Obsessive ThoughtsGGRONCT03571464
Study of the Efficacy of GGRO: a Novel Cognitive Training App
A study testing GGRO Mobile App in people with Obsessive Thoughts, run by University of Valencia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obsessive Thoughts
- What is being tested?
- GGRO Mobile App
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- No sites listed yet
- Study dates
- 25 Sep 2016to 25 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being a Spanish at native level, and having a mobile device capable of installing the application GGRO
Who cannot join
- None
About this study
Official title: 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.
Read the 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.
- Conditions
- Obsessive Thoughts
- Being tested
- GGRO Mobile App
- Keywords
- obsessive compulsive disorder, cognitive therapy, maladaptive beliefs, mobile app
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| Immediate use GGRO Mobile App | Experimental | The group starts using the GGRO Mobile App immediately after the first assessment (T1) for 15 days. Receives: 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). Receives: Device: GGRO Mobile App |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 days
Secondary outcomes (3)
Change in obsessive compulsive symptoms
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.
Measured: 15 days
Change in depression symptoms
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.
Measured: 15 days
Change in Self-Esteem
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.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2018
- Study start25 Sep 2016
- Primary completion10 Jun 2017
- Study completion25 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obsessive ThoughtsStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María Roncero, University of Valencia
- Investigators
- María Roncero, PhD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03571464
- Sponsor's protocol ID
- 706208
- Acronym
- GGRO
- Status last verified
- Jun 2018
- First submitted
- 12 Jun 2018
- Last updated
- 29 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29425951Roncero 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.
PubMed 30758294
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03571464
- Acronym / sponsor ID
- GGRO / 706208
- Conditions
- Obsessive Thoughts
- Keywords
- obsessive compulsive disorder, cognitive therapy, maladaptive beliefs, mobile app
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 25 Sep 2016 (actual)
- Primary completion
- 10 Jun 2017 (actual)
- Study completion
- 25 Jul 2017 (actual)
- First posted
- 27 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Immediate use GGRO Mobile App | Experimental | Device: GGRO Mobile AppThe group starts using the GGRO Mobile App immediately after the first assessment (T1) for 15 days. |
| Delayed use GGRO Mobile App | Active comparator | Device: GGRO Mobile AppDelayed use GGRO Mobile App group started using the App 15 days after the first assessment (T2). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Being a Spanish at native level, and having a mobile device capable of installing the application GGRO
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GGRO Mobile AppGGRO 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). | Device | Delayed use GGRO Mobile App, Immediate use GGRO Mobile App |
Primary outcome
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.
3 secondary outcomes
Change in obsessive compulsive symptoms
Time frame: 15 days
Change in depression symptoms
Time frame: 15 days
Change in Self-Esteem
Time frame: 15 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2018.
- Background: PubMed 29425951Roncero 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.
- Derived from this study: PubMed 30758294Roncero 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.
- Individual participant dataSharing planned: No
Related trials for Obsessive Thoughts
Active, not recruiting
Cortical Stimulation to Treat Obsessive Compulsive Disorder
Obsessive-Compulsive Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
María Roncero, PhD principal investigator
Professor
Questions about this trial
What is this clinical trial studying?
A study testing GGRO Mobile App in people with Obsessive Thoughts, run by University of Valencia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in obsessive beliefs (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03571464, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2018.