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

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

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.

Study Overview

• Status: Terminated
• Conditions: Depressive Symptoms
• Intervention / Treatment: Behavioral: EMA prompting for patients; Behavioral: PDF Reports for therapists

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Chile
  • Region Metropolitana
    • Santiago, Region Metropolitana, Chile, 8380455
      • CEMERA, Faculty of Medicine, Universidad de Chile

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 24 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; 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; 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.; Behavioral: 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.
Active Comparator: Control group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Collaborators and Investigators

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

Publications and helpful links

General Publications

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Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2020
• Primary Completion (Actual): November 24, 2021
• Study Completion (Actual): November 30, 2021

Study Registration Dates

• First Submitted: March 30, 2021
• First Submitted That Met QC Criteria: April 1, 2021
• First Posted (Actual): April 5, 2021

Study Record Updates

• Last Update Posted (Actual): May 23, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: depression; adherence; youth; Ecological Momentary Assessment; therapeutic alliance; e-mental Health; e-Health
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 030-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No