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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
450
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.
Babes-Bolyai University
Cluj-Napoca, Romania
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
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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)