Psychological Mobile Interventions to Reduce Distress

Babes-Bolyai University

Status: Completed

Conditions: Psychological Distress

Treatments: Behavioral: shamOCAT; Behavioral: PsyPills; Behavioral: Online-Contingent Attention Training, OCAT

Study type: Interventional

Funder types: Other

Identifiers

NCT05294809

13.912 / 29.10.2021

Details and patient eligibility

About

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).

Full 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.

Enrollment: 450 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

450 participants in 3 patient groups, including a placebo group

PsyPills

Experimental group

Description:

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

Treatment:

Behavioral: PsyPills

OCAT

Experimental group

Description:

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

Treatment:

Behavioral: Online-Contingent Attention Training, OCAT

OCAT sham

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: shamOCAT