The FACE Self-help App for Fostering Resilience
- Conditions
- Adverse Childhood Experiences
- Interventions
- Device: FACE self-help App
- Registration Number
- NCT05824182
- Lead Sponsor
- Jeannette Brodbeck
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 350
- Self-reported ACEs
- An informed consent
- The possession of a smartphone
- Mastery of the German language.
- Age between 18 and 25
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Group FACE self-help App Intervention group: FACE self-help app with guidance
- Primary Outcome Measures
Name Time Method Resilience at week 13, t2 (post-measurement) 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.
- Secondary Outcome Measures
Name Time Method Well-being at week 13, t2 (post-measurement) 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.
Self-Esteem at week 13, t2 (post-measurement) 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.
Stability of decrease in fear of negative evaluation at week 24, t4 (follow-up) 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.
Stability of decrease in social avoidance at week 24, t4 (follow-up) 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.
Emotion Regulation at week 13, t2 (post-measurement) 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.
Fear of Negative Evaluation at week 13, t2 (post-measurement) 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.
Social Avoidance at week 13, t2 (post-measurement) 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.
Problem-Solving at week 13, t2 (post-measurement) 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.
Stability of improvement in emotion regulation at week 24, t4 (follow-up) 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.
Stability of improvement in problem-solving at week 24, t4 (follow-up) 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.
Stability of improvement in self-esteem at week 24, t4 (follow-up) 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.
Stability of improvement in well-being at week 24, t4 (follow-up) 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.
Stability of improvement in resilience at week 24, t4 (follow-up) 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.
Trial Locations
- Locations (1)
University of Applied Sciences and Arts Northwestern Switzerland
🇨🇭Olten, Solothurn, Switzerland