Efficacy of a Transdiagnostic Online Prevention Approach in Adolescents (EMPATIA)

Study Overview
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Brief Summary
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The goal of this randomized controlled clinical trial is to investigate the efficacy of the internet-delivered intervention EMPATIA on general psychopathology of adolescents with subclinical symptoms compared to a Care As Usual (CAU) control group. The primary objective is to: investigate the efficacy of the internet-delivered intervention on general psychopathology of adolescents with subclinical symptoms compared to CAU. secondary objectives include: clinician-rated interviews and self-report questionnaires on the level of social and role functioning, time until onset of a mental disorder and service use. Furthermore, changes in subclinical symptoms, transdiagnostic mechanisms and therapeutic as well as safety measures are assessed by online self-reports Participants will use the internet-delivered intervention EMPATIA during eight weeks. Researchers will compare intervention group to a Care As Usual (CAU) group to investigate the efficacy of the internet-delivered intervention EMPATIA on general psychopathology.

Detailed Description
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The overall objective of this study is to develop and evaluate an internet-delivered indicated prevention program for adolescents with subclinical symptoms designed to target transdiagnostic mechanisms of change. The internet-delivered program will be evaluated in a RCT compared to Care As Usual (CAU) including a 1-year follow-up period. The online program EMPATIA aims to strengthen the well-being and mental health of young people in the long term. For example, in this program, young people learn, among other things, how to better deal with worries, stress, low self-confidence, conflicts with other people, or even unpleasant feelings such as anger, fear, or sadness. These are skills that are known to be helpful for the further development of all adolescents and make them more resilient to stress. In this study, the investigators want to investigate whether the program is helpful, how it works, and which adolescents profit most. For the study, 152 adolescents from Switzerland are asked to participate in the EMPATIA-program online. In order to study the effectiveness scientifically, all adolescents will be randomly divided into two groups, so the differences can be compared. One group will get access to the EMPATIA-program already at the beginning, the other group after 12 months. The contents of the EMPATIA-Program are evidence-based and well-established cognitive-behavioural interventions targeting transdiagnostic mechanisms that have been repeatedly identified to underlie several mental disorders in adolescents: behavioral avoidance, repetitive negative thinking including rumination, worry and intolerance of uncertainty, emotion regulation, self-critical perfectionism and rejection sensitivity. The program consists of 8 modules. It is recommended to complete one module every week with each module lasting about 60 minutes and to make use of additional examples, exercises for everyday life and diaries as often as possible. Furthermore, age- and gender specific topics and main testimonials are offered and can be selected by each participant. The intervention allows tailoring contents through topics that can be additionally selected, such as interpersonal conflicts, self-esteem, and social support and additional examples (e.g., if the predominant emotion experienced is anger vs. sadness). Information will generally be presented via short video-clips, examples from testimonials, audio files, interactive elements, and cartoons instead of text-based parts. At the end of the modules, there is a short quiz that allows participants to review and solidify what they have learned. Participants will be guided (via program integrated chat function) throughout the intervention by e-coaches who are advanced master-students in Clinical Child and Adolescent Psychology.

Official Title
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Randomized Controlled Trial on the Efficacy of a Transdiagnostic Online Prevention Approach in Adolescents (EMPATIA)

Conditions
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Mental Health Issue, Transdiagnostic Mechanisms, Adolescent Psychology, Prevention, Online Intervention, Psychological Intervention, Mental Disorder in Adolescence, Subclinical

Intervention / Treatment
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* Device: EMPATIA 1


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed Consent signed by the subject (if the participant is ≥ 14 years) or signed by the legal guardians (if the participant is 12 or 13 years old). Subjects are between 12 and 18 years old. Subjects experience at least mild self-reported symptoms by scoring above the cut-off in at least one of the respective screening-instruments as assessed at the 12-month follow-up of the EMERGE- study. Subjects have access to the internet and a smart phone, tablet or personal computer. Subjects have sufficient knowledge of German. Exclusion Criteria: Current or lifetime diagnosis according to the Diagnostic Interview for Mental Disorders for Children and Adolescents (Kinder-DIPS, Margraf et al., 2017; Schneider et al., 2017) at baseline. Score of '3' on the suicide item of the PHQ-A (Johnson et al., 2002) or active suicidal plans in the diagnostic telephone interview (Kinder- DIPS, Margraf et al., 2017; Schneider et al., 2017) at baseline.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The present study is a monocentric, two-arm, single-blinded, randomized controlled trial with CAU as control condition.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EMPATIA<br>Participants in this group will access the online prevention program EMPATIA as a self-help online program during eight weeks. | Device: EMPATIA 1<br>* The internet-program EMPATIA is hosted on a secure website https://selfhelp.psy.unibe.ch run by the Faculty of Human Sciences and is accessible from any regular internet browser. The software is not CE-marked as it has been developed for research purposes only. EMPATIA consists of 8 sessions and 1 booster session 3 weeks after the last session. It targets transdiagnostic mechanisms that have been identified in several mental disorders in adolescents: behavioral avoidance, repetitive negative thinking including intolerance of uncertainty, emotion, self-critical perfectionism and rejection sensitivity. The contents of EMPATIA are evidence-based and well-established cognitive-behavioral interventions dedicated to the respective transdiagnostic mechanism. The self-help program consists of psychoeducation, cognitive restructuring, relaxation and acceptance-based interventions, exposure and behavioral experiments and behavioral activation as treatment components.<br>|
| No Intervention: Care As Usual<br>Participants in this group will gain access to the online prevention program EMPATIA after 12 months. All other kinds of interventions during participation are allowed and will be recorded using the Client Sociodemographic and Service Receipt Inventory | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of self-reported general psychopathology | Assessed by the Strength and Difficulties Questionnaire, self-report (SDQ-s; Becker et al., 2018). 25 Items with higher scores indicating higher level of self-reported general psychopathology. | Baseline | 
| Level of self-reported general psychopathology | Assessed by the Strength and Difficulties Questionnaire, self-report (SDQ-s; Becker et al., 2018). 25 Items with higher scores indicating higher level of self-reported general psychopathology. | Month 2 | 
| Level of self-reported general psychopathology | Assessed by the Strength and Difficulties Questionnaire, self-report (SDQ-s; Becker et al., 2018). 25 Items with higher scores indicating higher level of self-reported general psychopathology. | Month 6 | 
| Level of self-reported general psychopathology | Assessed by the Strength and Difficulties Questionnaire, self-report (SDQ-s; Becker et al., 2018). 25 Items with higher scores indicating higher level of self-reported general psychopathology. | Month 9 | 
| Level of self-reported general psychopathology | Assessed by the Strength and Difficulties Questionnaire, self-report (SDQ-s; Becker et al., 2018). 25 Items with higher scores indicating higher level of self-reported general psychopathology. | Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of social functioning | Assessed with a structured interview (Global Functioning Social; GFsocial; Cornblatt et al., 2007). Scores range from 1 to 10 with higher scores indicating higher social functioning. | Baseline and month 12 | 
| Level of role functioning | Assessed with a structured interview (Global Functioning Role; GFrole; Cornblatt et al., 2007). Scores range from 1 to 10 with higher scores indicating higher role functioning. | Baseline and month 12 | 
| Time until onset of a mental disorder | Assessed with the Kinder-DIPS (Diagnostic Interview for Mental Disorders in Children and Adolescents; Schneider, Pflug, In-Albon, & Margraf, 2017) | Baseline and month 12 | 
| Service Use | Assessed with the German version of the Client Sociodemographic and Service Receipt Inventory (CSSRI-EU; Chisholm et al., 2000; Roick et al., 2001). | Month 12 | 
| Depression | The Patient Health Questionnaire-9 for Adolescents (PHQ-A; Johnson et al., 2002) will be used to assess depressive symptoms. This self-report questionnaire consists of 9 items and higher scores indicate higher depressive symptoms. | Baseline, Month 2, 6, 9 and 12 | 
| Hypomania/bipolar symptoms (ASRM; Altman et al., 1997) | The Altman Self-Rating Mania Scale (ASRM) will be used to assess hypomania/bipolar symptoms. It is a 5-item Likert scale in which manic symptoms, corresponding to diagnostic criteria for mania, are rated from 0 to 4 according to increasing severity. | Baseline, Month 2, 6, 9 and 12 | 
| Anxiety (GAD-7; Löwe et al., 2008) | The GAD-7 will be used to measure general anxiety symptoms with 7 items. Higher scores indicate higher levels of anxiety. | Baseline, Month 2, 6, 9 and 12 | 
| Obsessive-compulsive symptoms (SOCS; Piqueras et al., 2015) | The Short Obsessive-Compulsive Disorder Screener (SOCS), a 6 item screening instrument, will be used to assess obsessive-compulsive symptoms. | Baseline, Month 2, 6, 9 and 12 | 
| Psychotic-like experiences (CAPE-P15; Capra et al., 2013). | The 15 item self-report questionnaire CAPE-P15 (Capra et al., 2013) assesses three domains: paranoid ideation, bizarre experiences, and perceptual anomalies. Scores can range from 15 to 75. Higher scores indicate higher severity of psychotic-like experiences. | Baseline, Month 2, 6, 9 and 12 | 
| Alcohol/Substance abuse (CRAFFTd; Tossman et al., 2009) | The CRAFFTd (Tossman et al., 2009) is a one-dimensional screening tool consisting of 6 questions. It will be used to screen for problematic substance consumption in adolescents. Higher scores indicate greater problematic substance consumption. | Baseline, Month 2, 6, 9 and 12 | 
| Eating behavior (ChEDE-Q8; Kliem et al., 2016) | The Child Eating Disorder Examination-Questionnaire (ChEDE-Q8) used in this study is an 8 item self-report scale to assess specific eating disorder psychopathology. | Baseline, Month 2, 6, 9 and 12 | 
| Conduct disorder (SDQ-s; Becker et al., 2018) | The subscale of the Strengths and Difficulties Questionnaire (SDQ-s; Becker et al., 2018) will be used to assess subclinical conduct problems. 5 items, higher scores indicate higher severity of conduct problems. | Baseline, Month 2, 6, 9 and 12 | 
| Non-suicidal self-injurious behavior | (Kinder-DIPS, Additional-Module NSSV; Margraf et al., 2017; Schneider et al., 2017). The suggested 7 questions by Margraf et al. (2017) and Schneider et al. (2017) will be assessed via self-report. Non-suicidal self-injurious behavior in the past year on five or more separate occasions are considered as subclinical. | Baseline, Month 2, 6, 9 and 12 | 
| Somatic symptoms (SSS8; Gierk et al., 2014) | The Somatic Symptom Scale (SSS-8) with 8-item will be used for the assessment of somatic symptom burden. Higher scores indicate higher somatic symptom burden. | Baseline, Month 2, 6, 9 and 12 | 
| Current stress level (PSS-4; Herrero & Meneses, 2006) | Perceived Stress Scale to assess current levels of stress (PSS-4), 4-item version with responses scored on a 1- to 5-point scale. | Baseline, Month 2, 6, 9 and 12 | 
| Adjustment to daily life (WSAS-Y; Jassi et al., 2020) | The WSAS-Y (Work and Social Adjustment Scale-Youth) consists of five items that are rated on a 9-point Likert scale, generating a global score ranging from 0 to 40 (Jassi et al., 2020). | Baseline, Month 2, 6, 9 and 12 | 
| Behavioral avoidance (CEASE-A; Fairholm & Ehrenreich, 2008) | The Checklist of Avoidance Strategy Engagement for Adolescents (CEASE-A) is a psychometrically sound measure of avoidance (Kennedy, 2015). The 29-item checklist assesses frequency of engagement in avoidance behaviors to manage or avoid feelings of anxiety, anger, fear, or sadness on a 5-point Likert-type scale. | Baseline, Month 2, 6, 9 and 12 | 
| Self-perfectionism (F-MPS-B; Burgess et al., 2016) | The Frost Multi-Dimensional Perfectionism Scale-Brief (F-MPS-B; Burgess et al. 2016) is a brief 8-item version of the original F-MPS (35-items) (Frost et al. 1990). Items are rated on a 5-point Likert type scale with higher scores indicating greater perfectionism. | Baseline, Month 2, 6, 9 and 12 | 
| Repetitive negative thinking (RTQ-10; McEvoy et al., 2017) | The Repetitive Thinking Questionnaire (RTQ-10) is a 10-item scale to measure the common transdiagnostic factor repetitive negative thinking. Items are rated on a 5-point scale. | Baseline, Month 2, 6, 9 and 12 | 
| Emotion regulation (DERS-16; Bjureberg et al., 2016) | The Difficulties in Emotion Regulation Scale (DERS-16) is a 16-item self- report measure of emotion regulation difficulties (Bjureberg et al., 2016). | Baseline, Month 2, 6, 9 and 12 | 
| Intolerance of Uncertainty (IUS-12; Carleton et al., 2012) | The Intolerance of Uncertainty Scale is a 12-item short-form of the original 27-item Intolerance of Uncertainty Scale (Freeston et al., 1994). Items are scored on a 5-point Likert scale ranging from 1 to 5. | Baseline, Month 2, 6, 9 and 12 | 
| Rejection sensitivity (C-RSQ; Downey et al., 2013) | The Children's Rejection Sensitivity Questionnaire (C-RSQ; Downey et al., 1998) assesses the rejection sensitivity through 6 hypothetical interpersonal situations with ambiguous outcomes. Participants indicate on a 6-point Likert scale whether they would be nervous about the situation, how angry they would be about the situation, and what their outcome expectancy is. | Baseline, Month 2, 6, 9 and 12 | 
| Satisfaction with the intervention (ZUF-8; Schmidt et al., 1989) | The ZUF-8 is a questionnaire with 8 items for the global, one-dimensional assessment of patient satisfaction (Schmidt et al., 1989). | Week 8 | 
| Adherence to the online-intervention | Assessed within the online-intervention. Indicator of adherence: time spent in program. | During the eight-week online-intervention | 
| Adherence | Assessed within the online-intervention. Indicator of adherence: number of clicks. | During the eight-week online-intervention | 
| Adherence | Assessed within the online-intervention. Indicator of adherence: number of modules completed. | During the eight-week online-intervention | 
| Adherence | Assessed within the online-intervention. Indicator of adherence: number of exercises completed. | During the eight-week online-intervention | 
| Negative Intervention Effects (INEP; Ladwig, Rief & Nestoriuc, 2014) | Negative effects of the intervention will be assessed using a version of the Inventory for the Assessment of Negative Effects in Psychotherapy (Kinder-INEP; Bieda et al., 2018; INEP; Ladwig et al., 2014) adapted for online interventions and for children and adolescents. 12 Items. | Week 8 | 
| Working Alliance (WAI-CA; Figueiredo, 2016) | The Working Alliance Inventory for guided Internet Interventions (WAI-I; Gómez Penedo et al., 2020) is a self-report questionnaire that measures therapeutic alliance in online interventions with therapeutic support. Working Alliance Inventory for Children and Adolescents (WAI-CA) consists of 12 items and has good psychometric properties (Gómez Penedo et al., 2020). | Week 2, 4, 6, 8 | 
| Therapy Motivation (MYTS; Breda & Riemer, 2012) | The Motivation for Youth's Treatment Scale (MYTS; Breda & Riemer, 2012) measures youth's motivation for therapy through a self-report questionnaire. The MYTS is a psychometrically based scale consisting of 8 items. Responses are rated on a 5-point likert scale. Higher ratings indicate higher motivation. | Baseline, Week 2, 4, 6, 8 | 
| Acute suicidality | Assessed by the Kinder-DIPS interview (Margraf et al., 2017; Schneider et al., 2017). | Baseline, Month 12 | 
| Acute suicidality | Suicidality will throughout the study be evaluated by the item 9 of the Patient Health Questionnaire-9 for Adolescents (i.e., PHQ-A; Johnson et al., 2002). With a score 3 as the highest score. | Baseline, Week 2, 4, 6, Month 2, 6, 9, 12 |