RCT Protocol for 'OverThinking': A Mobile EMI for Reducing Experiential Avoidance

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Social Sciences and Humanities, Warsaw

About this trial

The goal of this trial is to examine whether a mobile app intervention for rumination can modify a maladaptive feature of repetitive negative thinking (RNT) - this is understood by the link between daily RNT and well-being, depressive and anxiety symptoms.

The main questions it aims to answer are:

1. If the intervention can modify the maladaptive feature of repetitive negative thinking - the investigators anticipate the link between daily rumination and maladaptive outcomes (poorer wellbeing, higher depressive/anxious symptoms) will be weaker in the intervention groups. 2. By examining (1) above, to confirm the role played by avoidance in repetitive negative thinking. 3. By splitting the intervention condition into two groups (one receiving concurrent support from a therapist, one not), to evaluate if interventions such as these might be enhanced by therapist support. 4. To examine if the impact of the intervention on depressive and anxious symptoms might be mediated by changes in beliefs regarding emotions (e.g. the valuation of negative emotions).

Researchers will compare across four groups to examine the above effects:

(1) intervention condition (therapist support); (2) intervention condition (no therapist support); (3) Partial intervention (daily sampling and emotion valuation questions); (4) Control group (only daily sampling questions).

Participants will:

* Be requested to participate in a four-week intervention, providing daily assessments of depressive and anxiety symptoms, affect, repetitive negative thinking, and rumination outcomes. * Use a mobile application during the intervention period, which has been designed by the research team (intervention groups), or provide daily assessment scores only (control groups). * Be assessed at pre-intervention (all groups), post-intervention (all groups), 1-month follow-up (all groups), and 3-month follow-up (intervention groups only).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Aged below 18 years at the commencement of the trial.

Currently in receipt of any form of psychotherapy.

Currently in receipt of any form of psychiatric medication.

Trial design

Design model

Parallel

Treatments tested in this trial

  • OverThinking

    Behavioral

    OverThinking is a mobile application ecological momentary intervention for iOS and Android, which has been designed for the reduction of experiential avoidance in rumination. The application primarily consists of psychoeducation content and related exercises intended to be delivered over a four-week period. In order to examine the effectiveness of the application during the course of the intervention and to examine user-experiences of using the application for the purpose of rumination intervention, a number of self-report tools are embedded.

Treatment groups

60 Participants
are divided into 4 treatment groups
Group A: Intervention Group 1: Concurrent Therapist SupportExperimental treatment 1 intervention
Group B: Intervention Group 2: No Concurrent Therapist SupportExperimental treatment 1 intervention
Group C: Partial InterventionNo intervention 0 interventions
Group D: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Perseverative thinking as measured by the Perseverative Thinking Questionnaire (PTQ)

The PTQ is a 15-item self-report measure, which assesses the main characteristics of repetitive negative thinking (1: core features - 9 items, 2: unproductiveness - 3 items, 3: capturing mental capacity - 3 items. Responses are recorded on a scale of '0' ('never') to '4' ('almost always').

Time frame
Two months (4-week intervention plus 1-month follow-up)
2

Beliefs about emotions as measured by the Emotion Beliefs Questionnaire EBQ

The EBQ is a 16-item self-report questionnaire intended to measure the controllability of emotions and respondent beliefs about the usefulness of emotions. Respondents answer using a 7-point Likert scale ranging from 1 (totally disagree) to 7 (totally agree), with high scores indicating a belief that emotions are uncontrollable and/or useless.

Time frame
Two months (4-week intervention plus 1-month follow-up)
3

Metacognitive beliefs about rumination using PBRS/NBRS

This is comprised of two sub-scales (positive beliefs: 9-items, negative beliefs: 13-items) measuring metacognitive beliefs of depressive rumination. Respondents rate the extent to which they agree with each of the items using a 4-point Likert-type scale ranging from 1 (do not agree) to 4 (agree very much), with higher scores on each subscale indicating greater positive/negative belief accordingly.

Time frame
Two months (4-week intervention plus 1-month follow-up)
4

Hospital Anxiety and Depression Scale (HADS)

A measure of possible and probable presence of anxiety disorders and depression, comprising seven items for depression and seven items for anxiety. Respondents rate on a scale of 0-3 for each item, with higher total scores for each subdomain (anxiety, depression) indicating greater presence of the disorder. Thresholds are provided for determining the clinical presence of disorder as follows: 0-7 = Normal, 8-10 = Borderline abnormal (borderline case),11-21 = Abnormal (case)

Time frame
Two months (4-week intervention plus 1-month follow-up)

Secondary outcomes

1

Time spent using the application

The application has been designed to record the amount of time a user is active (and in which in-app exercises). This data is stored remotely and securely via Firebase. This data is password protected and access is limited to the individuals on the research team.

Time frame
During the 4-week intervention period and 1-month follow-up period

Other outcomes

1

Ongoing Application Development Feedback (CORTO)

Three items (two quantitative and two qualitative) collected following each in-app exercise, with the aim of providing real-time user-experience data to enable the ongoing development of the app. Items include: 1) Do you like using the application? (1: "not at all", 7: "very much"), 2) How would you rate the difficulty level of using the application? (1: "definitely too easy", 7: "definitely too difficult"), and 3) Would you like to share any thoughts about the app? (open-ended question). Data obtained via CORTO implementation will be coded deductively using the process outlined by Saldana (2016) and using the four categories identified by Lukka et al. (2024) as high-level guidance ((1) contextual use, (2) interaction-elicited emotional experience, (3) usability, and (4) technical issues.), with more detailed coding examined as subdomains.

Time frame
During the 4-week intervention period and 1-month follow-up period

Locations

This trial has no locations.

Sponsors and contacts

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University of Social Sciences and Humanities, Warsaw

Lead sponsor

Polish Japanese Academy of Information Technology

Collaborator

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