An interventional study of PsyPills and Online-Contingent Attention Training, OCAT in Psychological Distress, sponsored by Babes-Bolyai University. Completed at 1 site in Romania. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-02-07.
Sponsored by Babes-Bolyai University · Not applicable, Interventional, and Treatment
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Among 11 studies in Emotional Regulation with a site in Romania — 1 open to participants now, 1 under way, none of them phase 3. Emotional Regulation · Romania.
Among the 11 studies in Emotional Regulation with a site in Romania, this one has the largest enrollment, is one of 3 that started in 2022, is one of 11 with no phase, and was the 3rd registered.
547 studies on the registry are indexed under Emotional Regulation; 190 are open to participants now.
Browse Emotional Regulation studies →1 of the 11 studies in Emotional Regulation with a site in Romania is open now. Recruiting first, the newest first:
George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures · Sites in Romania
Ages 18–65 · Healthy volunteers
A study can be open while its sites in Romania have not opened yet or have stopped. Only those recruiting at a site in Romania →
Of the 136 Emotional Regulation studies recruiting now, 36 (26%) set no upper age limit and 96 (71%) stop at 75 or younger; 47 take children under 18; 66 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
11 studies; the count open now beside each. This study's row is marked.
First in 2021; this study’s year is marked. 3 started in 2022.
This study's enrollment of 450 is above the median of 80 across 500 interventional studies indexed under Emotional Regulation.
Median enrollment 230 across the 11 interventional studies. Of the 10 that completed or were terminated, 0 (0%) have results posted.
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None of the 11 has an industry lead sponsor. The 3 most frequent:
Babes-Bolyai University is the lead sponsor of 51 studies on the registry; 13 are open to participants now.
Babes-Bolyai University has 9 studies filed under Emotional Regulation — fewer than ten, so there is no comparison to draw.
1 of the studies in Emotional Regulation with a site in Romania that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07589114George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu MuresREM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift | 2026-12 |
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Among the 11 studies in Emotional Regulation with a site in Romania, from their registry updates:
Nothing recorded among them since 2026-09-25.
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Investigating the effectiveness of two mobile psychological interventions and the mechanisms of change involved in reducing the symptoms of depression, anxiety and stress, on an adult population with a mild to moderate level of symptoms (sub-clinical).
The research design will be a 3-arm controlled clinical trial, with 4 waves of data collection. Once selected using a symptomatic screening questionnaire, participants will be randomly assigned to one of three conditions: 2 experimental conditions (PsyPills and OCAT) and an active control group (shamOCAT).
Measurements will be collected before allocation (baseline), during the intervention (through a momentary ecological assessment paradigm), at the end (post) and at an interval of one month after the intervention (follow-up). Among the constructs evaluated are symptomatic level, affectivity, cognitive processes, emotional regulation and attentional bias. All measurement steps will be collected online.
The interventions consist of an attentional training (Online-Contingent Attention Training, OCAT) which seeks to facilitate the disengagement from the negative content and the engagement on the positive of some personally relevant information by providing instructions and feedback on performance; and prescribing personalized rational thinking strategies to change the intensity of dysfunctional emotionality (PsyPills). The active control group consists of a "fake" version of OCAT (shamOCAT), by offering the same attentional training, without training and feedback on performance. All interventions are delivered in the form of smartphone applications.
Inclusion Criteria:
The participants randomized in this condition will receive the mobile health application "PsyPills".
Behavioral: PsyPills
The participants randomized in this condition will receive the mobile health application "OCAT".
Behavioral: Online-Contingent Attention Training, OCAT
The active control group, which consists of the "fake" version of the OCAT intervention, by offering the same attentional training, without training and feedback on performance.
Behavioral: shamOCAT
Prescribing personalized rational thinking strategies to change levels of dysfunctional emotionality.
Facilitating the disengagement from negative content and engagement of positive one of personally relevant information by providing instruction and feedback on performance.
The active control group, which consists of the "fake" version of the OCAT intervention, by offering the same attentional training, without training and feedback on performance.
Depressive, Anxiety, and Stress Symptoms
DASS-21, with scores from 0 to 63, higher scores meaning worse outcomes
Time frame: Baseline
Change from Baseline Depressive, Anxiety, and Stress Symptoms at 5 days
DASS-21, with scores from 0 to 63, higher scores meaning worse outcomes
Time frame: Mid of intervention (5 days)
Change from Baseline Depressive, Anxiety, and Stress Symptoms at 10 days
DASS-21, with scores from 0 to 63, higher scores meaning worse outcomes
Time frame: Post intervention (10 day)
Change from Baseline Depressive, Anxiety, and Stress Symptoms at 1 month
DASS-21, with scores from 0 to 63, higher scores meaning worse outcomes
Time frame: Follow-up (1 month)
Functional Reappraisal
Acceptance, Putting into perspective and inversed scores of Catastrophizing subscales of CERQ-SF, with scores from 6 to 30, higher scores meaning better outcomes
Time frame: Baseline
Change from Baseline Functional Reappraisal at 5 days
Acceptance, Putting into perspective and inversed scores of Catastrophizing subscales of CERQ-SF, with scores from 6 to 30, higher scores meaning better outcomes
Time frame: Mid of intervention (5 days)
Change from Baseline Functional Reappraisal at 10 days
Acceptance, Putting into perspective and inversed scores of Catastrophizing subscales of CERQ-SF, with scores from 6 to 30, higher scores meaning better outcomes
Time frame: Post intervention (10 day)
Change from Baseline Functional Reappraisal at 1 month
Acceptance, Putting into perspective and inversed scores of Catastrophizing subscales of CERQ-SF, with scores from 6 to 30, higher scores meaning better outcomes
Time frame: Follow-up (1 month)
Positive Reappraisal
Positive reappraisal subscale of CERQ-SF, with scores from 2 to 10, higher scores meaning better outcomes
Time frame: Baseline
Change from Baseline Positive Reappraisal at 5 days
Positive reappraisal subscale of CERQ-SF, with scores from 2 to 10, higher scores meaning better outcomes
Time frame: Mid of intervention (5 days)
Change from Baseline Positive Reappraisal at 10 days
Positive reappraisal subscale of CERQ-SF, with scores from 2 to 10, higher scores meaning better outcomes
Time frame: Post intervention (10 days)
Change from Baseline Positive Reappraisal at 1 month
Positive reappraisal subscale of CERQ-SF, with scores from 2 to 10, higher scores meaning better outcomes
Time frame: Follow-up (1 month)
Rational and Irrational Beliefs
HABS-AV, with scores from 24 to 120, with higher scores meaning worse outcomes
Time frame: Baseline
Change from Baseline Rational and Irrational Beliefs at 5 days
HABS-AV, with scores from 24 to 120, with higher scores meaning worse outcomes
Time frame: Mid of intervention (5 days)
Change from Baseline Rational and Irrational Beliefs at 10 days
HABS-AV, with scores from 24 to 120, with higher scores meaning worse outcomes
Time frame: Post intervention (10 days)
Change from Baseline Rational and Irrational Beliefs at 1 month
HABS-AV, with scores from 24 to 120, with higher scores meaning worse outcomes
Time frame: Follow-up (1 month)
Rumination
Focus on thought/rumination subscale of CERQ-SF, with scores from 2 to 10, higher scores meaning worse outcomes
Time frame: Baseline
Change from Baseline Rumination at 5 days
Focus on thought/rumination subscale of CERQ-SF, with scores from 2 to 10, higher scores meaning worse outcomes
Time frame: Mid of intervention (5 days)
Change from Baseline Rumination at 10 days
Focus on thought/rumination subscale of CERQ-SF, with scores from 2 to 10, higher scores meaning worse outcomes
Time frame: Post intervention (10 days)
Change from Baseline Rumination at 1 month
Focus on thought/rumination subscale of CERQ-SF, with scores from 2 to 10, higher scores meaning worse outcomes
Time frame: Follow-up (1 month)
Functional and Dysfunctional Emotions
PAD, functional emotions subscale, with scores from 12 to 60, and dysfunctional emotions subscale, with scores from 14 to 70, with higher scores meaning worse outcomes
Time frame: Baseline
Change from Baseline Functional and Dysfunctional Emotions at 5 days
PAD, functional emotions subscale, with scores from 12 to 60, and dysfunctional emotions subscale, with scores from 14 to 70, with higher scores meaning worse outcomes
Time frame: Mid of intervention (5 days)
Change from Baseline Functional and Dysfunctional Emotions at 10 days
PAD, functional emotions subscale, with scores from 12 to 60, and dysfunctional emotions subscale, with scores from 14 to 70, with higher scores meaning worse outcomes
Time frame: Post intervention (10 days)
Change from Baseline Functional and Dysfunctional Emotions at 1 month
PAD, functional emotions subscale, with scores from 12 to 60, and dysfunctional emotions subscale, with scores from 14 to 70, with higher scores meaning worse outcomes
Time frame: Follow-up (1 month)
Attention bias
Engagement in positive information and inhibition of negative information web measures with an index of attention bias for processing positive vs. negative material computed by dividing the total fixation time on positive words by the total fixation time on emotional (positive and negative) words
Time frame: Baseline
Change from Baseline Attention Bias at 5 days
Engagement in positive information and inhibition of negative information web measures with an index of attention bias for processing positive vs. negative material computed by dividing the total fixation time on positive words by the total fixation time on emotional (positive and negative) words
Time frame: Mid of intervention (5 days)
Change from Baseline Attention Bias at 10 days
Engagement in positive information and inhibition of negative information web measures with an index of attention bias for processing positive vs. negative material computed by dividing the total fixation time on positive words by the total fixation time on emotional (positive and negative) words
Time frame: Post intervention (10 days)
Change from Baseline Attention Bias at 1 month
Engagement in positive information and inhibition of negative information web measures with an index of attention bias for processing positive vs. negative material computed by dividing the total fixation time on positive words by the total fixation time on emotional (positive and negative) words
Time frame: Follow-up (1 month)
Experience Sampling Methods (ESM) questionnaire
Items selected from the main scales, including 8 items for rational/irrational beliefs, 9 affective state items, 5 items from the subscales of interest of CERQ-SF, on a visual analog scale (VAS) format; the direction of scores is the same with those of the original scales and subscales from which th items are taken from
Time frame: During the intervention (3 times daily from day 1 to day 10)
Ran from Jun 2022 to primary completion in Oct 2023, 16 months.
Of 391 non-industry interventional studies with no phase under Emotional Regulation, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 36. This study's 16 months is below that.
Counting every sponsor, half of 397 studies reached it within 18 months; a quarter within 6 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Babes-Bolyai University