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Completed

NCT Number: NCT05294809

Psychological Mobile Interventions to Reduce Distress

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).

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Key information

Conditions

Psychological Distress Behavior Digestive System Diseases Emotional Regulation Feeding and Eating Disorders Gastrointestinal Diseases Mental Disorders Rumination Syndrome Self-Control Social Behavior

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Babes-Bolyai University

Cluj-Napoca, 400084, Romania

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-65 years old
  • Have access and able to use a smartphone

Treatment and study plan

PsyPills

Behavioral

Prescribing personalized rational thinking strategies to change levels of dysfunctional emotionality.

Online-Contingent Attention Training, OCAT

Behavioral

Facilitating the disengagement from negative content and engagement of positive one of personally relevant information by providing instruction and feedback on performance.

shamOCAT

Behavioral

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.

Primary outcomes

  1. Depressive, Anxiety, and Stress Symptoms

    Time frame: Baseline

    DASS-21, with scores from 0 to 63, higher scores meaning worse outcomes

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. Functional Reappraisal

    Time frame: Baseline

    Acceptance, Putting into perspective and inversed scores of Catastrophizing subscales of CERQ-SF, with scores from 6 to 30, higher scores meaning better outcomes

  2. Change from Baseline Functional Reappraisal at 5 days

    Time frame: Mid of intervention (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

  3. Change from Baseline Functional Reappraisal at 10 days

    Time frame: Post intervention (10 day)

    Acceptance, Putting into perspective and inversed scores of Catastrophizing subscales of CERQ-SF, with scores from 6 to 30, higher scores meaning better outcomes

  4. Change from Baseline Functional Reappraisal at 1 month

    Time frame: Follow-up (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

  5. Positive Reappraisal

    Time frame: Baseline

    Positive reappraisal subscale of CERQ-SF, with scores from 2 to 10, higher scores meaning better outcomes

  6. Change from Baseline Positive Reappraisal at 5 days

    Time frame: Mid of intervention (5 days)

    Positive reappraisal subscale of CERQ-SF, with scores from 2 to 10, higher scores meaning better outcomes

  7. Change from Baseline Positive Reappraisal at 10 days

    Time frame: Post intervention (10 days)

    Positive reappraisal subscale of CERQ-SF, with scores from 2 to 10, higher scores meaning better outcomes

  8. Change from Baseline Positive Reappraisal at 1 month

    Time frame: Follow-up (1 month)

    Positive reappraisal subscale of CERQ-SF, with scores from 2 to 10, higher scores meaning better outcomes

  9. Rational and Irrational Beliefs

    Time frame: Baseline

    HABS-AV, with scores from 24 to 120, with higher scores meaning worse outcomes

  10. Change from Baseline Rational and Irrational Beliefs at 5 days

    Time frame: Mid of intervention (5 days)

    HABS-AV, with scores from 24 to 120, with higher scores meaning worse outcomes

  11. Change from Baseline Rational and Irrational Beliefs at 10 days

    Time frame: Post intervention (10 days)

    HABS-AV, with scores from 24 to 120, with higher scores meaning worse outcomes

  12. Change from Baseline Rational and Irrational Beliefs at 1 month

    Time frame: Follow-up (1 month)

    HABS-AV, with scores from 24 to 120, with higher scores meaning worse outcomes

  13. Rumination

    Time frame: Baseline

    Focus on thought/rumination subscale of CERQ-SF, with scores from 2 to 10, higher scores meaning worse outcomes

  14. Change from Baseline Rumination at 5 days

    Time frame: Mid of intervention (5 days)

    Focus on thought/rumination subscale of CERQ-SF, with scores from 2 to 10, higher scores meaning worse outcomes

  15. Change from Baseline Rumination at 10 days

    Time frame: Post intervention (10 days)

    Focus on thought/rumination subscale of CERQ-SF, with scores from 2 to 10, higher scores meaning worse outcomes

  16. Change from Baseline Rumination at 1 month

    Time frame: Follow-up (1 month)

    Focus on thought/rumination subscale of CERQ-SF, with scores from 2 to 10, higher scores meaning worse outcomes

  17. Functional and Dysfunctional Emotions

    Time frame: Baseline

    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

  18. Change from Baseline Functional and Dysfunctional Emotions at 5 days

    Time frame: Mid of intervention (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

  19. Change from Baseline Functional and Dysfunctional Emotions at 10 days

    Time frame: Post intervention (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

  20. Change from Baseline Functional and Dysfunctional Emotions at 1 month

    Time frame: Follow-up (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

  21. Attention bias

    Time frame: Baseline

    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

  22. Change from Baseline Attention Bias at 5 days

    Time frame: Mid of intervention (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

  23. Change from Baseline Attention Bias at 10 days

    Time frame: Post intervention (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

  24. Change from Baseline Attention Bias at 1 month

    Time frame: Follow-up (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

Other outcomes

  1. Experience Sampling Methods (ESM) questionnaire

    Time frame: During the intervention (3 times daily from day 1 to day 10)

    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

Sponsors and collaborators

Lead sponsor

Babes-Bolyai University

Other

Collaborators

  • Universidad Complutense de Madrid

Registry information

Official study 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)

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 24, 2022
Registry last updated
Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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