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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-50
SponsorBabes-Bolyai University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

18-50 years of age

Not at high risk of suicide (current)

Not high SUDs / AUDs (current)

Native Romanian speaker

Disqualifiers

High risk of suicide (current)

High SUDs / AUDs (current)

Trial design

Design model

Sequential

Treatments tested in this trial

  • Hypomanic Personality Scale - 6

    Diagnostic test

    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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Community PilotingOther 1 intervention
Group B: Clinical / Risk GroupOther 1 intervention

Trial outcomes

Primary outcomes

1

Hypomanic Personality Scale - 6 (HPS-6)

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.

Time frame
Baseline and one month later for re-test measures (in order to account for test-retest reliability)
2

Mood Disorder Questionnaire (MDQ)

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).

Time frame
Baseline
3

Behavioral Inhibition System / Behavioral Activation System scales (BISBAS)

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).

Time frame
One month after Baseline
4

Positive and Negative Affect Schedule (PANAS)

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.

Time frame
One month after Baseline.

Secondary outcomes

1

Psychiatric Diagnostic Screening Questionnaire (PDSQ)

We used 12 of the 13 subscales of the Psychiatric Diagnostic Screening Questionnaire (PDSQ) to screen for additional psychiatric conditions. The depression subscale was excluded because depressive symptoms were assessed separately with the PHQ-9, and participants also underwent a formal clinical evaluation in which depression was examined in greater detail. The PDSQ is a self-administered screening instrument for common mental health disorders. The Romanian version includes 125 items, with higher scores indicating a greater risk for the respective disorder. Using these subscales, we assessed risk for PTSD, bulimia nervosa, obsessive-compulsive disorder, panic disorder, psychosis, agoraphobia, social phobia, alcohol use disorder, medication abuse, generalized anxiety disorder, and hypochondria (health anxiety).

Time frame
Baseline
2

Suicide Behavior Questionnaire-Revised (SBQ-R)

The SBQ-R is a brief, four-item measure that assesses multiple dimensions of suicidality and provides an overall suicide risk score. Scores of 7 or higher indicate elevated risk in non-clinical samples, whereas a cutoff of 8 or higher is used for clinical samples. Participants were not excluded based on suicide risk, as doing so could introduce bias into the research. Total scores range from 3 to 18.

Time frame
Baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.