Clinical trial NCT04830527: EMA Baseline Screening System for Therapists Who Treat Youths With Depressive Symptoms
Official title: Development and Evaluation of an Ecological Momentary Assessment (EMA) Baseline Screening System for Therapists Who Treat Youths With Depressive Symptoms
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Depressive Symptoms
Keywords: depression
therapeutic alliance
youth
Ecological Momentary Assessment
e-mental Health
e-Health
adherence
Lead sponsor: University of Chile
Sponsor class: OTHER
Collaborators: name: ANID - Millennium Science Initiative Program - NCS17_03 Millennium Nucleus to Improve the Mental Health of Adolescents and Youths (Imhay), Santiago, Chile
name: Millennium Institute on Immunology and Immunotherapy
name: Center for Psychotherapy Research, University Hospital Heidelberg, Heidelberg, Germany
First posted: 2021-04-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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


Eligibility criteria: Inclusion Criteria for Patients:

* 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.

Exclusion Criteria for Patients:

* 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.

Inclusion Criteria for Therapists:

- Having 1 or more years of clinical experience.

Exclusion Criteria for Therapists:

* Having less than 1 year of clinical experience.
* Having participated in the design of PDF reports.

Primary outcomes:
measure: Working Alliance Inventory, Patient Form (WAI-P)
timeFrame: Immediately after the end of first three psychotherapy sessions.
Secondary outcomes:
measure: Working Alliance Inventory, Therapist Form (WAI-T)
timeFrame: Immediately after the end of first three psychotherapy sessions.
measure: Assistance to sessions
timeFrame: Immediately after the end of first three psychotherapy sessions.
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: CEMERA, Faculty of Medicine, Universidad de Chile
state: Region Metropolitana
Study officials:
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