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NCT Number: NCT04137471

Validation of the Ontological Addiction Scale

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

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Key information

Conditions

Mood Disorders Emotional Disorder Mental Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Uh Montpellier

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Subject unable to read or/and write
  • Psychosis
  • Subject who are in a dependency or employment with the sponsor or the investigator

Treatment and study plan

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

    Evaluation of the structural validity of the Ontological Addiction Scale (OAS)

  2. 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

    Evaluation of internal consistency of the Ontological Addiction Scale (OAS)

  3. 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

    Evaluation of reliability of the Ontological Addiction Scale (OAS)

  4. 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

    Measurment error of the Ontological Addiction Scale (OAS)

  5. Content validity measurement of the Ontological Addiction Scale

    Time frame: pre-treatment (first assessment) within one week prior to the beginning of therapy

    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)).

  6. 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

    Evaluation of ontological addiction by the ontological addiction scale

  7. 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

    Evaluation of the structural validity of the Ontological Addiction Scale (OAS)

  8. 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

    Evaluation of internal consistency of the Ontological Addiction Scale (OAS)

  9. 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

    Evaluation of reliability of the Ontological Addiction Scale (OAS)

  10. 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

    Measurment error of the Ontological Addiction Scale (OAS)

  11. Content validity measurement of the Ontological Addiction Scale

    Time frame: post therapy (second assessment) within the week following completion of therapy

    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)).

  12. 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

    Evaluation of ontological addiction by the ontological addiction scale

  13. 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.

    Evaluation of the structural validity of the Ontological Addiction Scale (OAS)

  14. 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)

    one year after the end of the therapy.

  15. 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.

    Evaluation of reliability of the Ontological Addiction Scale (OAS)

  16. 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.

    Measurment error of the Ontological Addiction Scale (OAS)

  17. Content validity measurement of the Ontological Addiction Scale

    Time frame: one year after the end of the therapy.

    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)).

  18. 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.

    Evaluation of ontological addiction by the ontological addiction scale

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Ontological Addiction Scale: Study Protocol for Scale Validation

Acronym: OAS

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 24, 2019
Registry last updated
Oct 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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