Psychological DistressNCT05294809
Psychological Mobile Interventions to Reduce Distress
A study testing PsyPills and Online-Contingent Attention Training, OCAT in people with Psychological Distress, run by Babes-Bolyai University at 1 site in Romania.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psychological Distress
- What is being tested?
- PsyPills and Online-Contingent Attention Training, OCAT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 450 participants
- Where
- 1 siteRomania
- Study dates
- 12 Jun 2022to 29 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years old
- Have access and able to use a smartphone
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness and Mechanisms of Change of Two Mobile Psychological Interventions in Reducing Depressive, Anxiety and Stress Symptoms: PsyPills and Online-Contingent Attention Training (OCAT)
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).
Read the detailed description
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.
- Conditions
- Psychological Distress
- Being tested
- PsyPills, Online-Contingent Attention Training, OCAT, shamOCAT
- Keywords
- mobile mental health, mHealth, attention bias training, psychological distress, digital CBT, emotion regulation, functional reappraisal, rumination
- Medical subject headings
- Emotional Regulation, Rumination Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsyPillsBehavioural
Prescribing personalized rational thinking strategies to change levels of dysfunctional emotionality.
Online-Contingent Attention Training, OCATBehavioural
Facilitating the disengagement from negative content and engagement of positive one of personally relevant information by providing instruction and feedback on performance.
shamOCATBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| PsyPills | Experimental | The participants randomized in this condition will receive the mobile health application "PsyPills". Receives: Behavioral: PsyPills |
| OCAT | Experimental | The participants randomized in this condition will receive the mobile health application "OCAT". Receives: Behavioral: Online-Contingent Attention Training, OCAT |
| OCAT sham | Placebo comparator | 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. Receives: Behavioral: shamOCAT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive, Anxiety, and Stress Symptoms
DASS-21, with scores from 0 to 63, higher scores meaning worse outcomes
Measured: 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
Measured: 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
Measured: 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
Measured: Follow-up (1 month)
Secondary outcomes (24)
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
Measured: 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
Measured: 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
Measured: 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
Measured: Follow-up (1 month)
Positive Reappraisal
Positive reappraisal subscale of CERQ-SF, with scores from 2 to 10, higher scores meaning better outcomes
Measured: 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
Measured: 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
Measured: 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
Measured: Follow-up (1 month)
Rational and Irrational Beliefs
HABS-AV, with scores from 24 to 120, with higher scores meaning worse outcomes
Measured: 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
Measured: 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
Measured: 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
Measured: Follow-up (1 month)
Rumination
Focus on thought/rumination subscale of CERQ-SF, with scores from 2 to 10, higher scores meaning worse outcomes
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Follow-up (1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start12 Jun 2022
- Primary completion29 Oct 2023
- Study completion29 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological DistressStudies 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
- Participants will be randomly assigned to one of three conditions: 2 experimental conditions and an active control group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Babes-Bolyai University
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Complutense de Madrid
- Responsible party
- Principal investigator, Sîrbu Vasile, Babes-Bolyai University
- Investigators
- Oana David, Dr., Study director, Babes-Bolyai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05294809
- Sponsor's protocol ID
- 13.912 / 29.10.2021
- Status last verified
- Feb 2025
- First submitted
- 23 Feb 2022
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Mechanisms of Change of Two Mobile Psychological Interventions in Reducing Depressive, Anxiety and Stress Symptoms: PsyPills and Online-Contingent Attention Training (OCAT)
- ClinicalTrials.gov ID
- NCT05294809
- Acronym / sponsor ID
- 13.912 / 29.10.2021
- Conditions
- Psychological Distress
- Keywords
- mobile mental health, mHealth, attention bias training, psychological distress, digital CBT, emotion regulation, functional reappraisal, rumination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Babes-Bolyai UniversityUniversity, hospital or other
- Collaborators
- Universidad Complutense de Madrid
- Study start
- 12 Jun 2022 (actual)
- Primary completion
- 29 Oct 2023 (actual)
- Study completion
- 29 Oct 2023 (actual)
- First posted
- 24 Mar 2022 (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.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned to one of three conditions: 2 experimental conditions and an active control group.
| Arm | Type | Receives |
|---|---|---|
| PsyPills | Experimental | Behavioral: PsyPillsThe participants randomized in this condition will receive the mobile health application "PsyPills". |
| OCAT | Experimental | Behavioral: Online-Contingent Attention Training, OCATThe participants randomized in this condition will receive the mobile health application "OCAT". |
| OCAT sham | Placebo comparator | Behavioral: shamOCATThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18-65 years old
- Have access and able to use a smartphone
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| PsyPillsPrescribing personalized rational thinking strategies to change levels of dysfunctional emotionality. | Behavioural | PsyPills |
| Online-Contingent Attention Training, OCATFacilitating the disengagement from negative content and engagement of positive one of personally relevant information by providing instruction and feedback on performance. | Behavioural | OCAT |
| shamOCATThe 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. | Behavioural | OCAT sham |
Primary outcome
Depressive, Anxiety, and Stress Symptoms
Time frame: Baseline
DASS-21, with scores from 0 to 63, higher scores meaning worse outcomes
Change from Baseline Depressive, Anxiety, and Stress Symptoms at 5 days
Time frame: Mid of intervention (5 days)
DASS-21, with scores from 0 to 63, higher scores meaning worse outcomes
Change from Baseline Depressive, Anxiety, and Stress Symptoms at 10 days
Time frame: Post intervention (10 day)
DASS-21, with scores from 0 to 63, higher scores meaning worse outcomes
Change from Baseline Depressive, Anxiety, and Stress Symptoms at 1 month
Time frame: Follow-up (1 month)
DASS-21, with scores from 0 to 63, higher scores meaning worse outcomes
24 secondary outcomes
Functional Reappraisal
Time frame: Baseline
Change from Baseline Functional Reappraisal at 5 days
Time frame: Mid of intervention (5 days)
Change from Baseline Functional Reappraisal at 10 days
Time frame: Post intervention (10 day)
Change from Baseline Functional Reappraisal at 1 month
Time frame: Follow-up (1 month)
Positive Reappraisal
Time frame: Baseline
Change from Baseline Positive Reappraisal at 5 days
Time frame: Mid of intervention (5 days)
Change from Baseline Positive Reappraisal at 10 days
Time frame: Post intervention (10 days)
Change from Baseline Positive Reappraisal at 1 month
Time frame: Follow-up (1 month)
Rational and Irrational Beliefs
Time frame: Baseline
Change from Baseline Rational and Irrational Beliefs at 5 days
Time frame: Mid of intervention (5 days)
Change from Baseline Rational and Irrational Beliefs at 10 days
Time frame: Post intervention (10 days)
Change from Baseline Rational and Irrational Beliefs at 1 month
Time frame: Follow-up (1 month)
Rumination
Time frame: Baseline
Change from Baseline Rumination at 5 days
Time frame: Mid of intervention (5 days)
Change from Baseline Rumination at 10 days
Time frame: Post intervention (10 days)
Change from Baseline Rumination at 1 month
Time frame: Follow-up (1 month)
Functional and Dysfunctional Emotions
Time frame: Baseline
Change from Baseline Functional and Dysfunctional Emotions at 5 days
Time frame: Mid of intervention (5 days)
Change from Baseline Functional and Dysfunctional Emotions at 10 days
Time frame: Post intervention (10 days)
Change from Baseline Functional and Dysfunctional Emotions at 1 month
Time frame: Follow-up (1 month)
Attention bias
Time frame: Baseline
Change from Baseline Attention Bias at 5 days
Time frame: Mid of intervention (5 days)
Change from Baseline Attention Bias at 10 days
Time frame: Post intervention (10 days)
Change from Baseline Attention Bias at 1 month
Time frame: Follow-up (1 month)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
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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. This study is not recruiting at the moment.
Oana David, Dr. study director
Babes-Bolyai University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PsyPills and Online-Contingent Attention Training, OCAT in people with Psychological Distress, run by Babes-Bolyai University at 1 site in Romania.
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 2 inclusion and 0 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: finished, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive, Anxiety, and Stress Symptoms (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Feb 2025.