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

Depressive Symptoms Clinical Trial

Official title:

Development and Evaluation of an Ecological Momentary Assessment (EMA) Baseline Screening System for Therapists Who Treat Youths With Depressive Symptoms

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04830527
• Other study ID #: 030-2020
• Status: Terminated
• Phase: N/A
• Start date: November 24, 2020
• Est. completion date: November 30, 2021

Study information

• Verified date: May 2022
• Source: University of Chile
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: November 30, 2021
• Est. primary completion date: November 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 24 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Symptoms

Intervention

Behavioral:
• EMA prompting for patients
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.
• PDF Reports for therapists
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.

Locations

Country	Name	City	State
Chile	CEMERA, Faculty of Medicine, Universidad de Chile	Santiago	Region Metropolitana

Sponsors (4)

Lead Sponsor	Collaborator
Vania Martínez-Nahuel	ANID - Millennium Science Initiative Program - ICS13_005 Millennium Institute for Research in Depression and Personality (MIDAP), Santiago, Chile, ANID - Millennium Science Initiative Program - NCS17_03 Millennium Nucleus to Improve the Mental Health of Adolescents and Youths (Imhay), Santiago, Chile, Center for Psychotherapy Research, University Hospital Heidelberg, Heidelberg, Germany

Country where clinical trial is conducted

Chile, 

References & Publications (32)

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* Note: There are 32 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Working Alliance Inventory, Therapist Form (WAI-T)	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	Assistance to sessions	Assistance to sessions will be registered by therapists as a measurement of initial adherence.	Immediately after the end of first three psychotherapy sessions.