Clinical trial NCT05294809: Psychological Mobile Interventions to Reduce Distress
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychological Distress
Keywords: mobile mental health
mHealth
attention bias training
psychological distress
digital CBT
emotion regulation
functional reappraisal
rumination
Lead sponsor: Babes-Bolyai University
Sponsor class: OTHER
Collaborators: name: Universidad Complutense de Madrid
First posted: 2022-03-24
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to one of three conditions: 2 experimental conditions and an active control group.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 18-65 years old
* Have access and able to use a smartphone

Primary outcomes:
measure: Depressive, Anxiety, and Stress Symptoms
timeFrame: Baseline
measure: Change from Baseline Depressive, Anxiety, and Stress Symptoms at 5 days
timeFrame: Mid of intervention (5 days)
measure: Change from Baseline Depressive, Anxiety, and Stress Symptoms at 10 days
timeFrame: Post intervention (10 day)
measure: Change from Baseline Depressive, Anxiety, and Stress Symptoms at 1 month
timeFrame: Follow-up (1 month)
Secondary outcomes:
measure: Functional Reappraisal
timeFrame: Baseline
measure: Change from Baseline Functional Reappraisal at 5 days
timeFrame: Mid of intervention (5 days)
measure: Change from Baseline Functional Reappraisal at 10 days
timeFrame: Post intervention (10 day)
measure: Change from Baseline Functional Reappraisal at 1 month
timeFrame: Follow-up (1 month)
measure: Positive Reappraisal
timeFrame: Baseline
measure: Change from Baseline Positive Reappraisal at 5 days
timeFrame: Mid of intervention (5 days)
measure: Change from Baseline Positive Reappraisal at 10 days
timeFrame: Post intervention (10 days)
measure: Change from Baseline Positive Reappraisal at 1 month
timeFrame: Follow-up (1 month)
measure: Rational and Irrational Beliefs
timeFrame: Baseline
measure: Change from Baseline Rational and Irrational Beliefs at 5 days
timeFrame: Mid of intervention (5 days)
measure: Change from Baseline Rational and Irrational Beliefs at 10 days
timeFrame: Post intervention (10 days)
measure: Change from Baseline Rational and Irrational Beliefs at 1 month
timeFrame: Follow-up (1 month)
measure: Rumination
timeFrame: Baseline
measure: Change from Baseline Rumination at 5 days
timeFrame: Mid of intervention (5 days)
measure: Change from Baseline Rumination at 10 days
timeFrame: Post intervention (10 days)
measure: Change from Baseline Rumination at 1 month
timeFrame: Follow-up (1 month)
measure: Functional and Dysfunctional Emotions
timeFrame: Baseline
measure: Change from Baseline Functional and Dysfunctional Emotions at 5 days
timeFrame: Mid of intervention (5 days)
measure: Change from Baseline Functional and Dysfunctional Emotions at 10 days
timeFrame: Post intervention (10 days)
measure: Change from Baseline Functional and Dysfunctional Emotions at 1 month
timeFrame: Follow-up (1 month)
measure: Attention bias
timeFrame: Baseline
measure: Change from Baseline Attention Bias at 5 days
timeFrame: Mid of intervention (5 days)
measure: Change from Baseline Attention Bias at 10 days
timeFrame: Post intervention (10 days)
measure: Change from Baseline Attention Bias at 1 month
timeFrame: Follow-up (1 month)
Other outcomes:
measure: Experience Sampling Methods (ESM) questionnaire
timeFrame: During the intervention (3 times daily from day 1 to day 10)
Locations:
city: Cluj-Napoca
country: Romania
facility: Babes-Bolyai University
Study officials:
affiliation: Babes-Bolyai University
name: Oana David, Dr.
role: STUDY_DIRECTOR
References: