PSYCHOPATHY.COMP Program Among Male Prison Inmates With Psychopathy

Efficacy Testing: change from eligibility assessment in participant-reported psychopathy (primary outcome) to six-month follow-up

Modified intention-to-treat (mITT, all participants randomized) and per protocol (PP, only participants who completed a sufficient dose) analyses of mean differences in participant-reported psychopathy between PSYCHOPATHY.COMP and TAU groups. Measured with the Self-Report Psychopathy Scale - Short-form (SRP-SF): a 29-item, shortened version of SRP-4 that assesses psychopathy according to the conceptualization of the Hare's Psychopathy Checklist - Revised. SRP-SF measures four facets of psychopathy: interpersonal (INT; 7 items), affective (AFF; 7 items), lifestyle (LIF; 7 items), and antisocial (ANT; 8 items). Items are rated on a five-point Likert-type scale, ranging from 1: "Strongly disagree" to 5: "Strongly agree". Total and subscale scores are computed by summing the corresponding individual item scores (after correcting for reversed items), with higher scores indicating higher levels of psychopathic traits.

Efficacy Testing: change from eligibility assessment in participant-reported psychopathy (primary outcome) to six-month follow-up

mITT and PP analyses of mean differences in participant-reported psychopathy between PSYCHOPATHY.COMP and TAU groups. Measured with the Levenson Self-Report Psychopathy Scale (LSRPS): a 26-item questionnaire assessing psychopathy in two domains: primary (selfish, callous, uncaring and manipulative; 16 items) and secondary (impulsivity and behavioural control; 10 items) psychopathy, which aligns with the conceptualization of the Hare's Psychopathy Checklist - Revised. Items are rated on a four-point Likert-type scale, ranging from 1: "Strongly disagree" to 4: "Strongly agree". Total and subscale scores are computed by summing the corresponding individual item scores (after correcting for reversed items), with higher scores indicating higher levels of psychopathy.

Efficacy Testing: changes from baseline in participant-reported emotional regulation (secondary outcome) to six-month follow-up

mITT and PP analyses of mean differences in emotional regulation between PSYCHOPATHY.COMP and TAU groups. Measured with State-Trait Anger Expression Inventory (STAXI): 44-item self-report questionnaire assessing anger-state (how one feels in the present moment; 10 items), anger-trait (how one generally feels, 10 items; with two factors: temperament and angry reaction, 4 items each), and anger-expression (how one generally reacts or behaves when feeling enraged or angry, 24 items; three factors: anger expression-in, anger expression-out and anger control, 8 items each). Items are rated on a four-point Likert-type scale from 1: "Not at all/almost never" to 4: "Very much so/almost always". Scale scores are computed by summing item scores, higher scores indicate higher levels of anger. Anger Expression scale is calculated as the sum of Anger Expression-In and Anger Expression-Out minus Anger Control, plus a constant.

Efficacy Testing: changes from baseline in participant-reported emotional regulation (secondary outcome) to six-month follow-up

mITT and PP analyses of mean differences in participant-reported emotional regulation between PSYCHOPATHY.COMP and TAU groups. Measured with the Other As Shamer Scale - 2 (OAS-2), a shorter form of the Other as Shamer scale (OAS). OAS-2 is an 8-item self-report questionnaire measuring external shame (i.e., subject's perception of being negatively judged by others). Items are rated on a five-point Likert-type scale, ranging from 0: "Never" to 4: "Almost always". The scale scores are computed by summing the corresponding individual item scores, with higher scores indicating higher levels of shame.

Efficacy Testing: changes from eligibility in participant-reported behavioral regulation (secondary outcome) to six-month follow-up

mITT and PP analyses of mean differences in participant-reported behavioral regulation between PSYCHOPATHY.COMP and TAU groups. Measured with an institutional behavioral grid (IBG) developed by the research team and previously used. IBG assessed the number/type of disciplinary infractions and the number of days of the punitive measures applied by the prison administration (collected from individual prison record files).

Mediation Testing: participant-reported compassion-related variables

mITT and PP analyses of mean differences in participant-reported emotional regulation between PSYCHOPATHY.COMP and TAU groups. Measured with the Self-Compassion Scale (SCS): a 26-item self-report questionnaire measuring six components (subscales) of self-compassion: self-kindness (5 items), self-judgment (5 items), common humanity (4 items), isolation (4 items), mindfulness (4 items), and overidentification (4 items). Items are rated on a five-point Likert-type scale, ranging from 1: "Almost never" to 5: "Almost always". Scores are computed by averaging item responses (after correcting for reversed items), with higher scores indicating higher levels of self-compassion.

Mediation Testing: participant-reported compassion-related variables

mITT and PP analyses of mean differences in participant-reported emotional regulation between PSYCHOPATHY.COMP and TAU groups. Measured with the Compassion Scale (CS): a 16-item self-report questionnaire measuring compassion towards others, composed of subscales representing kindness (4 items), common humanity (4 items), mindfulness (4 items), and indifference (4 items). Items are rated on a five-point Likert-type scale, ranging from 1: "Almost never" to 5: "Almost always". Scores are computed by averaging item responses (after correcting for reversed items), with higher scores indicating higher levels of compassion for others.

Mediation Testing: participant-reported compassion-related variables

mITT and PP analyses of mean differences in participant-reported emotional regulation between PSYCHOPATHY.COMP and TAU groups. Measured with the Fears of Compassion Scales (FCS): a 38-item self-report questionnaire that comprises three scales measuring: Fears of expressing compassion for others (10 items); Fears of receiving compassion from others (13 items), and Fears of compassion for self (15 items). Items are rated on a five-point Likert-type scale from 0 "Don't agree at all" to 4: "Completely agree". Scores are computed by averaging item responses, with higher scores indicating greater fears of compassion in the respective dimension.

Moderation Testing: participant-reported personality pathology pre-treatment

mITT and PP analyses of mean differences in personality pathology between PSYCHOPATHY.COMP and TAU groups. Measured with the Structured Clinical Interview for DSM-IV Axis II Personality Disorders (SCID-II): a semi-structured diagnostic interview assessing Axis II personality disorders from the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV), and the depressive and passive-aggressive personality disorders (included in DSM-IV's appendix). It can be used to diagnose personality disorders categorically (present/absent) and dimensionally (according to the number of criteria met for each diagnosis) and is considered the "gold standard" for Personality Disorders diagnosis. The SCID-II also provides a summary with a pathology profile of scores over the assessed Personality Disorders.