- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05824182
The FACE Self-help App for Fostering Resilience
Fostering Resilience and Well-being in Young Adults With a History of Adverse Childhood Experiences - the FACE Self-help App
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The FACE self-help app is an online intervention for young adults with Adverse Childhood Experiences (ACEs). It was developed based on well-established cognitive-behavioural therapy principles. The self-help app contains two components, one targeting emotion regulation (ER), the other social information processing (SIP).
The goal of the present study is to evaluate the efficacy of the FACE self-help app, which aims to foster resilience and improve well-being by enhancing emotion regulation, social skills and minimizing biases in social information processing.
The primary objective is to examine the efficacy of the FACE self-help app for improving resilience and well-being in young adults with a history of ACEs compared to a waiting list control group and to examine the stability of a possible effect.
Secondary objectives are to test
- the differential efficacy of the self- and emotion regulation and the social skills and social information processing component
- the effects of the FACE self-help app on real life data in affective states, social interactions, the use of coping strategies and state resilience.
To assess real life data, additionally to questionnaires (Q), an ecological momentary assessment (EMA) will be conducted in three one-week episodes, with 6 daily assessments each.
Procedures: After giving informed consent, participants will receive the online questionnaires and one week of EMA (t0, week 1). Then, participants will be randomly assigned to either the intervention or waiting list control group. Within the intervention group, participants are randomly assigned to start with the ER or SIP component. After 5 weeks of using the first component of the FACE self-help app, participants fill out the intermediate measure (t1, week 7). After another week of EMA, the next component (ER or SIP) of the self-help app is available for 5 weeks. Subsequently, the post-measurement and the last EMA period start (t2, week 13). This results in a total intervention period of 11 weeks. A follow-up measure will be conducted after another 11 weeks (t4, week 25). Participants will receive online guidance from trained e-coaches.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Canton of Solothurn
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Olten, Canton of Solothurn, Switzerland, 4600
- University of Applied Sciences and Arts Northwestern Switzerland
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Self-reported ACEs
- An informed consent
- The possession of a smartphone
- Mastery of the German language.
- Age between 18 and 25
Exclusion Criteria:
- Inability to follow the procedures of the study, e.g., due to comprehension problems, visual impairment, lack of sufficient motor skills or severe psychological or somatic disorders which require immediate treatment which impedes the continuous work on the self-help programme. These points will be discussed with the participant in the screening telephone call.
- Acute suicidality.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group
Intervention group: FACE self-help app with guidance
|
The FACE self-help app was developed based on well-established non-invasive psychological principles that have been used in other web-based self-help interventions.
The app consists of two component, emotion regulation and social information processing/social skills with four modules each.
Each module includes readings describing scientific knowledge about ACEs and ACEs related topics, as well as exercises to encourage participants to actively reflect on what was learned in the readings and to apply their knowledge and practice skills.
Each module is divided in several submodules that include readings and exercises.
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No Intervention: control group
Waiting list control group with questionnaires and EMA
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Resilience
Time Frame: at week 13, t2 (post-measurement)
|
Resilience will be assessed with the German version (Sarubin et al., 2015) of the Connor-Davidson Resilience Scale (CD-RISC) (Connor & Davidson, 2003).
The scale contains 10 items that are rated on a 5-point scale from 0 - Not true at all to 4 - True nearly all the time.
A higher score indicates more resilience.
|
at week 13, t2 (post-measurement)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Well-being
Time Frame: at week 13, t2 (post-measurement)
|
Well-being will be assessed with the Warwick-Edinburgh Mental Well-being Scale (WEMWBS) (Tennant et al., 2007).
The scale contains 14 items that are rated on a 5-point scale from 1 - never to 5 - always.
A higher score indicates better well-being.
|
at week 13, t2 (post-measurement)
|
|
Emotion Regulation
Time Frame: at week 13, t2 (post-measurement)
|
Self-Efficacy for Managing Emotions will be assessed with the PROMIS Short Form v1.0 - Self-Efficacy for Managing Emotions (PROMIS, 2022).
The scale contains 7 items that are rated on a 5-point scale from 1 - never to 5 - always.
A higher score indicates better emotion regulation skills.
|
at week 13, t2 (post-measurement)
|
|
Fear of Negative Evaluation
Time Frame: at week 13, t2 (post-measurement)
|
Fear of Negative Evaluation will be assessed with the German short version of the fear of Negative Evaluation Scale (SANB-5) (Kemper et al., 2012).
The scale contains 5 items that are rated on a 4-point likert scale from 1 - almost never true to 4- almost always true.
A higher score indicates more fear of negative evaluation.
|
at week 13, t2 (post-measurement)
|
|
Social Avoidance
Time Frame: at week 13, t2 (post-measurement)
|
Social avoidance will be assessed with the subscale social-behavioral avoidance from the German version of the cognitive-behavioral avoidance scale (KBVS) (Röthlin et al., 2010).
The subscale contains 8 items that are rated on a 5-point likert scale from 1 - not at all applicable for me to 5 - absolutely applicable for me.
A higher score indicates more social avoidance.
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at week 13, t2 (post-measurement)
|
|
Problem-Solving
Time Frame: at week 13, t2 (post-measurement)
|
Problem-solving will be assessed with German version (Graf, 2003) of the short form of the Social Problem-Solving Inventory-Revised (SPSI-R) (D'Zurilla et al., 2002).The scale contains 25 items that are rated on a 5-point scale from 0 - not at all true to 4 - extremely true.
The scale contains 5 subscales: positive problem orientation, negative problem orientation, rational problem-solving, impulsive style, avoidance style.
A higher score indicates a higher orientation on each subscale.
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at week 13, t2 (post-measurement)
|
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Self-Esteem
Time Frame: at week 13, t2 (post-measurement)
|
Self-esteem will be assessed with the German version (Collani & Herzberg, 2003) of the Rosenberg Self-Esteem Scale (Rosenberg, 1965).
The scale contains 10 items that are rated on a 4-point scale from 1 - not at all true to 4 - extremely true.
A higher score indicates more self-esteem.
|
at week 13, t2 (post-measurement)
|
|
Stability of improvement in well-being
Time Frame: at week 24, t4 (follow-up)
|
Well-being will be assessed with the Warwick-Edinburgh Mental Well-being Scale (WEMWBS) (Tennant et al., 2007).
The scale contains 14 items that are rated on a 5-point scale from 1 - never to 4 - always.
A higher score indicates better well-being.
|
at week 24, t4 (follow-up)
|
|
Stability of improvement in emotion regulation
Time Frame: at week 24, t4 (follow-up)
|
Self-Efficacy for Managing Emotions will be assessed with the PROMIS Short Form v1.0 - Self-Efficacy for Managing Emotions (PROMIS, 2022).
The scale contains 7 items that are rated on a 5-point scale from 1 - never to 5 - always.
A higher score indicates better emotion regulation skills.
|
at week 24, t4 (follow-up)
|
|
Stability of decrease in fear of negative evaluation
Time Frame: at week 24, t4 (follow-up)
|
Fear of Negative Evaluation will be assessed with the German short version of the fear of Negative Evaluation Scale (SANB-5) (Kemper et al., 2012).
The scale contains 5 items that are rated on a 4-point likert scale from 1 - almost never true to 4- almost always true.
A higher score indicates more fear of negative evaluation.
|
at week 24, t4 (follow-up)
|
|
Stability of decrease in social avoidance
Time Frame: at week 24, t4 (follow-up)
|
Social avoidance will be assessed with the subscale social-behavioral avoidance from the German version of the cognitive-behavioral avoidance scale (KBVS) (Röthlin et al., 2010).
The subscale contains 8 items that are rated on a 5-point likert scale from 1 - not at all applicable for me to 5 - absolutely applicable for me.
A higher score indicates more social avoidance.
|
at week 24, t4 (follow-up)
|
|
Stability of improvement in problem-solving
Time Frame: at week 24, t4 (follow-up)
|
Problem-solving will be assessed with German version (Graf, 2003) of the short form of the Social Problem-Solving Inventory-Revised (SPSI-R) (D'Zurilla et al., 2002).
The scale contains 25 items that are rated on a 5-point scale from 0 - not at all true to 4 - extremely true.
The scale contains 5 subscales: positive problem orientation, negative problem orientation, rational problem-solving, impulsive style, avoidance style.
A higher score indicates a higher orientation on each subscale.
|
at week 24, t4 (follow-up)
|
|
Stability of improvement in self-esteem
Time Frame: at week 24, t4 (follow-up)
|
Self-esteem will be assessed with the German version (Collani & Herzberg, 2003) of the Rosenberg Self-Esteem Scale (Rosenberg, 1965).
The scale contains 10 items that are rated on a 4-point scale from 1 - not at all true to 4 - extremely true.
A higher score indicates more self-esteem.
|
at week 24, t4 (follow-up)
|
|
Stability of improvement in resilience
Time Frame: at week 24, t4 (follow-up)
|
Resilience will be assessed with the German version (Sarubin et al., 2015) of the Connor-Davidson Resilience Scale (CD-RISC) (Connor & Davidson, 2003).
The scale contains 10 items that are rated on a 5-point scale from 0 - Not true at all to 4 - True nearly all the time.
A higher score indicates more resilience.
|
at week 24, t4 (follow-up)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Participant satisfaction
Time Frame: at week 13, t2 (post-measurement)
|
The ZUF-8 is a self-report measure that explores patients' overall satisfaction with the treatment (Schmidt et al., 1989).
For this study, the instrument was adapted to explore patients' satisfaction with the Internet intervention studied in this trial.
The scale contains eight items that are rated on a 4-point scale from 1 - low satisfaction to 4 - high satisfaction.
A higher score indicates more satisfaction with the online intervention.
The German version of the ZUF-8 showed adequate psychometric properties with good internal consistency, construct validity, and concurrent validity (Schmidt et al., 1989).
|
at week 13, t2 (post-measurement)
|
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Momentary affect
Time Frame: three one week periods with 6 measurements a day (t0, t1, t2)
|
The scale is an abbreviated version of the PANAS following previous research, that used similar EMA items (Oorschot et al., 2013; Wichers et al., 2012).
|
three one week periods with 6 measurements a day (t0, t1, t2)
|
|
Momentary coping
Time Frame: three one week periods with 6 measurements a day (t0, t1, t2)
|
The items of the coping scale were developed by this research team on the basis of previous research (Daros et al., 2019).
They measure different emotion regulation and coping strategies such as reappraisal, avoidance or changing the situation.
|
three one week periods with 6 measurements a day (t0, t1, t2)
|
|
Momentary burden
Time Frame: three one week periods with 6 measurements a day (t0, t1, t2)
|
These items were developed by this research team as an addition to the emotion regulation items based on feedback from a user testing group.
The participants indicate how burdened they feel in different areas.The scale contains 6 items (school/work, family, friends, feelings/thoughts, difficult memories, leisure time) that are rated on a 7-point scale from 0 - not at all to 6 - extremely.
Furthermore, participants can indicate burdens in other areas.
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three one week periods with 6 measurements a day (t0, t1, t2)
|
|
Momentary social interactions
Time Frame: three one week periods with 6 measurements a day (t0, t1, t2)
|
These items were developed by this research team. The Items explore the participants emotional state in the last social situation, for example how happy a person felt in the interaction. First, participants are asked, if they had a social interaction since the last measurement. If participants indicate an interaction, there are 7 follow-up questions about how the participant felt in this interaction. The scale contains 7 items (stressed, well, anxious, understood, irritated, insecure, happy) that are rated on a 7-point scale from 0 - not at all to 6 - extremely. |
three one week periods with 6 measurements a day (t0, t1, t2)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jeannette Brodbeck, Professor, University of Applied Sciences and Arts Northwestern Switzerland
Publications and helpful links
General Publications
- Connor KM, Davidson JR. Development of a new resilience scale: the Connor-Davidson Resilience Scale (CD-RISC). Depress Anxiety. 2003;18(2):76-82. doi: 10.1002/da.10113.
- Tennant R, Hiller L, Fishwick R, Platt S, Joseph S, Weich S, Parkinson J, Secker J, Stewart-Brown S. The Warwick-Edinburgh Mental Well-being Scale (WEMWBS): development and UK validation. Health Qual Life Outcomes. 2007 Nov 27;5:63. doi: 10.1186/1477-7525-5-63.
- Watson D, Friend R. Measurement of social-evaluative anxiety. J Consult Clin Psychol. 1969 Aug;33(4):448-57. doi: 10.1037/h0027806. No abstract available.
- Daros, A. R., Daniel, K. E., Meyer, M. J., Chow, P. I., Barnes, L. E., & Teachman, B. A. (2019). Impact of social anxiety and social context on college students' emotion regulation strategy use: An experience sampling study. Motivation and Emotion, 43(5), 844-855. https://doi.org/10.1007/s11031-019-09773-x
- D'Zurilla, T. J., Nezu, A. M., & Maydeu-Olivares, A. (2002). Social problem-solving inventory-revised: Technical manual. North Tonawanda, NY: Multi-Health Systems, 475.
- Graf, A. (2003). Psychometrische Überprüfung einer deutschsprachigen Übersetzung des SPSI-R. Zeitschrift für Differentielle und Diagnostische Psychologie, 24(4), 277-291. https://doi.org/10.1024/0170-1789.24.4.277
- Grosse Holtforth, M., & Grawe, K. (2003). Der Inkongruenzfragebogen (INK). Zeitschrift für Klinische Psychologie und Psychotherapie, 32(4), 315-323. https://doi.org/10.1026/0084-5345.32.4.315
- Oorschot M, Lataster T, Thewissen V, Lardinois M, Wichers M, van Os J, Delespaul P, Myin-Germeys I. Emotional experience in negative symptoms of schizophrenia--no evidence for a generalized hedonic deficit. Schizophr Bull. 2013 Jan;39(1):217-25. doi: 10.1093/schbul/sbr137. Epub 2011 Oct 20.
- PROMIS. (2022). https://www.healthmeasures.net/explore-measurement-systems/promis
- Rosenberg, M. (1965). Society and the adolescent self-image. Princeton University Press.
- Sarubin, N., Gutt, D., Giegling, I., Bühner, M., Hilbert, S., Krähenmann, O., Wolf, M., Jobst, A., Sabaß, L., Rujescu, D., Falkai, P., & Padberg, F. (2015). Erste Analyse der psychometrischen Eigenschaften und Struktur der deutschsprachigen 10- und 25-Item Version der Connor-Davidson Resilience Scale (CD-RISC). Zeitschrift für Gesundheitspsychologie, 23(3), 112-122. https://doi.org/10.1026/0943-8149/a000142
- Schick M, Schonbucher V, Landolt MA, Schnyder U, Xu W, Maier T, Mohler-Kuo M. Child Maltreatment and Migration: A Population-Based Study Among Immigrant and Native Adolescents in Switzerland. Child Maltreat. 2016 Feb;21(1):3-15. doi: 10.1177/1077559515617019. Epub 2015 Nov 19.
- Vormbrock, F., & Neuser, J. (1983). Konstruktion zweier spezifischer Trait-Fragebogen zur Erfassung von Angst in sozialen Situationen (SANB und SVSS). Diagnostica, 29(2), 165-182.
- Wichers M, Peeters F, Rutten BP, Jacobs N, Derom C, Thiery E, Delespaul P, van Os J. A time-lagged momentary assessment study on daily life physical activity and affect. Health Psychol. 2012 Mar;31(2):135-44. doi: 10.1037/a0025688. Epub 2011 Oct 10.
- Kemper, C. J., Lutz, J., & Neuser, J. (2012). Konstruktion und Validierung einer Kurzform der Skala Angst vor negativer Bewertung (SANB-5). Klinische Diagnostik und Evaluation, 4, 343-360.
- Röthlin, P., Holtforth, M. G., Bergomi, C., Berking, M., Ottenbreit, N. D., & Caspar, F. (2010). Vermeidung und depression. Diagnostica.
- Brodbeck J, Botschi SIR, Vetsch N, Stallmann L, Lochner J, Berger T, Schmidt SJ, Marmet S. Fostering resilience and well-being in emerging adults with adverse childhood experiences: study protocol for a randomized controlled trial to evaluate the FACE self-help app. BMC Psychol. 2024 Feb 19;12(1):84. doi: 10.1186/s40359-024-01560-9.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SNF_197731_B
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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