Psychological Mobile Interventions to Reduce Distress

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).

Study Overview

• Status: Completed
• Conditions: Psychological Distress
• Intervention / Treatment: Behavioral: PsyPills; Behavioral: Online-Contingent Attention Training, OCAT; Behavioral: shamOCAT

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 Type: Interventional
• Enrollment (Actual): 450
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Romania
  • Cluj-Napoca, Romania, 400084
    • Babes-Bolyai University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PsyPills; The participants randomized in this condition will receive the mobile health application "PsyPills".	Behavioral: PsyPills; Prescribing personalized rational thinking strategies to change levels of dysfunctional emotionality.
Experimental: OCAT; The participants randomized in this condition will receive the mobile health application "OCAT".	Behavioral: Online-Contingent Attention Training, OCAT; Facilitating the disengagement from negative content and engagement of positive one of personally relevant information by providing instruction and feedback on performance.
Placebo Comparator: OCAT sham; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depressive, Anxiety, and Stress Symptoms	DASS-21, with scores from 0 to 63, higher scores meaning worse outcomes	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	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	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	Follow-up (1 month)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	Follow-up (1 month)
Positive Reappraisal	Positive reappraisal subscale of CERQ-SF, with scores from 2 to 10, higher scores meaning better outcomes	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	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	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	Follow-up (1 month)
Rational and Irrational Beliefs	HABS-AV, with scores from 24 to 120, with higher scores meaning worse outcomes	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	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	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	Follow-up (1 month)
Rumination	Focus on thought/rumination subscale of CERQ-SF, with scores from 2 to 10, higher scores meaning worse outcomes	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	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	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	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	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	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	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	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	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	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	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	Follow-up (1 month)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	During the intervention (3 times daily from day 1 to day 10)

Collaborators and Investigators

• Sponsor: Babes-Bolyai University
• Collaborators: Universidad Complutense de Madrid
• Investigators: Study Director: Oana David, Dr., Babes-Bolyai University

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2022
• Primary Completion (Actual): October 29, 2023
• Study Completion (Actual): October 29, 2023

Study Registration Dates

• First Submitted: February 23, 2022
• First Submitted That Met QC Criteria: March 15, 2022
• First Posted (Actual): March 24, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 5, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: mHealth; psychological distress; rumination; emotion regulation; mobile mental health; attention bias training; digital CBT; functional reappraisal
• Other Study ID Numbers: 13.912 / 29.10.2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No