Psychological Mobile Interventions to Reduce Distress

NCT ID: NCT05294809

Last Updated: 2025-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-12

Study Completion Date

2023-10-29

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.

Conditions

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Psychological Distress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomly assigned to one of three conditions: 2 experimental conditions and an active control group.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
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.

Study Groups

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PsyPills

The participants randomized in this condition will receive the mobile health application "PsyPills".

Group Type EXPERIMENTAL

PsyPills

Intervention Type BEHAVIORAL

Prescribing personalized rational thinking strategies to change levels of dysfunctional emotionality.

OCAT

The participants randomized in this condition will receive the mobile health application "OCAT".

Group Type EXPERIMENTAL

Online-Contingent Attention Training, OCAT

Intervention Type BEHAVIORAL

Facilitating the disengagement from negative content and engagement of positive one of personally relevant information by providing instruction and feedback on performance.

OCAT sham

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.

Group Type PLACEBO_COMPARATOR

shamOCAT

Intervention Type BEHAVIORAL

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.

Interventions

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PsyPills

Prescribing personalized rational thinking strategies to change levels of dysfunctional emotionality.

Intervention Type BEHAVIORAL

Online-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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad Complutense de Madrid

OTHER

Sponsor Role collaborator

Babes-Bolyai University

OTHER

Sponsor Role lead

Responsible Party

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Sîrbu Vasile

PhD student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Oana David, Dr.

Role: STUDY_DIRECTOR

Babes-Bolyai University

Locations

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Babes-Bolyai University

Cluj-Napoca, , Romania

Site Status

Countries

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Romania

Other Identifiers

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13.912 / 29.10.2021

Identifier Type: -

Identifier Source: org_study_id

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