Mood DisordersOASNCT04137471
Validation of the Ontological Addiction Scale
An observational study of Mood Disorders and Emotional Disorder, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Background: Bypassing a reductionist view of existing diagnostic categories, ontological addiction theory (OAT) is a new psychological model of human functioning and mental illness. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Mood Disorders, Emotional Disorder
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2019to 31 Mar 2021
- Phase
- Observational
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individual suffering from mood disorder (bipolar or unipolar) and/or emotional disorder (subjective complaint for difficulties to regulate emotions).
Who may be able to join
- An individual must fulfill all of the following criteria in order to be eligible for study enrollment:
- Aged between 18 and 70 years
- Suffering from mood disorder (bipolar or unipolar) and/or emotional disorder (subjective complaint for difficulties to regulate emotions).
- Being referred to the Therapeutic Center for Mood and Emotional Disorders for an 8-week-mindfulness-based-intervention
- Subjects must be able to attend all scheduled visits and to comply with all trial procedures
- Subjects must be covered by public health insurance
Who cannot join
- Subject unable to read or/and write
- Psychosis
- Subject who are in a dependency or employment with the sponsor or the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ontological Addiction Scale: Study Protocol for Scale Validation
Background:
Bypassing a reductionist view of existing diagnostic categories, ontological addiction theory (OAT) is a new psychological model of human functioning and mental illness. Ontological addiction is a maladaptive condition that stems from an erroneous belief in an inherently existing Self or "I", which is deemed to be the root of all suffering. Five experts from four different countries have created the Ontological Addiction Scale (OAS) to measure the condition and its impact on people's lives. The purpose of this study is to test this scale, evaluating levels of ontological addiction in individuals suffering from emotional or mood disorder, and assess its psychometric properties.
Read more
Methods:
This trial will be conducted in compliance with the COSMIN Guidelines. The investigators will collect data from 400 individuals, aged 18 to 70, suffering from emotional or mood disorder, referred to the Therapeutic Center for Mood and Emotional Disorders for an 8-week-mindfulness-based-intervention. Patients will complete the OAS at three time points: one month before the beginning of the therapy, within one week prior to the beginning of therapy, and one year after the end of the therapy. This scale will be completed in conjunction with other practice assessments relating to the psychotherapeutic program. The psychometric properties of the OAS will be assessed.
Discussion:
The Investigators aim to validate a scale assessing a psychological dimension as the root of all mental disorders. The present study may contribute to overcoming limitations of categorical understanding of mental disorders, thus moving toward a more encompassing dimensional comprehension. The scale is responsive to current thinking in modern psychiatry, and it is envisaged that its validation will deeply impact research and care perspectives
- Conditions
- Mood Disorders, Emotional Disorder
- Medical subject headings
- Mood Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of the Ontological Addiction Scale by measurement of its psychometric properties
Evaluation of the structural validity of the Ontological Addiction Scale (OAS)
Measured: one year after the end of the therapy
Secondary outcomes (18)
Measurement of the structural validity of the Ontological Addiction Scale by means of factor analysis (the technique of rotation of the main axes varimax will be used)
Evaluation of the structural validity of the Ontological Addiction Scale (OAS)
Measured: pre-treatment (first assessment) within one week prior to the beginning of therapy
Measurement of internal consistency of the Ontological Addiction Scale by a multitrait analysis (assessment of redundancy between items, validation of item consistency, assessment of item dimension intercorrelations)
Evaluation of internal consistency of the Ontological Addiction Scale (OAS)
Measured: pre-treatment (first assessment) within one week prior to the beginning of therapy
Measurement of reliability of the Ontological Addiction Scale by test-retest (degree to which the measurement is free from measurement error)
Evaluation of reliability of the Ontological Addiction Scale (OAS)
Measured: pre-treatment (first assessment) within one week prior to the beginning of therapy
Error measurement of the Ontological Addiction Scale by the calculation of the Strandard Error of the Mean.
Measurment error of the Ontological Addiction Scale (OAS)
Measured: pre-treatment (first assessment) within one week prior to the beginning of therapy
Content validity measurement of the Ontological Addiction Scale
Content validity measurement of the Addiction Scale (OAS) by content validity index (assessment of the simplicity and clarity of the questionnaire on a 4-point likert scale from not relevant to highly relevant. The answers will then be dichotomized as "not relevant" (score 1 or 2) or "relevant" (score 3 or 4)).
Measured: pre-treatment (first assessment) within one week prior to the beginning of therapy
Levels of concern about the mental representation that patients have of themselves (ontological addiction) by the Ontological Addiction Scale (by responding either "never", "rarely", "sometimes", "often", "always" to the 24 items)
Evaluation of ontological addiction by the ontological addiction scale
Measured: pre-treatment (first assessment) within one week prior to the beginning of therapy
Measurement of the structural validity of the Ontological Addiction Scale by means of factor analysis (the technique of rotation of the main axes varimax will be used)
Evaluation of the structural validity of the Ontological Addiction Scale (OAS)
Measured: post therapy (second assessment) within the week following completion of therapy
Measurement of internal consistency of the Ontological Addiction Scale by a multitrait analysis (assessment of redundancy between items, validation of item consistency, assessment of item dimension intercorrelations)
Evaluation of internal consistency of the Ontological Addiction Scale (OAS)
Measured: post therapy (second assessment) within the week following completion of therapy
Measurement of reliability of the Ontological Addiction Scale by test-retest (degree to which the measurement is free from measurement error)
Evaluation of reliability of the Ontological Addiction Scale (OAS)
Measured: post therapy (second assessment) within the week following completion of therapy
Error measurement of the Ontological Addiction Scale by the calculation of the Strandard Error of the Mean
Measurment error of the Ontological Addiction Scale (OAS)
Measured: post therapy (second assessment) within the week following completion of therapy
Content validity measurement of the Ontological Addiction Scale
Content validity measurement of the Addiction Scale (OAS) by content validity index (assessment of the simplicity and clarity of the questionnaire on a 4-point likert scale from not relevant to highly relevant). The answers will then be dichotomized as "not relevant" (score 1 or 2) or "relevant" (score 3 or 4)).
Measured: post therapy (second assessment) within the week following completion of therapy
Levels of concern about the mental representation that patients have of themselves (ontological addiction) by the Ontological Addiction Scale (by responding either "never", "rarely", "sometimes", "often", "always" to the 24 items)
Evaluation of ontological addiction by the ontological addiction scale
Measured: post therapy (second assessment) within the week following completion of therapy
Measurement of the structural validity of the Ontological Addiction Scale by means of factor analysis (the technique of rotation of the main axes varimax will be used)
Evaluation of the structural validity of the Ontological Addiction Scale (OAS)
Measured: one year after the end of the therapy.
Measurement of internal consistency of the Ontological Addiction Scale by a multitrait analysis (assessment of redundancy between items, validation of item consistency, assessment of item dimension intercorrelations)
one year after the end of the therapy.
Measured: Evaluation of internal consistency of the Ontological Addiction Scale (OAS)
Measurement of reliability of the Ontological Addiction Scale by test-retest (degree to which the measurement is free from measurement error)
Evaluation of reliability of the Ontological Addiction Scale (OAS)
Measured: one year after the end of the therapy.
Error measurement of the Ontological Addiction Scale by the calculation of the Strandard Error of the Mean
Measurment error of the Ontological Addiction Scale (OAS)
Measured: one year after the end of the therapy.
Content validity measurement of the Ontological Addiction Scale
Content validity measurement of the Addiction Scale (OAS) by content validity index (assessment of the simplicity and clarity of the questionnaire on a 4-point likert scale from not relevant to highly relevant). The answers will then be dichotomized as "not relevant" (score 1 or 2) or "relevant" (score 3 or 4)).
Measured: one year after the end of the therapy.
Levels of concern about the mental representation that patients have of themselves (ontological addiction) by the Ontological Addiction Scale (by responding either "never", "rarely", "sometimes", "often", "always" to the 24 items)
Evaluation of ontological addiction by the ontological addiction scale
Measured: one year after the end of the therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2019
- Study start1 Nov 2019
- Primary completion1 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mood DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- DEBORAH DUCASSE, MD, Principal investigator, University Hospitals of Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04137471
- Sponsor's protocol ID
- RECHMPL19_0466
- Acronym
- OAS
- Status last verified
- Oct 2021
- First submitted
- 30 Sep 2019
- Last updated
- 25 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Publications
Ducasse D, Leurent M, Picot MC, Aouinti S, Brand-Arpon V, Courtet P, Barrows P, Shonin E, Sapthiang S, Olie E, Van Gordon W. French Translation and Validation of the Ontological Addiction Scale (OAS). Int J Environ Res Public Health. 2025 Mar 27;22(4):511. doi: 10.3390/ijerph22040511.
PubMed 40283737
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ontological Addiction Scale: Study Protocol for Scale Validation
- ClinicalTrials.gov ID
- NCT04137471
- Acronym / sponsor ID
- OAS / RECHMPL19_0466
- Conditions
- Mood Disorders, Emotional Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 24 Oct 2019 (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.
Background:
Bypassing a reductionist view of existing diagnostic categories, ontological addiction theory (OAT) is a new psychological model of human functioning and mental illness. Ontological addiction is a maladaptive condition that stems from an erroneous belief in an inherently existing Self or "I", which is deemed to be the root of all suffering. Five experts from four different countries have created the Ontological Addiction Scale (OAS) to measure the condition and its impact on people's lives. The purpose of this study is to test this scale, evaluating levels of ontological addiction in individuals suffering from emotional or mood disorder, and assess its psychometric properties.
Methods:
This trial will be conducted in compliance with the COSMIN Guidelines. The investigators will collect data from 400 individuals, aged 18 to 70, suffering from emotional or mood disorder, referred to the Therapeutic Center for Mood and Emotional Disorders for an 8-week-mindfulness-based-intervention. Patients will complete the OAS at three time points: one month before the beginning of the therapy, within one week prior to the beginning of therapy, and one year after the end of the therapy. This scale will be completed in conjunction with other practice assessments relating to the psychotherapeutic program. The psychometric properties of the OAS will be assessed.
Discussion:
The Investigators aim to validate a scale assessing a psychological dimension as the root of all mental disorders. The present study may contribute to overcoming limitations of categorical understanding of mental disorders, thus moving toward a more encompassing dimensional comprehension. The scale is responsive to current thinking in modern psychiatry, and it is envisaged that its validation will deeply impact research and care perspectives
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individual suffering from mood disorder (bipolar or unipolar) and/or emotional disorder (subjective complaint for difficulties to regulate emotions).
Key inclusion criteria (6 listed)
- An individual must fulfill all of the following criteria in order to be eligible for study enrollment:
- Aged between 18 and 70 years
- Suffering from mood disorder (bipolar or unipolar) and/or emotional disorder (subjective complaint for difficulties to regulate emotions).
- Being referred to the Therapeutic Center for Mood and Emotional Disorders for an 8-week-mindfulness-based-intervention
- Subjects must be able to attend all scheduled visits and to comply with all trial procedures
Key exclusion criteria (3 listed)
- Subject unable to read or/and write
- Psychosis
- Subject who are in a dependency or employment with the sponsor or the investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Validation of the Ontological Addiction Scale by measurement of its psychometric properties
Time frame: one year after the end of the therapy
Evaluation of the structural validity of the Ontological Addiction Scale (OAS)
18 secondary outcomes
Measurement of the structural validity of the Ontological Addiction Scale by means of factor analysis (the technique of rotation of the main axes varimax will be used)
Time frame: pre-treatment (first assessment) within one week prior to the beginning of therapy
Measurement of internal consistency of the Ontological Addiction Scale by a multitrait analysis (assessment of redundancy between items, validation of item consistency, assessment of item dimension intercorrelations)
Time frame: pre-treatment (first assessment) within one week prior to the beginning of therapy
Measurement of reliability of the Ontological Addiction Scale by test-retest (degree to which the measurement is free from measurement error)
Time frame: pre-treatment (first assessment) within one week prior to the beginning of therapy
Error measurement of the Ontological Addiction Scale by the calculation of the Strandard Error of the Mean.
Time frame: pre-treatment (first assessment) within one week prior to the beginning of therapy
Content validity measurement of the Ontological Addiction Scale
Time frame: pre-treatment (first assessment) within one week prior to the beginning of therapy
Levels of concern about the mental representation that patients have of themselves (ontological addiction) by the Ontological Addiction Scale (by responding either "never", "rarely", "sometimes", "often", "always" to the 24 items)
Time frame: pre-treatment (first assessment) within one week prior to the beginning of therapy
Measurement of the structural validity of the Ontological Addiction Scale by means of factor analysis (the technique of rotation of the main axes varimax will be used)
Time frame: post therapy (second assessment) within the week following completion of therapy
Measurement of internal consistency of the Ontological Addiction Scale by a multitrait analysis (assessment of redundancy between items, validation of item consistency, assessment of item dimension intercorrelations)
Time frame: post therapy (second assessment) within the week following completion of therapy
Measurement of reliability of the Ontological Addiction Scale by test-retest (degree to which the measurement is free from measurement error)
Time frame: post therapy (second assessment) within the week following completion of therapy
Error measurement of the Ontological Addiction Scale by the calculation of the Strandard Error of the Mean
Time frame: post therapy (second assessment) within the week following completion of therapy
Content validity measurement of the Ontological Addiction Scale
Time frame: post therapy (second assessment) within the week following completion of therapy
Levels of concern about the mental representation that patients have of themselves (ontological addiction) by the Ontological Addiction Scale (by responding either "never", "rarely", "sometimes", "often", "always" to the 24 items)
Time frame: post therapy (second assessment) within the week following completion of therapy
Measurement of the structural validity of the Ontological Addiction Scale by means of factor analysis (the technique of rotation of the main axes varimax will be used)
Time frame: one year after the end of the therapy.
Measurement of internal consistency of the Ontological Addiction Scale by a multitrait analysis (assessment of redundancy between items, validation of item consistency, assessment of item dimension intercorrelations)
Time frame: Evaluation of internal consistency of the Ontological Addiction Scale (OAS)
Measurement of reliability of the Ontological Addiction Scale by test-retest (degree to which the measurement is free from measurement error)
Time frame: one year after the end of the therapy.
Error measurement of the Ontological Addiction Scale by the calculation of the Strandard Error of the Mean
Time frame: one year after the end of the therapy.
Content validity measurement of the Ontological Addiction Scale
Time frame: one year after the end of the therapy.
Levels of concern about the mental representation that patients have of themselves (ontological addiction) by the Ontological Addiction Scale (by responding either "never", "rarely", "sometimes", "often", "always" to the 24 items)
Time frame: one year after the end of the therapy.
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 25 Oct 2021.
- Derived from this study: PubMed 40283737Ducasse D, Leurent M, Picot MC, Aouinti S, Brand-Arpon V, Courtet P, Barrows P, Shonin E, Sapthiang S, Olie E, Van Gordon W. French Translation and Validation of the Ontological Addiction Scale (OAS). Int J Environ Res Public Health. 2025 Mar 27;22(4):511. doi: 10.3390/ijerph22040511.
- Individual participant dataSharing planned: Undecided. NC
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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.
DEBORAH DUCASSE, MD principal investigator
University Hospitals of Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mood Disorders and Emotional Disorder, run by University Hospital, Montpellier at 1 site in France.
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 6 inclusion and 3 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 25 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Validation of the Ontological Addiction Scale by measurement of its psychometric properties (time frame: one year after the end of the therapy). 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 NCT04137471, which also lists 1 linked publication.
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 25 Oct 2021; AzTrials last refreshed its copy on 2 Nov 2026.