NCT07481253

PSYCHOPATHY.COMP Program Among Male Prison Inmates With Psychopathy

COMPATi: A Randomized Controlled Trial on the Efficacy of the PSYCHOPATHY.COMP Program Among Male Prison Inmates With Psychopathy

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: University of Coimbra · Academic / Other
• Sex: Male
• Age: 19 Years – 30 Years
• Healthy volunteers: Not accepted

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.

Detailed description

There has long been interest in the study of psychopathy, defined as a set of interpersonal (e.g., grandiosity, manipulation), affective (e.g., callousness, unemotionality), deviant lifestyle (e.g., impulsivity, irresponsibility), and antisocial traits (e.g., criminal versatility). Psychopathy is usually associated with the most severe and persistent forms of antisocial behavior, being a strong predictor of violent behavior and overall criminal recidivism. Given that inmates with psychopathy represent 15-40% of the in-prison population (depending on the risk level of the sample and type of crime), delivering evidence-based interventions specifically tailored to their needs, mitigating the clinical and societal costs of psychopathy and antisocial behavior, is of utmost relevance. To our knowledge, the PSYCHOPATHY.COMP is the first program specifically designed to reduce psychopathy and antisocial behavior through the promotion of a compassionate motivation. PSYCHOPATHY.COMP consists of a structured, individual, 20-session therapy-based intervention based on Compassion Focused Therapy (CFT). Results from a (nonrandomized) controlled clinical trial showed that the PSYCHOPATHY.COMP is an effective treatment for reducing psychopathic traits and disruptive behavior in detained youth, as well as for promoting compassionate motivation and emotion regulation (medium/large effect sizes), with compassionate motivation having a significant mediating effect on the changeability of psychopathic traits. Results showed treatment effects were sustained for up to six months after the intervention. Despite these findings, it is unknown whether prison inmates with psychopathy can benefit from this program, as they are considered more resistant to treatment than their youth counterparts. This project aims to test the efficacy of the PSYCHOPATHY.COMP in reducing psychopathic traits, as well as in promoting emotion and behavior regulation among male adults (19-30 years; developmentally closer age range of detained youth) prison inmates through the promotion of a compassionate motivation. COMPATi aims to test the efficacy of the PSYCHOPATHY.COMP among adult male prison inmates with antisocial personality disorder (ASPD) and high levels of psychopathic traits. Specifically, it aims to: PRIMARY GOALS: 1. Test the efficacy of the PSYCHOPATHY.COMP in reducing psychopathic traits (primary outcome) when compared with Treatment as Usual (TAU) within one month after the treatment completion, and assess the stability of change up to six months after treatment, SECONDARY GOALS: 2. Test the efficacy of the PSYCHOPATHY.COMP in promoting emotion and behavior regulation (secondary outcomes) when compared with TAU within one month after the treatment completion, and assess the stability of change up to six months after treatment, 3. Assess the mediating role of change in compassion-related variables on the efficacy of the PSYCHOPATHY.COMP, 4. Assess the moderating effect of personality pathology on the efficacy of the PSYCHOPATHY.COMP. This is a pre-registered, multi-center, two-arm, parallel, blinded (by data analysts), randomized controlled trial (RCT) with 1:1 computer-generated, blocked randomized allocation to treatment (allocated to receive PSYCHOPATHY.COMP) or control (allocated to receive the treatment as usual - TAU) groups. A total of 200 Portuguese-speaking adult male prison inmates are estimated to be recruited from 10 randomly selected high-security male prisons in Portugal, for a total of 19 prisons. Male prison inmates are consecutively screened for inclusion (T0). Those who consent to participate and meet the inclusion criteria are invited to complete the baseline T1 assessment. After the T1 assessment, participants are randomly allocated to the treatment or control groups. PSYCHOPATHY.COMP is delivered by psychologists (including those from prisons) for about 6 months. Treatment integrity will be ensured by following established recommendations: psychologists will be trained (through an intensive, face-to-face 5-day training) and supervised (one session per month) during the delivery of the intervention (training/supervision is carried out by the research team members); therapists and participants will rate every session on their subjective perception regarding the usefulness of the session and the therapeutic relationship (therapist will also rate every session on their subjective perception regarding how they follow the manualized protocol of the session and their overall rating of the sessions); as sessions cannot be audio- or video-recorded for ethical reasons, CFT experts from the research team will observe and rate 20% of the sessions using a measure of treatment integrity for the CFT approach. All participants are then invited to complete an assessment within one month after treatment (T2) and a follow-up assessment at 6 months post-treatment (T3). Assessments will collect sociodemographic and legal/criminal data (at T1), data on psychological mediators (compassion-related variables; at T1-T3), and outcomes. In this latter, psychopathy (primary outcome) will be assessed at T0-T3, emotional regulation (secondary outcome) at T1-T3, and behavioral regulation (secondary outcome) will be observed over time, covering the period from T0 to T3. Social desirability will also be controlled for and assessed at T1-T3. The evaluation of personality pathology (psychological moderator) will be conducted at eligibility (T0, for ASPD) and at baseline (T1, for other personality disorders) using a structured clinical interview. All assessments rely on self-report and observable data (collected from prison record files) and are conducted by the research team. A priori power analyses estimate that a minimum of 171 participants is necessary to detect medium effects (significance level of .05, power of .90). Accounting for participation and attrition rates, a minimum of 200 individuals need to be recruited. Results aim to provide foundational knowledge of PSYCHOPATHY.COMP's efficacy among prison inmates. Results will inform the potential benefits and implementation of PSYCHOPATHY.COMP in prison settings in Portugal and its potential translation to other countries, helping to answer the clinical and societal need to make available evidence-based interventions to this at-risk/high-risk population.

Conditions

• Antisocial Personality Disorder (ASPD)

Interventions

Type	Name	Description
BEHAVIORAL	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.
OTHER	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.

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-11-30
• Completion: 2027-11-30
• First posted: 2026-03-18
• Last updated: 2026-03-24

Locations

1 site across 1 country: Portugal