NCT03571464

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
97

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2016

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

September 25, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 27, 2018

Completed
Last Updated

June 29, 2018

Status Verified

June 1, 2018

Enrollment Period

9 months

First QC Date

June 12, 2018

Last Update Submit

June 27, 2018

Conditions

Obsessive Thoughts

Keywords

obsessive compulsive disordercognitive therapymaladaptive beliefsmobile app

Outcome Measures

Primary Outcomes (1)

  • Change in obsessive beliefs

    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 Outcomes (3)

  • Change in obsessive compulsive symptoms

    15 days

  • Change in depression symptoms

    15 days

  • Change in Self-Esteem

    15 days

Study Arms (2)

Immediate use GGRO Mobile App

EXPERIMENTAL

The group starts using the GGRO Mobile App immediately after the first assessment (T1) for 15 days.

Device: GGRO Mobile App

Delayed use GGRO Mobile App

ACTIVE COMPARATOR

Delayed use GGRO Mobile App group started using the App 15 days after the first assessment (T2).

Device: GGRO Mobile App

Interventions

GGRO Mobile AppDEVICE

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).

Delayed use GGRO Mobile AppImmediate use GGRO Mobile App

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Roncero M, Belloch A, Doron G. A novel approach to challenging OCD related beliefs using a mobile-app: An exploratory study. J Behav Ther Exp Psychiatry. 2018 Jun;59:157-160. doi: 10.1016/j.jbtep.2018.01.008. Epub 2018 Feb 2.

    PMID: 29425951BACKGROUND

  • Roncero M, Belloch A, Doron G. Can Brief, Daily Training Using a Mobile App Help Change Maladaptive Beliefs? Crossover Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 Feb 13;7(2):e11443. doi: 10.2196/11443.

    PMID: 30758294DERIVED

Related Links

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Study Officials

  • María Roncero, PhD

    Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: All participants were requested to complete web-based assessment, with questionnaires relating to maladaptive beliefs, mood and OC symptoms at baseline (T1), 15 days following baseline (T2) and 30 days following baseline (T3). Participants in Immediate use GGRO group started using the app at baseline and continued using the app for 15 consecutive days. They were then requested to stop using the app until T3. Participants in the Delayed use GGRO group were requested to wait for 15 days and only then start using the app (cross-over) for 15 consecutive days.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 12, 2018

First Posted

June 27, 2018

Study Start

September 25, 2016

Primary Completion

June 10, 2017

Study Completion

July 25, 2017

Last Updated

June 29, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share