Clinical trial NCT05824182: The FACE Self-help App for Fostering Resilience
Official title: Fostering Resilience and Well-being in Young Adults With a History of Adverse Childhood Experiences - the FACE Self-help App
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Adverse Childhood Experiences
Keywords: Adverse Childhood Experiences
Psychosocial Functioning
Emotion Regulation
Social Information Processing
Online self-help
Lead sponsor: University of Applied Sciences and Arts Northwestern Switzerland
Sponsor class: OTHER
Collaborators: name: University of Bern
First posted: 2023-04-21
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Resilience
timeFrame: at week 13, t2 (post-measurement)
Secondary outcomes:
measure: Well-being
timeFrame: at week 13, t2 (post-measurement)
measure: Emotion Regulation
timeFrame: at week 13, t2 (post-measurement)
measure: Fear of Negative Evaluation
timeFrame: at week 13, t2 (post-measurement)
measure: Social Avoidance
timeFrame: at week 13, t2 (post-measurement)
measure: Problem-Solving
timeFrame: at week 13, t2 (post-measurement)
measure: Self-Esteem
timeFrame: at week 13, t2 (post-measurement)
measure: Stability of improvement in well-being
timeFrame: at week 24, t4 (follow-up)
measure: Stability of improvement in emotion regulation
timeFrame: at week 24, t4 (follow-up)
measure: Stability of decrease in fear of negative evaluation
timeFrame: at week 24, t4 (follow-up)
measure: Stability of decrease in social avoidance
timeFrame: at week 24, t4 (follow-up)
measure: Stability of improvement in problem-solving
timeFrame: at week 24, t4 (follow-up)
measure: Stability of improvement in self-esteem
timeFrame: at week 24, t4 (follow-up)
measure: Stability of improvement in resilience
timeFrame: at week 24, t4 (follow-up)
Other outcomes:
measure: Participant satisfaction
timeFrame: at week 13, t2 (post-measurement)
measure: Momentary affect
timeFrame: three one week periods with 6 measurements a day (t0, t1, t2)
measure: Momentary coping
timeFrame: three one week periods with 6 measurements a day (t0, t1, t2)
measure: Momentary burden
timeFrame: three one week periods with 6 measurements a day (t0, t1, t2)
measure: Momentary social interactions
timeFrame: three one week periods with 6 measurements a day (t0, t1, t2)
Locations:
city: Olten
country: Switzerland
facility: University of Applied Sciences and Arts Northwestern Switzerland
state: Solothurn
Study officials:
affiliation: University of Applied Sciences and Arts Northwestern Switzerland
name: Jeannette Brodbeck, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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
citation: 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.
citation: 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
citation: 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
citation: 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.
citation: PROMIS. (2022). https://www.healthmeasures.net/explore-measurement-systems/promis
citation: Rosenberg, M. (1965). Society and the adolescent self-image. Princeton university press.
citation: 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
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Röthlin, P., Holtforth, M. G., Bergomi, C., Berking, M., Ottenbreit, N. D., & Caspar, F. (2010). Vermeidung und depression. Diagnostica.