Psychological Mobile Interventions to Reduce Distress
- Conditions
- Psychological Distress
- Interventions
- Behavioral: PsyPillsBehavioral: shamOCATBehavioral: Online-Contingent Attention Training, OCAT
- Registration Number
- NCT05294809
- Lead Sponsor
- Babes-Bolyai University
- Brief 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).
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 450
- 18-65 years old
- Have access and able to use a smartphone
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PsyPills PsyPills The participants randomized in this condition will receive the mobile health application "PsyPills". OCAT sham 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. OCAT Online-Contingent Attention Training, OCAT The participants randomized in this condition will receive the mobile health application "OCAT".
- Primary Outcome Measures
Name Time Method Depressive, Anxiety, and Stress Symptoms 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 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 1 month Follow-up (1 month) DASS-21, with scores from 0 to 63, higher scores meaning worse outcomes
Change from Baseline Depressive, Anxiety, and Stress Symptoms at 10 days Post intervention (10 day) DASS-21, with scores from 0 to 63, higher scores meaning worse outcomes
- Secondary Outcome Measures
Name Time Method Positive Reappraisal Baseline Positive reappraisal subscale of CERQ-SF, with scores from 2 to 10, higher scores meaning better outcomes
Functional Reappraisal 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
Change from Baseline Functional Reappraisal at 5 days 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
Change from Baseline Functional Reappraisal at 10 days 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
Change from Baseline Functional Reappraisal at 1 month 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
Change from Baseline Rational and Irrational Beliefs at 5 days Mid of intervention (5 days) HABS-AV, with scores from 24 to 120, with higher scores meaning worse outcomes
Change from Baseline Positive Reappraisal at 5 days Mid of intervention (5 days) Positive reappraisal subscale of CERQ-SF, with scores from 2 to 10, higher scores meaning better outcomes
Change from Baseline Positive Reappraisal at 10 days Post intervention (10 days) Positive reappraisal subscale of CERQ-SF, with scores from 2 to 10, higher scores meaning better outcomes
Change from Baseline Positive Reappraisal at 1 month Follow-up (1 month) Positive reappraisal subscale of CERQ-SF, with scores from 2 to 10, higher scores meaning better outcomes
Rational and Irrational Beliefs Baseline HABS-AV, with scores from 24 to 120, with higher scores meaning worse outcomes
Change from Baseline Rumination at 10 days Post intervention (10 days) Focus on thought/rumination subscale of CERQ-SF, with scores from 2 to 10, higher scores meaning worse outcomes
Change from Baseline Rumination at 1 month Follow-up (1 month) Focus on thought/rumination subscale of CERQ-SF, with scores from 2 to 10, higher scores meaning worse outcomes
Change from Baseline Rational and Irrational Beliefs at 10 days Post intervention (10 days) HABS-AV, with scores from 24 to 120, with higher scores meaning worse outcomes
Change from Baseline Attention Bias at 5 days 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
Change from Baseline Rational and Irrational Beliefs at 1 month Follow-up (1 month) HABS-AV, with scores from 24 to 120, with higher scores meaning worse outcomes
Rumination Baseline Focus on thought/rumination subscale of CERQ-SF, with scores from 2 to 10, higher scores meaning worse outcomes
Change from Baseline Rumination at 5 days Mid of intervention (5 days) Focus on thought/rumination subscale of CERQ-SF, with scores from 2 to 10, higher scores meaning worse outcomes
Change from Baseline Functional and Dysfunctional Emotions at 5 days 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
Change from Baseline Functional and Dysfunctional Emotions at 10 days 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
Change from Baseline Functional and Dysfunctional Emotions at 1 month 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
Attention bias 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
Change from Baseline Attention Bias at 10 days 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
Change from Baseline Attention Bias at 1 month 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
Functional and Dysfunctional Emotions 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
Trial Locations
- Locations (1)
Babes-Bolyai University
🇷🇴Cluj-Napoca, Romania