PSYCHOPATHY.COMP Program Among Male Prison Inmates With Psychopathy

Condition(s) studied

Investigational drug(s) / intervention(s)

PSYCHOPATHY.COMP: Participants allocated to the treatment group will receive PSYCHOPATHY.COMP. PSYCHOPATHY.COMP is a manualized intervention of 20 weekly 60-min sessions (\~6 months) rooted in Compassion Focused Therapy (CFT). PSYCHOPATHY.COMP follows a progressive strategy of change in four modules: (1) The basics of our mind; (2) Our mind according to CFT; (3) Compassionate Mind Training; and (4) Recovery, relapse and prevention. As a common feature of all therapeutic sessions, therapists are focused on developing a secure therapeutic relationship. PSYCHOPATHY.COMP is delivered by psychologists skilled in CFT (including those from prisons). Psychologists will be trained (through an intensive, face-to-face 5-day training) and supervised (one session/month) by the research team during the delivery of the intervention. During PSYCHOPATHY.COMP, participants will not receive individual therapy (psychotherapy, psychological treatment) by an accredited psychologist or therapist.

Treatment as Usual (TAU): Participants in the control group will receive the routine support offered in the prison setting, tailored to individual case management and focused on behavioural management and adjustment.

Study summary

The goal of this clinical trial is to learn whether PSYCHOPATHY.COMP, an individual compassion-focused, therapy-based intervention of 20 weekly sessions, can reduce psychopathy in prison inmates. Psychopathy is linked with the most severe and persistent forms of antisocial behavior. This trial will also learn whether the program improves emotional and behavioral regulation.

The main questions are:

* Does PSYCHOPATHY.COMP reduce psychopathy?
* Does PSYCHOPATHY.COMP improve emotional and behavioral regulation? Researchers will compare PSYCHOPATHY.COMP with the usual individual case management support provided in prisons.

Portuguese-speaking adult male prison inmates will be invited to participate. Those who consent to participate will be screened for inclusion (T0). A total of 200 eligible participants will take part. All participants will be invited to complete a baseline assessment (T1, pre-treatment assessment), after which they will be randomly assigned to receive PSYCHOPATHY.COMP or the usual care provided in the prison for a period of around six months. All participants will be invited to complete a post-treatment assessment (T2) and a six-month follow-up assessment post-treatment. Assessments will collect data on sociodemographic characteristics and legal/criminal information, psychological outcomes (psychopathy, emotional regulation, and behavioral regulation), psychological mediators (mechanisms of change: compassion-related variables), and moderators (personality pathology), and data on social desirability.

This study aims to contribute to advancing scientific knowledge about whether and how to reduce psychopathy among prison inmates and have an impact on clinical practice and society by making available evidence-based interventions to this at-risk/high-risk population.

Eligibility

Primary outcome measure(s)

• Efficacy Testing: change from eligibility assessment in participant-reported psychopathy (primary outcome) to six-month follow-up — From eligibility to six months after the end of treatment. Measured at eligibility (T0), baseline assessment (T1, pre-treatment), within one month after the end of treatment (T2, post-treatment), and six months (T3, follow-up) after the end of treatment
  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 — From eligibility to six months after the end of treatment. Measured at eligibility (T0), baseline assessment (T1, pre-treatment), within one month after the end of treatment (T2, post-treatment), and six months (T3, follow-up) after the end of treatment
  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.

Trial sites (1)

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