Psychological Mobile Interventions to Reduce Distress

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effectiveness and Mechanisms of Change of Two Mobile Psychological Interventions in Reducing Depressive, Anxiety and Stress Symptoms: PsyPills and Online-Contingent Attention Training (OCAT)

Conditions
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Psychological Distress

Intervention / Treatment
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* Behavioral: PsyPills
* Behavioral: Online-Contingent Attention Training, OCAT
* Behavioral: shamOCAT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-65 years old Have access and able to use a smartphone

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomly assigned to one of three conditions: 2 experimental conditions and an active control group.
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mHealth, mobile mental health, attention bias training, psychological distress, digital CBT, emotion regulation, functional reappraisal, rumination