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

StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record status
This record was last updated May 2, 2025 (before its estimated June 30, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Notable Primary completion date: Oct 31, 2024 to Jun 30, 2025
    • Start date: Sep 1, 2024 to May 1, 2025
    • Study completion date: Nov 30, 2024 to Jul 30, 2025
    v3
  2. Minor Study description expanded, about 1 wordv2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT06570694
Lead Sponsor University of Social Sciences and Humanities, Warsaw
Collaborators: Polish Japanese Academy of Information Technology
Conditions
(from sponsor)
Depression, Anxiety, Rumination
Related terms Anxiety Disorders, Depression, Rumination Syndrome
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov