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Recruiting NCT07399626

Adaptation and Validation of the Hypomanic Personality Scale (HPS-6) to Romanian

Phase I / Phase II Interventional Bipolar Disorder (BD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hypomanic Personality Scale - 6.
Who it may be relevant to
Registry conditions: Bipolar Disorder (BD). Basic parameters: 18 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Romania
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Adaptation and Validation of the Hypomanic Personality Scale (HPS-6) to Romanian.

Overview

The HPS-6 (Hypomanic Personality Scale, 6 item version) could prove to be a valuable candidate for screening measures of high risk individuals. In the following study, we aim to validate and adapt the HPS-6 for the Romanian population.

Detailed description

Bipolar disorder (BD) is a chronic, debilitating disorder, affecting approximately 2.4% of the global population. Inaccurate diagnosis leads to inappropriate management of the disorder as well as unsuitable medication prescription. On average, it can take a BD individual 5 to 10 years to receive an accurate diagnosis and receive competent treatment. Across the European Union (EU) Romania has the lowest prevalence of psychiatric disorders, 14.3%. Unfortunately, these positive estimates are related to the severe stigma linked to poor mental health in the Romanian population. Although the average length of a psychiatric stay in the EU spans across 24.3 days, Romania's average is 17.7. Poor infrastructure and lack of personnel in the Romanian healthcare system might be partially responsible. Therefore, brief, validated screening measures for complex diagnoses are necessary.

Interventions

  • Diagnostic test Hypomanic Personality Scale - 6
    A brief instrument, such as the HPS-6, with high specificity can help navigate specialists towards a correct diagnosis or recognize risk patterns in Bipolar Spectrum Individuals.

Primary outcome measures

  • Hypomanic Personality Scale - 6 (HPS-6) [Time frame: Baseline and one month later for re-test measures (in order to account for test-retest reliability)]
  • Mood Disorder Questionnaire (MDQ) [Time frame: Baseline]
  • Behavioral Inhibition System / Behavioral Activation System scales (BISBAS) [Time frame: One month after Baseline]
  • Positive and Negative Affect Schedule (PANAS) [Time frame: One month after Baseline.]
  • Negative Urgency, Premeditation, Perseverance, Sensations Seeking, and Positive Urgency - Impulsive Behavior Scale (UPPS-P) [Time frame: One month after Baseline]
  • Affective Lability Scale - Short Form (ALS-18) [Time frame: One month after Baseline]
  • Positive Overgeneralization (POG) [Time frame: One month after Baseline.]
  • Altman Self-Rating Mania Scale (ASRM) [Time frame: Baseline]
  • Food Neophobia Scale (FNS) [Time frame: Baseline]
  • Patient Health Questionnaire-9 (PHQ-9) [Time frame: Baseline]
Secondary outcome measures (2)
  • Psychiatric Diagnostic Screening Questionnaire (PDSQ) [Time frame: Baseline]
  • Suicide Behavior Questionnaire-Revised (SBQ-R) [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

  • 18-50 years of age
  • Not at high risk of suicide (current)
  • Not high SUDs / AUDs (current)
  • Native Romanian speaker
  • Cognitive abilities intact (reading comprehension of items)

Exclusion criteria

  • High risk of suicide (current)
  • High SUDs / AUDs (current)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Sequential
Masking
Triple blind
Primary purpose
Screening

Study locations

Romania · 1 center
  • Babeș-Bolyai University — Cluj-Napoca

Publications

  • Wang HR, Woo YS, Ahn HS, Ahn IM, Kim HJ, Bahk WM. THE VALIDITY OF THE MOOD DISORDER QUESTIONNAIRE FOR SCREENING BIPOLAR DISORDER: A META-ANALYSIS. Depress Anxiety. 2015 Jul;32(7):527-38. doi: 10.1002/da.22374. Epub 2015 May 22. PMID 26010478
  • Kroenke, K., Spitzer, R. L., & Williams, J. B. W. (1999). Patient Health Questionnaire-9 (PHQ-9). APA PsycTests, 10. https://doi.org/10.1037/t06165-000
  • Manea L, Gilbody S, McMillan D. A diagnostic meta-analysis of the Patient Health Questionnaire-9 (PHQ-9) algorithm scoring method as a screen for depression. Gen Hosp Psychiatry. 2015 Jan-Feb;37(1):67-75. doi: 10.1016/j.genhosppsych.2014.09.009. Epub 2014 Sep 23. PMID 25439733
  • Levis B, Benedetti A, Thombs BD; DEPRESsion Screening Data (DEPRESSD) Collaboration. Accuracy of Patient Health Questionnaire-9 (PHQ-9) for screening to detect major depression: individual participant data meta-analysis. BMJ. 2019 Apr 9;365:l1476. doi: 10.1136/bmj.l1476. PMID 30967483
  • Pliner P, Hobden K. Development of a scale to measure the trait of food neophobia in humans. Appetite. 1992 Oct;19(2):105-20. doi: 10.1016/0195-6663(92)90014-w. PMID 1489209
  • Rabadán, A., & Bernabéu, R. (2021). A systematic review of studies using the Food Neophobia Scale: Conclusions from thirty years of studies. Food Quality and Preference, 93, 104241. https://doi.org/10.1016/j.foodqual.2021.104241
  • Sorokowski, P., Sorokowska, A., Misiak, M., & Roberts, S. C. (2023). Developmental changes in food and non-food odor importance-Data from Scotland and Pakistan. Food Quality and Preference, 111, 104963.
  • Meyer, T. D., & Baur, M. (2009). Positive and negative affect in individuals at high and low risk for bipolar disorders. Journal of Individual Differences, 30(3), 169-175.

Identifiers

NCT: NCT07399626 · 1068/10.12.2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗