JMIR Publications

ABSTRACT

Background:

Rumination is a transdiagnostic process present in several psychological disorders, involving repetitive negative thinking which individuals may perceive to be difficult to control. While the roles of numerous mechanisms underpinning rumination have been supported, experiential avoidance (EA) continues to lack empirical backing, despite a strong theoretical basis, in part due to difficulties in examining EA in an ecologically valid context. One promising means to addressing this challenge is through the reduction of EA using digital therapeutics (DTx) and ecological momentary intervention (EMI), and assessing any consequent reduction in rumination’s deleterious outcomes.

Objective:

This paper describes the protocol for a randomised-controlled trial using a novel mHealth EMI to address experiential avoidance in the context of rumination. The application was developed in a multidisciplinary team utilising feedback from potential end users.

Methods:

Consenting individuals (total end targetN=60) meeting the inclusion criteria for the trial (self-reporting problems with repetitive negative thinking) will be randomly allocated to one of four conditions (intervention with therapist support and daily sampling; intervention without support and with daily sampling; partial intervention (emotion validation EMI only) and daily sampling; control: daily sampling only). The intervention contains a series of modules delivered over four weeks, with assessments conducted pre- and post-intervention, then at one-month follow-up (plus a further three-month follow-up for intervention participants). Data will be collected both using online self-report assessments and through the app itself. The potential of the EMI to modify the maladaptive feature of repetitive negative thinking using mixed-design ANOVA, and the links between avoidance:mood and rumination:mood in terms of the moderating effect of trial condition using multi-level models will be assessed as primary outcomes. Secondary outcomes include effects of a supporting therapist on post-intervention outcomes in intervention groups and time spent using the application as a measure of engagement (using mixed-design ANCOVA). Compliance will be defined as completing both of the first two weeks of intervention content in full and five out of the six exercises from weeks three and four. Additionally, we will control for the amount of time spent in the application and the length of response content to open-questions.

Results:

Recruitment and enrolment for the trial is expected to begin 09/2024, and is expected to be completed by 10/2024. Data collection will conclude once the target sample size for each of the four conditions has been met. The main results of the trial are expected to be submitted for publication in 02/2025.

Conclusions:

Outcomes of this trial will not only provide insight into the clinical capabilities of the application and its usability and acceptability in real-world contexts, but will also provide valuable theoretical insight into the role of experiential avoidance in maladaptive rumination. Clinical Trial: ClinicalTrials.gov registration [blinded for review]