Ignite Creation Date:
2024-05-06 @ 6:53 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05824182
Status:
RECRUITING
Last Update Posted:
2023-10-11
First Post:
2023-03-23
Brief Title:
The FACE Self-help App for Fostering Resilience
Sponsor:
Jeannette Brodbeck
Organization:
University of Applied Sciences and Arts Northwestern Switzerland
Study Overview
Official Title:
Fostering Resilience and Well-being in Young Adults With a History of Adverse Childhood Experiences - the FACE Self-help App
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None