Study of the Efficacy of GGRO: a Novel Cognitive Training App (GGRO)

June 27, 2018 updated by: María Roncero, University of Valencia

Can Brief, Daily Training Using a Mobile Applications Help Change Maladaptive Beliefs? A Cross-over Randomized-control Study Evaluating the Efficacy of GGRO in Reducing Maladaptive Beliefs and Obsessive-compulsive Symptoms

The aim of the present study was to evaluate the efficacy of GGRO reducing OCD related maladaptive beliefs and OCD symptoms. Specifically, a randomized controlled trial with crossover design was carried out in non-clinical population to assess pre-post changes in levels of OCD-related maladaptive beliefs and OCD symptoms, including relationship OCD (ROCD) symptoms, self-esteem, and depressive symptoms following 15 days of using GGRO.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The implementation of Information and Communication Technologies in the treatment or prevention of OCD symptoms has been significantly lower compared to with its application in other anxiety disorders.

Recently, an exploratory study evaluated a brief, game-like, training exercise for challenging OCD-beliefs delivered via a mobile application platform named GGRO. However, more studies are needed to test the efficacy.

Study Type

Interventional

Enrollment (Actual)

97

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Being a Spanish at native level, and having a mobile device capable of installing the application GGRO

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immediate use GGRO Mobile App
The group starts using the GGRO Mobile App immediately after the first assessment (T1) for 15 days.
Device: GGRO Mobile App
GGRO was designed to challenge maladaptive beliefs that underlie common OCD symptoms (e.g., contamination, repugnant thoughts) as well as relationships obsessions. Users are presented with 'blocks' featuring statements such as "I take things as they come" or "Everything can end in a catastrophe". Users then have to respond to these statements by either pulling 'blocks' towards themselves (i.e., downwards) or throwing the blocks away from themselves (i.e., rejecting them upwards).
Active Comparator: Delayed use GGRO Mobile App
Delayed use GGRO Mobile App group started using the App 15 days after the first assessment (T2).
Device: GGRO Mobile App
GGRO was designed to challenge maladaptive beliefs that underlie common OCD symptoms (e.g., contamination, repugnant thoughts) as well as relationships obsessions. Users are presented with 'blocks' featuring statements such as "I take things as they come" or "Everything can end in a catastrophe". Users then have to respond to these statements by either pulling 'blocks' towards themselves (i.e., downwards) or throwing the blocks away from themselves (i.e., rejecting them upwards).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in obsessive beliefs
Time Frame: 15 days
Score change in obsessive compulsive maladaptive beliefs measured by the short form of the Obsessive Beliefs Questionnaire (OBQ-20). Total score is computed as a mean of the 20 items, ranging from 1 "disagree very much" to 7 "agree very much". Higher scores indicate the person has more obsessive beliefs.
15 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in obsessive compulsive symptoms
Time Frame: 15 days
Score change in obsessive-compulsive symptoms measured by the Obsessive Compulsive Inventory- Revised version (OCI-R). Total score is computed as a mean of the 18 items, ranging from 0 "not at all" to 4 "Extremely". Higher scores indicate a greater presence of obsessive-compulsive symptoms.
15 days
Change in depression symptoms
Time Frame: 15 days
Score change in depression symptoms measured by Depression, Anxiety and Stres Scale (DASS). The depression scale is composed by the mean of 7 items, ranging from 0 "did not apply to me at all" to 3 "applied to me very much, or most of the time". Higher scores indicate a greater presence of obsessive -compulsive symptoms.
15 days
Change in Self-Esteem
Time Frame: 15 days
Change in score of Single Ítem Self Esteem Scale (SISE). Self-Esteem is measured with this single item ranging from 1 "not very true for me" to 9 "very true for me". Higher scores indicates a higher Self-Esteem.
15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Valencia

Investigators

  • Principal Investigator: María Roncero, PhD, Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2016

Primary Completion (Actual)

June 10, 2017

Study Completion (Actual)

July 25, 2017

Study Registration Dates

First Submitted

June 12, 2018

First Submitted That Met QC Criteria

June 16, 2018

First Posted (Actual)

June 27, 2018

Study Record Updates

Last Update Posted (Actual)

June 29, 2018

Last Update Submitted That Met QC Criteria

June 27, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 706208

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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