DepressionNCT06570694
RCT Protocol for 'OverThinking': A Mobile EMI for Reducing Experiential Avoidance
A study testing OverThinking in people with Depression and Anxiety, run by University of Social Sciences and Humanities, Warsaw.
Trial 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: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Anxiety, Rumination
- What is being tested?
- OverThinking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2025to 30 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-reporting problems with repetitive negative thinking.
Who cannot join
- 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.
- Note: Participants who hold a psychiatric diagnosis will not be excluded from the trial provided they meet the inclusion criterion and do not meet any of the exclusion criteria listed above.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Mobile Ecological Momentary Intervention for Reducing Experiential Avoidance in the Context of Rumination: Protocol for a Randomised-Controlled 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:
Read more
- 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.
- By examining (1) above, to confirm the role played by avoidance in repetitive negative thinking.
- 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.
- 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).
Read the detailed description
The trial aims to examine whether a mobile application-based intervention for experiential avoidance in the context of 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 which the trial aims to answer are as follows:
- 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.
- By examining (1) above, to confirm the role played by avoidance in repetitive negative thinking.
- 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.
- 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
- Depression, Anxiety, Rumination
- Being tested
- OverThinking
- Keywords
- Rumination, Experiential Avoidance, Depression, Anxiety, Ecological momentary intervention
- Medical subject headings
- Depression, Anxiety Disorders, Rumination Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OverThinkingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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').
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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?'
Measured: 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")
Measured: 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")
Measured: Once daily for 30 days
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.
Measured: During the 4-week intervention period and 1-month follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start1 May 2025 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Social Sciences and Humanities, Warsaw
- Sponsor type
- University, hospital or other
- Collaborators
- Polish Japanese Academy of Information Technology
- Responsible party
- Sponsor
- Investigators
- Monika Kornacka, PhD, Principal investigator, SWPS University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06570694
- Sponsor's protocol ID
- SWPS-ECL-WKEB90/11/2023
- Status last verified
- Apr 2025
- First submitted
- 19 Aug 2024
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Following the conclusion of the trial and the peer-reviewed publication of findings, data will be made available in anonymised form via the Open Science Framework.
Publications
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.
PubMed 40424024
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mobile Ecological Momentary Intervention for Reducing Experiential Avoidance in the Context of Rumination: Protocol for a Randomised-Controlled Trial
- ClinicalTrials.gov ID
- NCT06570694
- Acronym / sponsor ID
- SWPS-ECL-WKEB90/11/2023
- Conditions
- Depression, Anxiety, Rumination
- Keywords
- Rumination, Experiential Avoidance, Depression, Anxiety, Ecological momentary intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Social Sciences and Humanities, WarsawUniversity, hospital or other
- Collaborators
- Polish Japanese Academy of Information Technology
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 26 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- By examining (1) above, to confirm the role played by avoidance in repetitive negative thinking.
- 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.
- 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).
Detailed description
The trial aims to examine whether a mobile application-based intervention for experiential avoidance in the context of 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 which the trial aims to answer are as follows:
- 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.
- By examining (1) above, to confirm the role played by avoidance in repetitive negative thinking.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Intervention Group 1: Concurrent Therapist Support | Experimental | Behavioral: OverThinkingParticipants 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. |
| Intervention Group 2: No Concurrent Therapist Support | Experimental | Behavioral: OverThinkingParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Self-reporting problems with repetitive negative thinking.
Key exclusion criteria (4 listed)
- 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.
- Note: Participants who hold a psychiatric diagnosis will not be excluded from the trial provided they meet the inclusion criterion and do not meet any of the exclusion criteria listed above.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OverThinkingOverThinking 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. | Behavioural | Intervention Group 1: Concurrent Therapist Support, Intervention Group 2: No Concurrent Therapist Support |
Primary outcome
Perseverative thinking as measured by the Perseverative Thinking Questionnaire (PTQ)
Time frame: Two months (4-week intervention plus 1-month follow-up)
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').
Beliefs about emotions as measured by the Emotion Beliefs Questionnaire EBQ
Time frame: Two months (4-week intervention plus 1-month follow-up)
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.
Metacognitive beliefs about rumination using PBRS/NBRS
Time frame: Two months (4-week intervention plus 1-month follow-up)
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.
Hospital Anxiety and Depression Scale (HADS)
Time frame: Two months (4-week intervention plus 1-month follow-up)
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)
Cognitive avoidance using the CAQ
Time frame: Two months (4-week intervention plus 1-month follow-up)
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.
Experiential avoidance using the BEAQ.
Time frame: Two months (4-week intervention plus 1-month follow-up)
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.
Daily Sampling Items (1: Repetitive Negative Thinking Items)
Time frame: Once daily for 30 days
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.
Daily Sampling Items (2: Depression)
Time frame: Once daily for 30 days
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.
Daily Sampling Items (3: Affect)
Time frame: Once daily for 30 days
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?'
Daily Sampling Items (4: Goals)
Time frame: Once daily for 30 days
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")
Daily Sampling Items (5: Rumination Outcomes)
Time frame: Once daily for 30 days
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")
1 secondary outcome
Time spent using the application
Time frame: During the 4-week intervention period and 1-month follow-up period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Derived from this study: PubMed 40424024Barnes 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.
- Individual participant dataSharing planned: Yes. Following the conclusion of the trial and the peer-reviewed publication of findings, data will be made available in anonymised form via the Open Science Framework.
Related trials for Depression
RecruitingPhase 2
Study of Neuro-Cognitive Correlates of Pediatric Anxiety Disorders
Anxiety Disorders, Major Depressive Disorder
Recruiting
Virtual Reality Intervention to Improve Psychological Symptom Burden for Cancer Patients Undergoing Treatment
Adjustment Disorder, Anxiety Disorder
Recruiting
Teenthrive 2: Treatments for Improving Mood in Teens
Depression in Adolescence
Active, not recruiting
Developing and Testing an Online Pathway From Screening to Treatment for Depression in Oncology: iPath*D (Aim 2)
Cancer, Depression
RecruitingPhase 2
Psilocybin-assisted Therapy for Comorbid Major Depressive Disorder and Alcohol Use Disorder
Major Depressive Disorder (MDD), Alcohol Use Disorder (AUD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Monika Kornacka, PhD principal investigator
SWPS University
Questions about this trial
What is this clinical trial studying?
A study testing OverThinking in people with Depression and Anxiety, run by University of Social Sciences and Humanities, Warsaw.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Monika Kornacka, PhD (+48 533 577 141, mkornacka@swps.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perseverative thinking as measured by the Perseverative Thinking Questionnaire (PTQ) (time frame: Two months (4-week intervention plus 1-month follow-up)). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06570694, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2025.