---
title: Validation of the Ontological Addiction Scale
nct_id: NCT04137471
overall_status: COMPLETED
sponsor: University Hospital, Montpellier
study_type: OBSERVATIONAL
primary_condition: Mood Disorders
countries: France
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04137471.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04137471"
ct_last_update_post_date: 2021-10-25
last_seen_at: "2026-05-12T06:34:04.713Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Validation of the Ontological Addiction Scale

**Official Title:** Ontological Addiction Scale: Study Protocol for Scale Validation

**NCT ID:** [NCT04137471](https://clinicaltrials.gov/study/NCT04137471)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 400
- **Lead Sponsor:** University Hospital, Montpellier
- **Conditions:** Mood Disorders, Emotional Disorder
- **Start Date:** 2019-11-01
- **Completion Date:** 2021-03-31
- **CT.gov Last Update:** 2021-10-25

## 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

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 70 Years
- **Sex:** ALL
- **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
```

## Primary Outcomes

- **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

- **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.)_

## Locations (1)

- Uh Montpellier, Montpellier, France

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.uh montpellier|montpellier||france` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT04137471*  
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