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临床试验/NCT07399626
NCT07399626招募中1 期

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

Babes-Bolyai University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年9月22日最近更新:
干预措施

试验速览

阶段
1 期
状态
招募中
发起方
入组人数
50
试验地点
1
主要终点
Hypomanic Personality Scale - 6 (HPS-6)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Sequential
主要目的
Screening
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

Clinical Psychologists conducting the clinical interviews are blinded to participant's diagnosis (from intake form), as well as study scales and scope of the study.

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

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

研究组 & 干预措施

Community Piloting

Other

Meant for piloting scale, EFA

干预措施: Hypomanic Personality Scale - 6 (Diagnostic Test)

Clinical / Risk Group

Other

Formally clinically evaluated sample, used for CFA

干预措施: Hypomanic Personality Scale - 6 (Diagnostic Test)

结局指标

主要结局

Hypomanic Personality Scale - 6 (HPS-6)

时间窗: Baseline and one month later for re-test measures (in order to account for test-retest reliability)

The main instrument of the study, the HPS-6 is used to assess bipolar spectrum disorder risk due to and individual's phenotype. The scale contains 6 items and has a binary rating scale ("TRUE" / "FALSE"). The original authors used a cut-off of 3 or higher to represent possible risk for the disorder. Minimum score possible is 0, while the highest is 6.

Mood Disorder Questionnaire (MDQ)

时间窗: Baseline

In order to check for convergent validity, the Mood Disorder Questionnaire was administered as well. The instrument screens for a history of manic or hypomanic symptoms. It contains 13 yes or no items created based on the DSM-IV, followed by a 4-point Likert question on the level of impairment; "no problem" to "serious problem" and a 15th item asking is symptoms happened simultaneously. Studies recommend a cut-off of \>5 for high risk bipolar populations. The original cut-off of the scale is \>7, but it has been criticized for high specificity. The total score is 13 (MIN: 0, MAX: 13).

Behavioral Inhibition System / Behavioral Activation System scales (BISBAS)

时间窗: One month after Baseline

The BIS / BAS scales assess two motivational systems, the Behavioral Inhibition System and the Behavioral Activation System. The scale contains 20 items in total. The BAS system, or the approach tendency, is hypothesized to facilitate goal-motivated behavior when presented with incentives, generating an increase in behaviors oriented towards goals, while the BIS motivational system activates inhibition tendencies. Higher scores indicate sensitivity to threats, non-reward (BIS) or the sensitivity towards reward and goal striving (BAS). Total possible score for the BIS subscale is 28 (MIN: 7, MAX: 28), while for the BAS subscale the total possible is 91 (MIN: 13, MAX: 91).

Positive and Negative Affect Schedule (PANAS)

时间窗: One month after Baseline.

The Positive and Negative Affect Schedule is a 20-item self-report measure assessing positive and negative affect. Participants rate each item on a 5-point Likert scale ranging from 1 ("very slightly or not at all") to 5 ("extremely"). Each subscale has a possible score range of 10 to 50. Higher PA scores reflect greater energy and concentration, whereas higher NA scores indicate greater levels of distress.

Negative Urgency, Premeditation, Perseverance, Sensations Seeking, and Positive Urgency - Impulsive Behavior Scale (UPPS-P)

时间窗: One month after Baseline

The UPPS-P Impulsive Behavior Scale assesses positive and negative emotional urgency along with multiple dimensions of impulsivity. The full instrument includes 59 items across five subscales: Negative Urgency, Positive Urgency, (Lack of) Premeditation, (Lack of) Perseverance, and Sensation Seeking. A scoping review has shown that individuals with bipolar disorder exhibit elevated impulsivity during both positive and negative emotional states, with particularly large effect sizes observed for positive urgency. Because the HPS-6 focuses on positively valenced experiences, only the Positive Urgency subscale was administered in this study. Scores on this subscale range from 14 to 56, with higher average scores indicating greater impulsive tendencies.

Affective Lability Scale - Short Form (ALS-18)

时间窗: One month after Baseline

The ALS-18 is an 18-item measure designed to assess shifts between neutral states and intense affect, emphasizing emotional variability rather than current symptom severity. It comprises three main subscales: Anxiety/Depression Shift (5 items), Depression/Elation Shift (8 items), and Anger (5 items). Items are rated on a 4-point Likert scale ranging from 0 ("very uncharacteristic of me") to 3 ("very characteristic of me"). The total raw score ranges from 0 to 54, with higher scores indicating greater affective lability, reflected in more frequent and intense mood shifts.

Positive Overgeneralization (POG)

时间窗: One month after Baseline.

The Positive Overgeneralization Scale (POG) measures the "tendency to generalize good experiences in one domain to broader aspects of life". it contains 3 subscales (lateral generalization, upward generalization and social generalization), comprising altogether 16 items. Lower scores represent a higher predisposition towards that type of positive overgeneralization (Subscale 1 - Lateral generalization: MAX - 30, MIN: 6 , Subscale 2 - Upward generalization: MAX - 25, MIN - 5, Subscale 3 - Social generalization: MAX - 25, MIN - 5).

Altman Self-Rating Mania Scale (ASRM)

时间窗: Baseline

The instrument evaluates manic symptom presence and their severity using 5 items, rated on a 4-point Likert scale. Total scores span from 0 to 20, and scores of 6 or above suggest a possible presence of hypomanic or manic symptoms.

Food Neophobia Scale (FNS)

时间窗: Baseline

The scale measures one's reluctance to try new or unfamiliar foods. The FNS consists of 10 items rated on a 7-point Likert scale. It has been widely used internationally across diverse fields. Five items assess neophobic behavior, defined as fear of new or unfamiliar experiences, while the remaining five assess neophilic behavior, reflecting interest in and enthusiasm for novelty. Higher FNS scores indicate greater levels of neophobia (MIN: 10, MAX: 70).

Patient Health Questionnaire-9 (PHQ-9)

时间窗: Baseline

The Patient Health Questionnaire-9 is a diagnostic tool for depression based on DSM-IV criteria. It includes nine items rated on a 4-point Likert scale ranging from 0 ("Not at all") to 3 ("Nearly every day"). Using the algorithm method, a diagnosis is indicated when five or more symptoms have been present for more than half of the days over the past two weeks. Total scores range from 0 to 21. Alternatively, the summed-item approach involves adding the item scores, with a commonly used cutoff of 10 points to indicate major depressive disorder.

Importance of Olfaction (IOS)

时间窗: Baseline

The Importance of Olfaction scale assesses core olfactory functions. It consists of 18 items rated on a 5-point Likert scale ranging from 1 ("strongly disagree") to 5 ("strongly agree"). The scale was designed for use across different cultures and age groups. It includes five subscales reflecting various domains of the importance of smell (e.g., mating and bonding). Total scores range from 18 to 90, with higher scores indicating a greater personal importance attributed to the sense of smell.

次要结局

  • Psychiatric Diagnostic Screening Questionnaire (PDSQ)(Baseline)
  • Suicide Behavior Questionnaire-Revised (SBQ-R)(Baseline)

研究者

发起方
Babes-Bolyai University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Renata Gheorghiu

Principal Investigator

Babes-Bolyai University

研究点 (1)

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