OAS: Validation of the Ontological Addiction Scale

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Completed
CT.gov ID
NCT04137471
Collaborator
(none)
400
1
17
23.6

Study Details

Study Description

Brief 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. 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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    400 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Ontological Addiction Scale: Study Protocol for Scale Validation
    Actual Study Start Date :
    Nov 1, 2019
    Actual Primary Completion Date :
    Mar 1, 2021
    Actual Study Completion Date :
    Mar 31, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Validation of the Ontological Addiction Scale by measurement of its psychometric properties [one year after the end of the therapy]

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

    Secondary Outcome Measures

    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) [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) [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) [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. [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 [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) [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) [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) [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) [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 [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 [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) [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) [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) [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) [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 [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 [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) [one year after the end of the therapy.]

      Evaluation of ontological addiction by the ontological addiction scale

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Uh Montpellier Montpellier France 34295

    Sponsors and Collaborators

    • University Hospital, Montpellier

    Investigators

    • Principal Investigator: DEBORAH DUCASSE, MD, University Hospitals of Montpellier

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Montpellier
    ClinicalTrials.gov Identifier:
    NCT04137471
    Other Study ID Numbers:
    • RECHMPL19_0466
    First Posted:
    Oct 24, 2019
    Last Update Posted:
    Oct 25, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 25, 2021