EMA Baseline Screening System for Therapists Who Treat Youths With Depressive Symptoms

NCT04830527 | Terminated

• 1 other identifier: 030-2020
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Youth depression is a matter of concern worldwide. It affects an important part of the young population around the world and its consequences both physically and mentally make this issue an important research field for psychologists and other health related professionals (Zuckerbrot, Cheung, Jensen, Stein \& Laraque, 2018). Two of the biggest challenges that clinicians and researchers face when dealing with youth depression are adherence and the establishment of a therapeutic alliance (TA; Nock \& Ferriter, 2005). While several treatments are available to relief depressive symptomatology in youths, a significant number do not access them for a variety of reasons (DiMatteo, Lepper \& Corgan, 2000). In the last decades, substantial research has been conducted on how youths and the general population perceive therapy, and different methods have been developed to assess clients and therapists in order to improve outcomes and other aspects of the psychotherapy process, such as feedback tools and real-time measurements like Ecological Momentary Assessment (EMA) (Shiffman, et al., 2008). With the aid of Information Communication Technologies (ICTs) and eMental Health strategies, feedback and assessment tools can be presented in a friendly manner, providing a novel way to possibly improving adherence rates and TA scores. This study aims to develop and test the effectiveness of an Ecological Momentary Assessment mobile application to improve initial adherence and TA in psychotherapy for youths with depression. The hypotheses for this trial are:

1. 1.Applying an EMA baseline screening application one week before the beginning of treatment for youth depression will significantly improve the TA.
2. 2.Applying an EMA baseline screening application one week before the beginning of treatment for youth depression will significantly improve initial adherence.

Conditions

Depressive Symptoms

Keywords

depression; therapeutic alliance; youth; Ecological Momentary Assessment; e-mental Health; e-Health; adherence

Outcome Measures

Primary Outcomes (1)

• Working Alliance Inventory, Patient Form (WAI-P)

  Likert scale with answers that range from 1 to 7. Higher scores suggest a better perception of the Therapeutic Alliance.

  Immediately after the end of first three psychotherapy sessions.

Secondary Outcomes (2)

• Working Alliance Inventory, Therapist Form (WAI-T)

  Immediately after the end of first three psychotherapy sessions.

• Assistance to sessions

  Immediately after the end of first three psychotherapy sessions.

Study Arms (2)

Intervention group

EXPERIMENTAL

Patients in experimental group will receive EMA prompts. Therapists in this group will receive a summarized PDF report before the beginning of the first psychotherapy session. The report will include graphic summarized data from the EMA prompts.

Behavioral: EMA prompting for patients; Behavioral: PDF Reports for therapists

Control group

ACTIVE COMPARATOR

Patients in control group will receive the EMA prompts in the same manner as patients in the experimental group. Therapists in this group will not receive the PDF reports, and instead will get raw scores from a screening evaluation conducted with patients in the recruitment phase of the study.

Behavioral: EMA prompting for patients

Interventions

EMA prompting for patients BEHAVIORAL

EMA prompting will consist of the delivery of the PHQ-4 and PANAS questionnaires, as well as basic identification, therapy motivations and expectations, location, current activity and social interactions. These prompts will be presented to patients during a 7 day period, 5 times per day.

Control group; Intervention group

PDF Reports for therapists BEHAVIORAL

After the patients' EMA data is collected, a previously designed R script will summarize and transform the data into a brief and graphic report for therapists in the experimental arm of the study. These reports are intended to provide detailed information about the patients' mood, anxiety levels, positive and negative affects, as well as crossed data such as mood according to location, anxiety according to activity, etc.

Intervention group

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Owning a mobile phone with permanent access to the internet,
• Scoring from eleven to nineteen points in the PHQ-9 questionnaire.
• Having completed the eighth grade of basic education.

You may not qualify if:

• Being diagnosed with Depression with psychotic symptoms,
• Having a depressive episode as part of a bipolar disorder diagnosis
• Having suicidal thoughts and/or behaviour as measured by the PHQ-9 and evaluated by the physician.
• Alcohol and/or substance abuse.
• \- Having 1 or more years of clinical experience.
• Having less than 1 year of clinical experience.
• Having participated in the design of PDF reports.

Sponsors & Collaborators

• Vania Martínez-Nahuel: lead
• ANID - Millennium Science Initiative Program - NCS17_03 Millennium Nucleus to Improve the Mental Health of Adolescents and Youths (Imhay), Santiago, Chile: collaborator
• Millennium Institute on Immunology and Immunotherapy: collaborator
• Center for Psychotherapy Research, University Hospital Heidelberg, Heidelberg, Germany: collaborator

Study Sites (1)

CEMERA, Faculty of Medicine, Universidad de Chile

Santiago, Santiago Metropolitan, 8380455, Chile

Location

Related Publications (32)

• Abras, C., Maloney-Krichmar, D., Preece, J. (2004) User-Centered Design. In Bainbridge, W. Encyclopedia of Human-Computer Interaction. Thousand Oaks: Sage Publications.

  BACKGROUND

• Borghero F, Martinez V, Zitko P, Vohringer PA, Cavada G, Rojas G. [Screening depressive episodes in adolescents. Validation of the Patient Health Questionnaire-9 (PHQ-9)]. Rev Med Chil. 2018 Apr;146(4):479-486. doi: 10.4067/s0034-98872018000400479. Spanish.

  PMID: 29999123 BACKGROUND

• Cipriani A, Zhou X, Del Giovane C, Hetrick SE, Qin B, Whittington C, Coghill D, Zhang Y, Hazell P, Leucht S, Cuijpers P, Pu J, Cohen D, Ravindran AV, Liu Y, Michael KD, Yang L, Liu L, Xie P. Comparative efficacy and tolerability of antidepressants for major depressive disorder in children and adolescents: a network meta-analysis. Lancet. 2016 Aug 27;388(10047):881-90. doi: 10.1016/S0140-6736(16)30385-3. Epub 2016 Jun 8.

  PMID: 27289172 BACKGROUND

• Clark MS, Jansen KL, Cloy JA. Treatment of childhood and adolescent depression. Am Fam Physician. 2012 Sep 1;86(5):442-8.

  PMID: 22963063 BACKGROUND

• Cox GR, Callahan P, Churchill R, Hunot V, Merry SN, Parker AG, Hetrick SE. Psychological therapies versus antidepressant medication, alone and in combination for depression in children and adolescents. Cochrane Database Syst Rev. 2014 Nov 30;2014(11):CD008324. doi: 10.1002/14651858.CD008324.pub3.

  PMID: 25433518 BACKGROUND

• David-Ferdon C, Kaslow NJ. Evidence-based psychosocial treatments for child and adolescent depression. J Clin Child Adolesc Psychol. 2008 Jan;37(1):62-104. doi: 10.1080/15374410701817865.

  PMID: 18444054 BACKGROUND

• Eapen V, Crncec R. Strategies and challenges in the management of adolescent depression. Curr Opin Psychiatry. 2012 Jan;25(1):7-13. doi: 10.1097/YCO.0b013e32834de3bd.

  PMID: 22156932 BACKGROUND

• Fernández, O., Pérez, C., Gloger, S., Krause, M., (2015) Importancia de los cambios iniciales en psicoterapia con jovenes, Terapia Psicológica, (33)3, pp. 247 - 255.

  BACKGROUND

• Fernández, O. M., Herrera-Salinas, P. & Escobar-Martínez, M. J. (2016). youthes en Psicoterapia: Su Representación de la Relación Terapéutica. Revista Latinoamericana de Ciencias Sociales, Niñez y Juventud, 14 (1), pp. 559-575.

  BACKGROUND

• Fernandez, O.M., Krause, M., & Pérez, J.C. (2016). Therapeutic alliance in the initial phase of psychotherapy with ado- lescents: different perspectives and their association with therapeutic outcomes. Research in Psychotherapy: Psychopathology, Process and Outcome, 19(1), 1-9. doi: 10.4081/ripppo.2016.180

  BACKGROUND

• Goodyer IM, Reynolds S, Barrett B, Byford S, Dubicka B, Hill J, Holland F, Kelvin R, Midgley N, Roberts C, Senior R, Target M, Widmer B, Wilkinson P, Fonagy P. Cognitive-behavioural therapy and short-term psychoanalytic psychotherapy versus brief psychosocial intervention in adolescents with unipolar major depression (IMPACT): a multicentre, pragmatic, observer-blind, randomised controlled trial. Health Technol Assess. 2017 Mar;21(12):1-94. doi: 10.3310/hta21120.

  PMID: 28394249 BACKGROUND

• Hatcher, R., & Gillaspy, J., (2006) Development and validation of a revised short version of the working alliance inventory, Psychotherapy Research, 16:1, 12-25, DOI: 10.1080/10503300500352500

  BACKGROUND

• Kroenke K, Spitzer RL, Williams JB. The Patient Health Questionnaire-2: validity of a two-item depression screener. Med Care. 2003 Nov;41(11):1284-92. doi: 10.1097/01.MLR.0000093487.78664.3C.

  PMID: 14583691 BACKGROUND

• Kroenke K, Spitzer RL, Williams JB, Monahan PO, Lowe B. Anxiety disorders in primary care: prevalence, impairment, comorbidity, and detection. Ann Intern Med. 2007 Mar 6;146(5):317-25. doi: 10.7326/0003-4819-146-5-200703060-00004.

  PMID: 17339617 BACKGROUND

• Kelders SM, Kok RN, Ossebaard HC, Van Gemert-Pijnen JE. Persuasive system design does matter: a systematic review of adherence to web-based interventions. J Med Internet Res. 2012 Nov 14;14(6):e152. doi: 10.2196/jmir.2104.

  PMID: 23151820 BACKGROUND

• Lal S, Adair CE. E-mental health: a rapid review of the literature. Psychiatr Serv. 2014 Jan 1;65(1):24-32. doi: 10.1176/appi.ps.201300009.

  PMID: 24081188 BACKGROUND

• Lambert MJ, Whipple JL, Smart DW, Vermeersch DA, Nielsen SL, Hawkins EJ. The effects of providing therapists with feedback on patient progress during psychotherapy: are outcomes enhanced? Psychother Res. 2001 Mar;11(1):49-68. doi: 10.1080/713663852.

  PMID: 25849877 BACKGROUND

• Lambert MJ. Maximizing Psychotherapy Outcome beyond Evidence-Based Medicine. Psychother Psychosom. 2017;86(2):80-89. doi: 10.1159/000455170. Epub 2017 Feb 10.

  PMID: 28183083 BACKGROUND

• Luciano JV, Bertsch J, Salvador-Carulla L, Tomas JM, Fernandez A, Pinto-Meza A, Haro JM, Palao DJ, Serrano-Blanco A. Factor structure, internal consistency and construct validity of the Sheehan Disability Scale in a Spanish primary care sample. J Eval Clin Pract. 2010 Oct;16(5):895-901. doi: 10.1111/j.1365-2753.2009.01211.x.

  PMID: 20626541 BACKGROUND

• Lewinsohn PM, Clarke GN. Psychosocial treatments for adolescent depression. Clin Psychol Rev. 1999 Apr;19(3):329-42. doi: 10.1016/s0272-7358(98)00055-5.

  PMID: 10097874 BACKGROUND

• Michael KD, Crowley SL. How effective are treatments for child and adolescent depression? A meta-analytic review. Clin Psychol Rev. 2002 Mar;22(2):247-69. doi: 10.1016/s0272-7358(01)00089-7.

  PMID: 11806021 BACKGROUND

• Nock MK, Ferriter C. Parent management of attendance and adherence in child and adolescent therapy: a conceptual and empirical review. Clin Child Fam Psychol Rev. 2005 Jun;8(2):149-66. doi: 10.1007/s10567-005-4753-0.

  PMID: 15984084 BACKGROUND

• O'Dea B, Calear AL, Perry Y. Is e-health the answer to gaps in adolescent mental health service provision? Curr Opin Psychiatry. 2015 Jul;28(4):336-42. doi: 10.1097/YCO.0000000000000170.

  PMID: 26001926 BACKGROUND

• Pacheco, B. & Aránguiz, C., (2011) Factores relacionados a la adherencia a tratamiento en youthes con depresión, Revista Chilena de Neuro-Psiquiatría, 49(1), pp. 69-78.

  BACKGROUND

• Riper H, Andersson G, Christensen H, Cuijpers P, Lange A, Eysenbach G. Theme issue on e-mental health: a growing field in internet research. J Med Internet Res. 2010 Dec 19;12(5):e74. doi: 10.2196/jmir.1713.

  PMID: 21169177 BACKGROUND

• Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57.

  PMID: 9881538 BACKGROUND

• Shimokawa K, Lambert MJ, Smart DW. Enhancing treatment outcome of patients at risk of treatment failure: meta-analytic and mega-analytic review of a psychotherapy quality assurance system. J Consult Clin Psychol. 2010 Jun;78(3):298-311. doi: 10.1037/a0019247.

  PMID: 20515206 BACKGROUND

• Shiffman S, Stone AA, Hufford MR. Ecological momentary assessment. Annu Rev Clin Psychol. 2008;4:1-32. doi: 10.1146/annurev.clinpsy.3.022806.091415.

  PMID: 18509902 BACKGROUND

• Shirk SR, Karver M. Prediction of treatment outcome from relationship variables in child and adolescent therapy: a meta-analytic review. J Consult Clin Psychol. 2003 Jun;71(3):452-64. doi: 10.1037/0022-006x.71.3.452.

  PMID: 12795570 BACKGROUND

• Silk JS, Forbes EE, Whalen DJ, Jakubcak JL, Thompson WK, Ryan ND, Axelson DA, Birmaher B, Dahl RE. Daily emotional dynamics in depressed youth: a cell phone ecological momentary assessment study. J Exp Child Psychol. 2011 Oct;110(2):241-57. doi: 10.1016/j.jecp.2010.10.007. Epub 2010 Nov 26.

  PMID: 21112595 BACKGROUND

• Weersing VR, Brent DA, Rozenman MS, Gonzalez A, Jeffreys M, Dickerson JF, Lynch FL, Porta G, Iyengar S. Brief Behavioral Therapy for Pediatric Anxiety and Depression in Primary Care: A Randomized Clinical Trial. JAMA Psychiatry. 2017 Jun 1;74(6):571-578. doi: 10.1001/jamapsychiatry.2017.0429.

  PMID: 28423145 BACKGROUND

• Weisz JR, Kuppens S, Ng MY, Eckshtain D, Ugueto AM, Vaughn-Coaxum R, Jensen-Doss A, Hawley KM, Krumholz Marchette LS, Chu BC, Weersing VR, Fordwood SR. What five decades of research tells us about the effects of youth psychological therapy: A multilevel meta-analysis and implications for science and practice. Am Psychol. 2017 Feb-Mar;72(2):79-117. doi: 10.1037/a0040360.

  PMID: 28221063 BACKGROUND

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: March 30, 2021
• First Posted: April 5, 2021
• Study Start: November 24, 2020
• Primary Completion: November 24, 2021
• Study Completion: November 30, 2021
• Last Updated: May 23, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)