Evaluating the feasibility and exploring the efficacy of an emotion-based approach-avoidance modification training (eAAMT) in the context of perceived stress in an adult sample - protocol of a parallel randomized controlled pilot study

Abstract

Background: Stress levels and thus the risk of developing related physical and mental health conditions are rising worldwide. Dysfunctional beliefs contribute to the development of stress. Potentially, such beliefs can be modified with approach-avoidance modification trainings (AAMT). As previous research indicates that effects of AAMTs are small, there is a need for innovative ways of increasing the efficacy of these interventions. For this purpose, we aim to evaluate the feasibility of the intervention and study design and explore the efficacy of an innovative emotion-based AAMT version (eAAMT) that uses the display of emotions to move stress-inducing beliefs away from and draw stress-reducing beliefs towards oneself.

Methods: We will conduct a parallel randomized controlled pilot study at the Friedrich-Alexander-Universität Erlangen-Nürnberg, Germany. Individuals with elevated stress levels will be randomized to one of eight study conditions (n = 10 per condition) - one of six variants of the eAAMT, an active control intervention (swipe-based AAMT), or an inactive control condition. Participants in the intervention groups will engage in four sessions of 20-30 min (e)AAMT training on consecutive days. Participants in the inactive control condition will complete the assessments via an online tool. Non-blinded assessments will be taken directly before and after the training and 1 week after training completion. The primary outcome will be perceived stress. Secondary outcomes will be dysfunctional beliefs, symptoms of depression, emotion regulation skills, and physiological stress measures. We will compute effect sizes and conduct mixed ANOVAs to explore differences in change in outcomes between the eAAMT and control conditions.

Discussion: The study will provide valuable information to improve the intervention and study design. Moreover, if shown to be effective, the approach can be used as an automated smartphone-based intervention. Future research needs to identify target groups benefitting from this intervention utilized either as stand-alone treatment or an add-on intervention that is combined with other evidence-based treatments.

Trial registration: The trial has been registered in the German Clinical Trials Register (Deutsches Register Klinischer Studien; DRKS00023007 ; September 7, 2020).

Keywords: Approach-avoidance modification; Dysfunctional beliefs; Emotion; Parallel randomized controlled pilot trial; Perceived stress; Smartphone-based intervention.

Fig. 1

Study procedure. Note: PSS-10, Perceived Stress Scale 10; E, emotion; d, day; w, week. ^aAll unpleasant emotions (i.e., disgust, anxiety, sadness, and anger) are used to avoid dysfunctional beliefs. The approach-avoidance response ratio is 1:1. ^bAll unpleasant emotions are used to avoid dysfunctional beliefs, but the approach-avoidance response ratio is 4:1

Fig. 2

Exemplary trial flow