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Adverse Childhood ExperiencesNCT05824182

The FACE Self-help App for Fostering Resilience

A study testing FACE self-help App in people with Adverse Childhood Experiences, run by Jeannette Brodbeck at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 25 yearsHealthy volunteers can take part
Conditions the study is for
Adverse Childhood Experiences
What is being tested?
FACE self-help App
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
167 participants
Where
1 siteSwitzerland
Study dates
31 May 2023to 23 Jan 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 25 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Self-reported ACEs
  • An informed consent
  • The possession of a smartphone
  • Mastery of the German language.
  • Age between 18 and 25

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site
  • University of Applied Sciences and Arts Northwestern Switzerland

    Olten, Canton of Solothurn, 4600

Other trials in Switzerland

About this study

Official title: Fostering Resilience and Well-being in Young Adults With a History of Adverse Childhood Experiences - the FACE Self-help App

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).

Read the 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

  1. the differential efficacy of the self- and emotion regulation and the social skills and social information processing component
  2. 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.

Being tested
FACE self-help App
Keywords
Adverse Childhood Experiences, Psychosocial Functioning, Emotion Regulation, Social Information Processing, Online self-help
Medical subject headings
Emotional Regulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FACE self-help AppDevice

    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.

Study groups in NCT05824182
Study groupRoleWhat they receive
Intervention GroupExperimentalIntervention group: FACE self-help app with guidance
Receives: Device: FACE self-help App
control groupNo interventionWaiting list control group with questionnaires and EMA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Resilience

    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.

    Measured: at week 13, t2 (post-measurement)

Secondary outcomes (13)
  1. Well-being

    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.

    Measured: at week 13, t2 (post-measurement)

  2. Emotion Regulation

    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.

    Measured: at week 13, t2 (post-measurement)

  3. Fear of Negative Evaluation

    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.

    Measured: at week 13, t2 (post-measurement)

  4. Social Avoidance

    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.

    Measured: at week 13, t2 (post-measurement)

  5. Problem-Solving

    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.

    Measured: at week 13, t2 (post-measurement)

  6. Self-Esteem

    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.

    Measured: at week 13, t2 (post-measurement)

  7. Stability of improvement in well-being

    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.

    Measured: at week 24, t4 (follow-up)

  8. Stability of improvement in emotion regulation

    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.

    Measured: at week 24, t4 (follow-up)

  9. Stability of decrease in fear of negative evaluation

    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.

    Measured: at week 24, t4 (follow-up)

  10. Stability of decrease in social avoidance

    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.

    Measured: at week 24, t4 (follow-up)

  11. Stability of improvement in problem-solving

    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.

    Measured: at week 24, t4 (follow-up)

  12. Stability of improvement in self-esteem

    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.

    Measured: at week 24, t4 (follow-up)

  13. Stability of improvement in resilience

    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.

    Measured: at week 24, t4 (follow-up)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2023
  2. Study start31 May 2023
  3. Primary completion23 Jan 2025
  4. Study completion23 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
167 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05824182
Sponsor's protocol ID
SNF_197731_B
Status last verified
Dec 2025
First submitted
23 Mar 2023
Last updated
24 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data will be available on request to interested researchers

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.

    PubMed 12964174
  • 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.

    PubMed 22021660
  • 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.

    PubMed 26590238
  • 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.

    PubMed 18042300
  • 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.

  • 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.

    PubMed 5810590
  • 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.

    PubMed 21988094
  • 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.

Questions about this trial

What is this clinical trial studying?

A study testing FACE self-help App in people with Adverse Childhood Experiences, run by Jeannette Brodbeck at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Resilience (time frame: at week 13, t2 (post-measurement)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05824182, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.

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