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The FACE Self-help App for Fostering Resilience

J

Jeannette Brodbeck

Status

Enrolling

Conditions

Adverse Childhood Experiences

Treatments

Device: FACE self-help App

Study type

Interventional

Funder types

Other

Identifiers

NCT05824182
SNF_197731_B

Details and patient eligibility

About

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).

Full 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.

Enrollment

350 estimated patients

Sex

All

Ages

18 to 25 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

350 participants in 2 patient groups

Intervention Group
Experimental group
Description:
Intervention group: FACE self-help app with guidance
Treatment:
Device: FACE self-help App
control group
No Intervention group
Description:
Waiting list control group with questionnaires and EMA

Trial contacts and locations

1

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Central trial contact

Jeannette Brodbeck, Professor

Data sourced from clinicaltrials.gov

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