NCT05294809

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2022

Completed
29 days until next milestone

First Posted

Study publicly available on registry

March 24, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

June 12, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 29, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2023

Completed
Last Updated

February 7, 2025

Status Verified

February 1, 2025

Enrollment Period

1.4 years

First QC Date

February 23, 2022

Last Update Submit

February 5, 2025

Conditions

Psychological Distress

Keywords

mobile mental healthmHealthattention bias trainingpsychological distressdigital CBTemotion regulationfunctional reappraisalrumination

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (24)

  • Functional Reappraisal

    Baseline

  • Change from Baseline Functional Reappraisal at 5 days

    Mid of intervention (5 days)

  • Change from Baseline Functional Reappraisal at 10 days

    Post intervention (10 day)

  • Change from Baseline Functional Reappraisal at 1 month

    Follow-up (1 month)

  • Positive Reappraisal

    Baseline

  • +19 more secondary outcomes

Other Outcomes (1)

  • Experience Sampling Methods (ESM) questionnaire

    During the intervention (3 times daily from day 1 to day 10)

Study Arms (3)

PsyPills

EXPERIMENTAL

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

Behavioral: PsyPills

OCAT

EXPERIMENTAL

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

Behavioral: Online-Contingent Attention Training, OCAT

OCAT sham

PLACEBO COMPARATOR

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

Interventions

PsyPillsBEHAVIORAL

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

PsyPills
Online-Contingent Attention Training, OCATBEHAVIORAL

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

OCAT
shamOCATBEHAVIORAL

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.

OCAT sham

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old
  • Have access and able to use a smartphone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Babes-Bolyai University

Cluj-Napoca, 400084, Romania

Location

MeSH Terms

Conditions

Emotional RegulationRumination Syndrome

Condition Hierarchy (Ancestors)

Self-ControlSocial BehaviorBehaviorGastrointestinal DiseasesDigestive System DiseasesFeeding and Eating DisordersMental Disorders

Study Officials

  • Oana David, Dr.

    Babes-Bolyai University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to one of three conditions: 2 experimental conditions and an active control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

February 23, 2022

First Posted

March 24, 2022

Study Start

June 12, 2022

Primary Completion

October 29, 2023

Study Completion

October 29, 2023

Last Updated

February 7, 2025

Record last verified: 2025-02

Locations

RO(1)