Psychological Distress
Conditions
Keywords
mobile mental health, mHealth, attention bias training, psychological distress, digital CBT, emotion regulation, functional reappraisal, rumination
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.
Interventions
BEHAVIORALPsyPills
Prescribing personalized rational thinking strategies to change levels of dysfunctional emotionality.
BEHAVIORALOnline-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.
BEHAVIORALshamOCAT
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.
Sponsors
Universidad Complutense de Madrid
Babes-Bolyai University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants in all categories will be announced that they have received a mobile intervention aimed at distress reduction, without knowing the the rationale and specifics of each intervention. Outcomes will be assessed only by online questionnaires, so no assessor is involved.
Intervention model description
Participants will be randomly assigned to one of three conditions: 2 experimental conditions and an active control group.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 18-65 years old * Have access and able to use a smartphone
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 10 days | Post intervention (10 day) | DASS-21, with scores from 0 to 63, higher scores meaning worse outcomes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Positive Reappraisal | Baseline | 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 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 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 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 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 |
| 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 |
| 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 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 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 |
| 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 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 |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Experience Sampling Methods (ESM) questionnaire | During the intervention (3 times daily from day 1 to day 10) | 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 |
Countries
Romania
Outcome results
None listed