NCT05824182

Brief 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. The self-help app contains two components, one targeting emotion regulation (ER), the other social information processing (SIP).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
167

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

April 21, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

May 31, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2025

Completed
Last Updated

December 24, 2025

Status Verified

December 1, 2025

Enrollment Period

1.7 years

First QC Date

March 23, 2023

Last Update Submit

December 18, 2025

Conditions

Keywords

Adverse Childhood ExperiencesPsychosocial FunctioningEmotion RegulationSocial Information ProcessingOnline self-help

Outcome Measures

Primary Outcomes (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.

    at week 13, t2 (post-measurement)

Secondary Outcomes (13)

  • Well-being

    at week 13, t2 (post-measurement)

  • Emotion Regulation

    at week 13, t2 (post-measurement)

  • Fear of Negative Evaluation

    at week 13, t2 (post-measurement)

  • Social Avoidance

    at week 13, t2 (post-measurement)

  • Problem-Solving

    at week 13, t2 (post-measurement)

  • +8 more secondary outcomes

Other Outcomes (5)

  • Participant satisfaction

    at week 13, t2 (post-measurement)

  • Momentary affect

    three one week periods with 6 measurements a day (t0, t1, t2)

  • Momentary coping

    three one week periods with 6 measurements a day (t0, t1, t2)

  • +2 more other outcomes

Study Arms (2)

Intervention Group

EXPERIMENTAL

Intervention group: FACE self-help app with guidance

Device: FACE self-help App

control group

NO INTERVENTION

Waiting list control group with questionnaires and EMA

Interventions

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.

Intervention Group

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Applied Sciences and Arts Northwestern Switzerland

Olten, Canton of Solothurn, 4600, Switzerland

Location

Related Publications (17)

  • 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.

    PMID: 12964174BACKGROUND
  • 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

    BACKGROUND
  • 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.

    BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 22021660BACKGROUND
  • PROMIS. (2022). https://www.healthmeasures.net/explore-measurement-systems/promis

    BACKGROUND
  • Rosenberg, M. (1965). Society and the adolescent self-image. Princeton university press.

    BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 26590238BACKGROUND
  • 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.

    PMID: 18042300BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 5810590BACKGROUND
  • 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.

    PMID: 21988094BACKGROUND
  • 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.

    BACKGROUND
  • Röthlin, P., Holtforth, M. G., Bergomi, C., Berking, M., Ottenbreit, N. D., & Caspar, F. (2010). Vermeidung und depression. Diagnostica.

    BACKGROUND
  • 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.

MeSH Terms

Conditions

Emotional Regulation

Condition Hierarchy (Ancestors)

Self-ControlSocial BehaviorBehavior

Study Officials

  • Jeannette Brodbeck, Professor

    University of Applied Sciences and Arts Northwestern Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

March 23, 2023

First Posted

April 21, 2023

Study Start

May 31, 2023

Primary Completion

January 23, 2025

Study Completion

January 23, 2025

Last Updated

December 24, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

De-identified individual participant data will be available on request to interested researchers

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of data collection (2025)
Access Criteria
Access to these data is permitted for scientific purposes on request. A data access agreement will be signed and the source of the data (including the funding agency) needs to be acknowledged.

Locations