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

NCT06570694 | Not Yet Recruiting

• 1 other identifier: SWPS-ECL-WKEB90/11/2023
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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:

• 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).

Conditions

Depression; Anxiety; Rumination

Keywords

Rumination; Experiential Avoidance; Depression; Anxiety; Ecological momentary intervention

Outcome Measures

Primary Outcomes (11)

• 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').

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

• 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.

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

• 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.

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

• 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)

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

• Cognitive avoidance using the CAQ

  A 25-item measure of five worry-related cognitive avoidance strategies (thought suppression, thought substitution, distraction, avoidance of threatening stimuli, transformation of images into thoughts). The scale comprises five subscales, each containing five items, which represent individual cognitive avoidance strategies (avoidance of threatening stimuli, distraction, thought substitution, thought suppression, transformation of images into thoughts). Respondents answer on a five-point scale (1: not at all applicable, to 5: very applicable), with higher scores indicating greater presence of cognitive avoidance.

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

• Experiential avoidance using the BEAQ.

  A 15-item short-version of the Multidimensional Experiential Avoidance Questionnaire, measuring EA content across six dimensions. Respondents provide answers to pre-determined statements along a 6-point Likert scale ('1': strongly disagree; to '6': strongly agree), with higher scores indicating a greater presence of experiential avoidance.

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

• Daily Sampling Items (1: Repetitive Negative Thinking Items)

  Nine items relating to different dimensions of repetitive negative thinking derived from the scale by Rosenkrantz et al. (2020) (feelings, problems, past, future, duration, distress, repetitiveness, intrusiveness, uncontrollability). These are answered on a scale from 1-7 (1: "not at all", 7: "very much"), with a higher overall score indicating a greater presence of issues with repetitive negative thinking.

  Once daily for 30 days

• Daily Sampling Items (2: Depression)

  Three items developed from the scale by Krejtz et al. (2016), which ask the participant about their day (1: "very negative", 7: "very positive"), the extent to which they felt positive about themselves that day (1: "not at all", 7: "very much") and how they are feeling about tomorrow (1: "very negative", 7: "very positive"). Higher total scores indicate greater severity of difficulties with depression on that day.

  Once daily for 30 days

• Daily Sampling Items (3: Affect)

  Four closed-ended items adapted from Pe et al. (2013) (rated on a scale of 1: "not at all", to 7: "very much"), which ask the participant about the extent to which they felt nervous/anxious, sad, angry, and disgusted during the day. Additionally, an open-ended item is presented asking participants to 'Choose the emotion that you felt the strongest - what useful function could it have played for you today?'

  Once daily for 30 days

• Daily Sampling Items (4: Goals)

  Adapted from Moberly \& Watkins (2010), participants are asked to enter a goal of importance to them during the day. Two follow-up questions then ask: 1) How important was this goal? (1: "not at all", 7: "very much"), and 2) To what extent did you manage to achieve this goal? (1: "not at all", 7: "very much")

  Once daily for 30 days

• Daily Sampling Items (5: Rumination Outcomes)

  Three items assessing the productivity of the individual's engagement in rumination, emotional discomfort resulting from rumination, and rumination-induced motivation during the day: 1) How productive was your rumination today? (1: "not at all", 7: "very much"), 2) How difficult/painful/comfortable was this reflection for you? (1: "not at all", 7: "very much"), and 3) Did it motivate you to take specific action? (1: "definitely not, 7: "definitely yes")

  Once daily for 30 days

Secondary Outcomes (1)

• Time spent using the application

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

Other Outcomes (1)

• Ongoing Application Development Feedback (CORTO)

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

Study Arms (4)

Intervention Group 1: Concurrent Therapist Support

EXPERIMENTAL

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.

Behavioral: OverThinking

Intervention Group 2: No Concurrent Therapist Support

EXPERIMENTAL

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.

Behavioral: OverThinking

Partial Intervention

NO 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.

Control

NO INTERVENTION

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.

Interventions

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.

Intervention Group 1: Concurrent Therapist Support; Intervention Group 2: No Concurrent Therapist Support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Self-reporting problems with repetitive negative thinking.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Social Sciences and Humanities, Warsaw: lead
• Polish Japanese Academy of Information Technology: collaborator

Related Publications (1)

• 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.

  PMID: 40424024 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders; Rumination Syndrome

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Gastrointestinal Diseases; Digestive System Diseases; Feeding and Eating Disorders

Study Officials

• Monika Kornacka, PhD

  SWPS University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Monika Kornacka, PhD

CONTACT

+48 533 577 141; mkornacka@swps.edu.pl

Steven Barnes, PhD

CONTACT

+48 515 121 270; sbarnes@swps.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be allocated to condition via a random number generator and will be provided with trial instructions pertaining only to their allocated condition. Trial participants will not be provided with any information relating to the remaining three conditions in the trial until the 1-month follow-up period has elapsed. 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Four arm parallel-group trial: (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).

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 26, 2024
• Study Start: May 1, 2025
• Primary Completion: June 30, 2025
• Study Completion: July 30, 2025
• Last Updated: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will become publicly available once the trial has concluded and once the outcomes have been published in a peer-reviewed outlet. The investigators do not anticipate any expiration date for the availability of this data once publicly disseminated.