Psychological Mobile Interventions to Reduce Distress

Psychological Distress Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05294809
• Other study ID #: 13.912 / 29.10.2021
• Status: Recruiting
• Phase: N/A
• Start date: June 12, 2022
• Est. completion date: February 2024

Study information

• Verified date: December 2023
• Source: Babes-Bolyai University
• Contact: Vasile Sîrbu, PhD student
• Phone: +40762405622
• Email: vasile.sirbu[@]ubbcluj.ro
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 430
• Est. completion date: February 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 18-65 years old

• Have access and able to use a smartphone

Related Conditions & MeSH terms

• Psychological Distress

Intervention

Behavioral:
• PsyPills
Prescribing personalized rational thinking strategies to change levels of dysfunctional emotionality.
• 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.
• 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.

Locations

Country	Name	City	State
Romania	Babes-Bolyai University	Cluj-Napoca

Sponsors (2)

Lead Sponsor	Collaborator
Babes-Bolyai University	Universidad Complutense de Madrid

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Primary	Depressive, Anxiety, and Stress Symptoms	DASS-21, with scores from 0 to 63, higher scores meaning worse outcomes	Baseline
Primary	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)
Primary	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)
Primary	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	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Positive Reappraisal	Positive reappraisal subscale of CERQ-SF, with scores from 2 to 10, higher scores meaning better outcomes	Baseline
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Rational and Irrational Beliefs	HABS-AV, with scores from 24 to 120, with higher scores meaning worse outcomes	Baseline
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Rumination	Focus on thought/rumination subscale of CERQ-SF, with scores from 2 to 10, higher scores meaning worse outcomes	Baseline
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)