RCT Protocol for 'OverThinking': A Mobile EMI for Reducing Experiential Avoidance
NCT ID: NCT06570694
Last Updated: 2025-05-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
60 participants
INTERVENTIONAL
2025-05-01
2025-07-30
Brief Summary
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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).
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Detailed Description
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The main questions which the trial aims to answer are as follows:
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).
The trial comprises of a four-arm, parallel group randomised-controlled trial (RCT). Participation lasts approximately 2 months (including eligibility screening and random allocation to condition (random number generator), a four-week intervention period delivered via the mobile application and supplemented with daily assessments, post-intervention assessments, and 1-month follow-up (wherein the app will remain available for self-directed use without daily sampling), concluding with follow-up assessments and measurement of any engagement with the application during this period.
At the point of 1-month follow-up, participants previously allocated to the control groups will receive access to the application (without the feature of daily sampling) and will be provided with guidance on using the intervention content. While a 3-month follow-up assessment of intervention participants is planned, the 1-month interval allows for control participants to access intervention content without being subject to extensive waitlist delay. Active control groups have been chosen to not artificially inflate comparisons with outcomes in the intervention conditions.
Analysis:
Analysis of changes in outcomes across pre-, post- and follow-up-measures (PTQ, EBQ, PBRS, NBRS, HADS, CAQ, and BEAQ) across all four conditions will be conducted using mixed-design ANOVA.
Additionally for all conditions, multilevel models (daily observations on level 1 nested in participants on level 2) will be used on daily sampling data to assess the links between avoidance and mood and between rumination and mood, and to determine if each of these links is moderated by condition. Participants respond to these items once daily in the evening, in response an in-app reminder alert (the time of the alert can be determined by the participant). All daily sampling items have been provided in the 'Measures' section.
Mixed-design ANCOVA will be used for the two intervention groups to examine if time spent engaging with the application content acts as a covariate in intervention outcomes (PTQ, EBQ, PBRS, NBRS, HADS, CAQ, and BEAQ).
Finally, ongoing development of the application will be assisted using in-app user-feedback data obtained via CORTO implementation (three items with gather a combination of quantitative and qualitative data \[Lukka et al,. 2024\]). This data 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
(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).
TREATMENT
SINGLE
The member of the research team responsible for analysing the data will additionally be blinded to the allocation of participants. This will be anonymised for them in the dataset without accompanying explanatory label.
Study Groups
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Intervention Group 1: Concurrent Therapist Support
Participants will receive the four-week intervention via the mobile application. This will be supplemented with asynchronous written support from a CBT practitioner (qualified or after the second year of their training) via WhatsApp and will be available twice a week to relevant participants at specific times predetermined by the therapist. Participants will be available to utilise this support but will not be directed to do so. Participants in this condition will, as part of their use of the application, participate in providing daily sampling, which includes emotion valuation questions.
OverThinking
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.
Intervention Group 2: No Concurrent Therapist Support
Participants will receive the four-week intervention via the mobile application. No concurrent therapist support will be provided in this group. Participants in this condition will, as part of their use of the application, participate in providing daily sampling, which includes emotion valuation questions.
OverThinking
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.
Partial Intervention
Partial intervention group: This group will not receive the four-week mobile intervention, but will participate in providing daily sampling (via web-based form), which includes emotion valuation questions.
No interventions assigned to this group
Control
Control group: This group will not receive the four-week mobile intervention, but will participate in providing daily sampling (via web-based form) - this does not include emotion valuation questions.
No interventions assigned to this group
Interventions
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OverThinking
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Currently in receipt of any form of psychotherapy.
* Currently in receipt of any form of psychiatric medication.
18 Years
ALL
No
Sponsors
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Polish Japanese Academy of Information Technology
UNKNOWN
University of Social Sciences and Humanities, Warsaw
OTHER
Responsible Party
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Principal Investigators
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Monika Kornacka, PhD
Role: PRINCIPAL_INVESTIGATOR
SWPS University
Central Contacts
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References
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Barnes S, Szastok M, Para M, Morawiec F, Grzeszczuk M, Wojcik S, Karpowicz B, Zinevych P, Jaskulska A, Kopec W, Kornacka M. A Mobile Ecological Momentary Intervention for Reducing Experiential Avoidance in the Context of Rumination: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 May 27;14:e66067. doi: 10.2196/66067.
Other Identifiers
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SWPS-ECL-WKEB90/11/2023
Identifier Type: -
Identifier Source: org_study_id
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