psychiatry. 2017 Apr 1;74(4):351-359. doi: 10.1001/jamapsychiatry.2017.0044.

  PMID: 28241179 BACKGROUND

• Karyotaki E, Kleiboer A, Smit F, Turner DT, Pastor AM, Andersson G, Berger T, Botella C, Breton JM, Carlbring P, Christensen H, de Graaf E, Griffiths K, Donker T, Farrer L, Huibers MJ, Lenndin J, Mackinnon A, Meyer B, Moritz S, Riper H, Spek V, Vernmark K, Cuijpers P. Predictors of treatment dropout in self-guided web-based interventions for depression: an 'individual patient data' meta-analysis. Psychol Med. 2015 Oct;45(13):2717-26. doi: 10.1017/S0033291715000665. Epub 2015 Apr 17.

  PMID: 25881626 BACKGROUND

• Hayes, S. C., Strosahl, K. D., & Wilson, K. G. (1999). Acceptance and commitment therapy (Vol. 6). Guilford Press

  BACKGROUND

• Gilbert P. The origins and nature of compassion focused therapy. Br J Clin Psychol. 2014 Mar;53(1):6-41. doi: 10.1111/bjc.12043.

  PMID: 24588760 BACKGROUND

• Cuijpers P, Noma H, Karyotaki E, Vinkers CH, Cipriani A, Furukawa TA. A network meta-analysis of the effects of psychotherapies, pharmacotherapies and their combination in the treatment of adult depression. World Psychiatry. 2020 Feb;19(1):92-107. doi: 10.1002/wps.20701.

  PMID: 31922679 BACKGROUND

• Chand SP, Kuckel DP, Huecker MR. Cognitive Behavior Therapy. 2023 May 23. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK470241/

  PMID: 29261869 BACKGROUND

• Butler AC, Chapman JE, Forman EM, Beck AT. The empirical status of cognitive-behavioral therapy: a review of meta-analyses. Clin Psychol Rev. 2006 Jan;26(1):17-31. doi: 10.1016/j.cpr.2005.07.003. Epub 2005 Sep 30.

  PMID: 16199119 BACKGROUND

• Bliss, J., Askew, M., & Macrae, S. (1996). Effective teaching and learning: Scaffolding revisited. Oxford Review of Education, 22(1), 37-61.

  BACKGROUND

• Beck, J. S. (2020). Cognitive behavior therapy: Basics and beyond (3rd ed.). Guilford Publications.

  BACKGROUND

• Beck, A. T. (1979). Cognitive therapy of depression. Guilford Press.

  BACKGROUND

• Barrett MS, Chua WJ, Crits-Christoph P, Gibbons MB, Casiano D, Thompson D. EARLY WITHDRAWAL FROM MENTAL HEALTH TREATMENT: IMPLICATIONS FOR PSYCHOTHERAPY PRACTICE. Psychotherapy (Chic). 2008 Jun 1;45(2):247-267. doi: 10.1037/0033-3204.45.2.247.

  PMID: 19838318 BACKGROUND

• Barak, A., Hen, L., Boniel-Nissim, M., & Shapira, N. A. (2008). A comprehensive review and a meta-analysis of the effectiveness of internet-based psychotherapeutic interventions. Journal of Technology in Human Services, 26(2-4), 109-160

  BACKGROUND

• Andrews G, Basu A, Cuijpers P, Craske MG, McEvoy P, English CL, Newby JM. Computer therapy for the anxiety and depression disorders is effective, acceptable and practical health care: An updated meta-analysis. J Anxiety Disord. 2018 Apr;55:70-78. doi: 10.1016/j.janxdis.2018.01.001. Epub 2018 Feb 1.

  PMID: 29422409 BACKGROUND

• Alonso J, Codony M, Kovess V, Angermeyer MC, Katz SJ, Haro JM, De Girolamo G, De Graaf R, Demyttenaere K, Vilagut G, Almansa J, Lepine JP, Brugha TS. Population level of unmet need for mental healthcare in Europe. Br J Psychiatry. 2007 Apr;190:299-306. doi: 10.1192/bjp.bp.106.022004.

  PMID: 17401035 BACKGROUND

• Alonso J, Angermeyer MC, Bernert S, Bruffaerts R, Brugha TS, Bryson H, de Girolamo G, Graaf R, Demyttenaere K, Gasquet I, Haro JM, Katz SJ, Kessler RC, Kovess V, Lepine JP, Ormel J, Polidori G, Russo LJ, Vilagut G, Almansa J, Arbabzadeh-Bouchez S, Autonell J, Bernal M, Buist-Bouwman MA, Codony M, Domingo-Salvany A, Ferrer M, Joo SS, Martinez-Alonso M, Matschinger H, Mazzi F, Morgan Z, Morosini P, Palacin C, Romera B, Taub N, Vollebergh WA; ESEMeD/MHEDEA 2000 Investigators, European Study of the Epidemiology of Mental Disorders (ESEMeD) Project. Prevalence of mental disorders in Europe: results from the European Study of the Epidemiology of Mental Disorders (ESEMeD) project. Acta Psychiatr Scand Suppl. 2004;(420):21-7. doi: 10.1111/j.1600-0047.2004.00327.x.

  PMID: 15128384 BACKGROUND

Related Links

• The home page of the PERSONAE project

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Kim Mathiasen, Ph.d.

  University of Southern Denmark & Aarhus University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Trine TH Sainte-Marie, ph.d. student

CONTACT

+ 42209922; trine.theresa.holmberg@rsyd.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Since the two conditions are easily distinguishable, care providers and participants will remain blinded until the participant has completed the baseline questionnaires and has been randomized. After randomization, unblinding is unavoidable.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: August 8, 2025
• Study Start: June 10, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Q3 2025 to Q2 2027
• Access Criteria: Pepijn van de Ven is a Professor in the Department of Electronic and Computer Engineering at the University of Limerick. Data will be shared via Jupyter. A data use agreement has been approved, and each participant provides separate consent for data sharing. If a participant declines, their data will be excluded prior to sharing.

Locations

DK (1)