Antisocial Personality Disorder (ASPD)COMPATiNCT07481253
PSYCHOPATHY.COMP Program Among Male Prison Inmates With Psychopathy
A study testing PSYCHOPATHY.COMP and Treatment as Usual (TAU) in people with Antisocial Personality Disorder (ASPD), run by University of Coimbra at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 30 years, men only
- Conditions the study is for
- Antisocial Personality Disorder (ASPD)
- What is being tested?
- PSYCHOPATHY.COMP and Treatment as Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 sitePortugal
- Study dates
- 6 Apr 2026to 30 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 30 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- male prison inmates,
- Portuguese-speaking,
- aged between 19 and 30 years
- having at least one prior case in the juvenile justice system in which a judicial measure was applied,
- with high levels of psychopathic traits (measured with the SRP-SF and LSRPS self-reported questionnaires)
- with an Antisocial Personality Disorder (ASPD) diagnosis (measured with the SCID-II)
Who cannot join
- suspected psychotic/autism spectrum disorders and/or cognitive impairments,
- female,
- sentence length inferior to 24 months since the start of the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site, 1 recruiting
- Recruiting
Prisons of the Direção-Geral de Reinserção e Serviços Prisionais (DGRSP)
Lisbon
Ana Cristina Sabino Pestana Neves Subdirector of the DGRSP Organisational Unit, PhD, +351 218812200, ananeves@egasmoniz.edu.pt
About this study
Official title: COMPATi: A Randomized Controlled Trial on the Efficacy of the PSYCHOPATHY.COMP Program Among Male Prison Inmates With Psychopathy
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:
Read more
- 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.
Read the 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:
- 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:
- 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,
- Assess the mediating role of change in compassion-related variables on the efficacy of the PSYCHOPATHY.COMP,
- 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)
- Being tested
- PSYCHOPATHY.COMP, Treatment as Usual (TAU)
- Keywords
- Antisocial behavior, Institutional behavior, Criminality, PSYCHOPATHY.COMP, Compassion Focused Therapy, Psychopathy
- Medical subject headings
- Antisocial Personality Disorder, Criminal Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSYCHOPATHY.COMPBehavioural
Also called Treatment group
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.
Also called Control group
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 group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | PSYCHOPATHY.COMP Receives: Behavioral: PSYCHOPATHY.COMP |
| Control | Active comparator | Treatment as Usual (TAU) Receives: Other: Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
Secondary outcomes (3)
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.
Measured: From baseline to six months after the end of treatment. Measured at 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
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.
Measured: From baseline to six months after the end of treatment. Measured at 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
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).
Measured: From eligibility to six months after the end of treatment: from eligibility to baseline (T0-T1, pre-treatment), baseline to within one-month after treatment (T1-T2, during treatment), within one-month to six months after treatment (T2-T3, post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start6 Apr 2026
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Antisocial Personality Disorder (ASPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The allocation sequence will be generated by an external researcher using a 1:1 computer-generated blocked randomized allocation to the treatment (PSYCHOPATHY.COMP) or control (treatment as usual - TAU) groups. Allocation will be concealed using sequentially numbered opaque sealed envelopes. Study personnel who enroll and assign participants will have no access to the random allocation sequence. The randomization sequence will be stratified by prison with permuted random block sizes. The data analyst will be blinded to group allocation.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Coimbra
- Sponsor type
- University, hospital or other
- Collaborators
- European Regional Development Fund, Fundação para a Ciência e a Tecnologia
- Responsible party
- Principal investigator, Diana Ribeiro da Silva, University of Coimbra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07481253
- Sponsor's protocol ID
- COMPETE2030-FEDER-00641100
- Other IDs
- CEDI/FPCEUC: 105/R_5, doi:10.54499/2023.18296.ICDT
- Acronym
- COMPATi
- Status last verified
- Sep 2026
- First submitted
- 13 Mar 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol will be submitted for publication. Participant individual data will be de-identified but will not be shared due to confidentiality and privacy concerns related to the sensitive nature of the participant population. De-identified aggregate data may be available upon reasonable request, subject to ethical approval.
Publications
Ribeiro da Silva, D., de Carvalho, I. M., & Garofalo, C. (2024). Treatment of youth and adults with psychopathic traits detained in forensic settings: A systematic review. Aggression and Violent Behavior, 76, 101922. https://doi.org/10.1016/j.avb.2024.101922
Coelho, L., Paixão, R., & da Silva, J. T. (2010). O Levenson's Self Report Psychopathy Scale (LSRP). Psychologica, 53, 413-421
Goss, K., Gilbert, P., & Allan, S. (1994). An exploration of shame measures-I: The other as Shamer scale. Personality and Individual Differences, 17, 713-717. http://dx.doi.org/10.1016/0191-8869(94)90149-X
Matos, M., Pinto-Gouveia, J., Gilbert, P., Duarte, C., & Figueiredo, C. (2015). The Other As Shamer Scale-2: Development and validation of a short version of a measure of external shame. Personality and Individual Differences, 74, 6-11. https://doi.org/10.1016/j.paid.2014.09.037
Neff, K. D. (2003). Self-Compassion: An Alternative Conceptualization of a Healthy Attitude Toward Oneself. Self and Identity, 2, 85-101. https://doi.org/10.1080/15298860309032
Sousa, R., Castilho, P., Vieira, C., Vagos, P., & Rijo, D. (2017). Dimensionality and gender-based measurement invariance of the Compassion Scale in a community sample. Personality and Individual Differences, 117, 182-187. https://doi.org/10.1016/j.paid.2017.06.003
Sousa R, Paulo M, Brazao N, Castilho P, Rijo D. Measuring compassion toward others: Dimensionality of the compassion scale in community adolescents and in adolescents with behavioral disorders. Psychol Assess. 2022 Jul;34(7):631-642. doi: 10.1037/pas0001133. Epub 2022 Mar 31.
PubMed 35357875Spielberger, C. D. (1988). Professional Manual for the State-Trait Anger Expression Inventory (STAXI). Odessa, FX: Psychological Assessment Resources
Levenson MR, Kiehl KA, Fitzpatrick CM. Assessing psychopathic attributes in a noninstitutionalized population. J Pers Soc Psychol. 1995 Jan;68(1):151-8. doi: 10.1037//0022-3514.68.1.151.
PubMed 7861311Hare, R. D. (2003). Manual for the revised psychopathy checklist (2nd ed.). Toronto, Canada: Multi-Health Systems
Paulhus, D. L., Neumann, C. S., & Hare, R. D. (2016). The SRP-4: Self-report psychopaty scale (4th ed.). Toronto, Canada: Multi-Health Systems
First, M. B., Gibbon, M., Spitzer, R. L., Williams, J. B. W., & Benjamin, L. S. (1997). Structured Clinical Interview for DSM-IV Axis II Personality Disorders (SCID-II). Washington, DC: American Psychiatric Press.
Gilbert P, McEwan K, Matos M, Rivis A. Fears of compassion: development of three self-report measures. Psychol Psychother. 2011 Sep;84(3):239-55. doi: 10.1348/147608310X526511. Epub 2011 Apr 13.
PubMed 22903867Pommier E, Neff KD, Toth-Kiraly I. The Development and Validation of the Compassion Scale. Assessment. 2020 Jan;27(1):21-39. doi: 10.1177/1073191119874108. Epub 2019 Sep 13.
PubMed 31516024Castilho P, Pinto-Gouveia J, Duarte J. Evaluating the Multifactor Structure of the Long and Short Versions of the Self-Compassion Scale in a Clinical Sample. J Clin Psychol. 2015 Sep;71(9):856-70. doi: 10.1002/jclp.22187. Epub 2015 Apr 22.
PubMed 25907562
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPATi: A Randomized Controlled Trial on the Efficacy of the PSYCHOPATHY.COMP Program Among Male Prison Inmates With Psychopathy
- ClinicalTrials.gov ID
- NCT07481253
- Acronym / sponsor ID
- COMPATi / COMPETE2030-FEDER-00641100
- Conditions
- Antisocial Personality Disorder (ASPD)
- Keywords
- Antisocial behavior, Institutional behavior, Criminality, PSYCHOPATHY.COMP, Compassion Focused Therapy, Psychopathy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of CoimbraUniversity, hospital or other
- Collaborators
- European Regional Development Fund, Fundação para a Ciência e a Tecnologia
- Study start
- 6 Apr 2026 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 18 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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,
- Assess the mediating role of change in compassion-related variables on the efficacy of the PSYCHOPATHY.COMP,
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The allocation sequence will be generated by an external researcher using a 1:1 computer-generated blocked randomized allocation to the treatment (PSYCHOPATHY.COMP) or control (treatment as usual - TAU) groups. Allocation will be concealed using sequentially numbered opaque sealed envelopes. Study personnel who enroll and assign participants will have no access to the random allocation sequence. The randomization sequence will be stratified by prison with permuted random block sizes. The data analyst will be blinded to group allocation.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: PSYCHOPATHY.COMPPSYCHOPATHY.COMP |
| Control | Active comparator | Other: Treatment as Usual (TAU)Treatment as Usual (TAU) |
Who may qualify
- Ages
- 19 to 30 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- male prison inmates,
- Portuguese-speaking,
- aged between 19 and 30 years
- having at least one prior case in the juvenile justice system in which a judicial measure was applied,
- with high levels of psychopathic traits (measured with the SRP-SF and LSRPS self-reported questionnaires)
Key exclusion criteria (3 listed)
- suspected psychotic/autism spectrum disorders and/or cognitive impairments,
- female,
- sentence length inferior to 24 months since the start of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PSYCHOPATHY.COMPAlso: Treatment groupParticipants 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. | Behavioural | Treatment |
| Treatment as Usual (TAU)Also: Control groupParticipants 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. | Other | Control |
Primary outcome
Efficacy Testing: change from eligibility assessment in participant-reported psychopathy (primary outcome) to six-month follow-up
Time frame: 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
Time frame: 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.
3 secondary outcomes
Efficacy Testing: changes from baseline in participant-reported emotional regulation (secondary outcome) to six-month follow-up
Time frame: From baseline to six months after the end of treatment. Measured at 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
Efficacy Testing: changes from baseline in participant-reported emotional regulation (secondary outcome) to six-month follow-up
Time frame: From baseline to six months after the end of treatment. Measured at 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
Efficacy Testing: changes from eligibility in participant-reported behavioral regulation (secondary outcome) to six-month follow-up
Time frame: From eligibility to six months after the end of treatment: from eligibility to baseline (T0-T1, pre-treatment), baseline to within one-month after treatment (T1-T2, during treatment), within one-month to six months after treatment (T2-T3, post-treatment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- BackgroundRibeiro da Silva, D., de Carvalho, I. M., & Garofalo, C. (2024). Treatment of youth and adults with psychopathic traits detained in forensic settings: A systematic review. Aggression and Violent Behavior, 76, 101922. https://doi.org/10.1016/j.avb.2024.101922
- BackgroundCoelho, L., Paixão, R., & da Silva, J. T. (2010). O Levenson's Self Report Psychopathy Scale (LSRP). Psychologica, 53, 413-421
- BackgroundGoss, K., Gilbert, P., & Allan, S. (1994). An exploration of shame measures-I: The other as Shamer scale. Personality and Individual Differences, 17, 713-717. http://dx.doi.org/10.1016/0191-8869(94)90149-X
- BackgroundMatos, M., Pinto-Gouveia, J., Gilbert, P., Duarte, C., & Figueiredo, C. (2015). The Other As Shamer Scale-2: Development and validation of a short version of a measure of external shame. Personality and Individual Differences, 74, 6-11. https://doi.org/10.1016/j.paid.2014.09.037
- BackgroundNeff, K. D. (2003). Self-Compassion: An Alternative Conceptualization of a Healthy Attitude Toward Oneself. Self and Identity, 2, 85-101. https://doi.org/10.1080/15298860309032
- BackgroundSousa, R., Castilho, P., Vieira, C., Vagos, P., & Rijo, D. (2017). Dimensionality and gender-based measurement invariance of the Compassion Scale in a community sample. Personality and Individual Differences, 117, 182-187. https://doi.org/10.1016/j.paid.2017.06.003
- Background: PubMed 35357875Sousa R, Paulo M, Brazao N, Castilho P, Rijo D. Measuring compassion toward others: Dimensionality of the compassion scale in community adolescents and in adolescents with behavioral disorders. Psychol Assess. 2022 Jul;34(7):631-642. doi: 10.1037/pas0001133. Epub 2022 Mar 31.
- BackgroundSpielberger, C. D. (1988). Professional Manual for the State-Trait Anger Expression Inventory (STAXI). Odessa, FX: Psychological Assessment Resources
- Background: PubMed 7861311Levenson MR, Kiehl KA, Fitzpatrick CM. Assessing psychopathic attributes in a noninstitutionalized population. J Pers Soc Psychol. 1995 Jan;68(1):151-8. doi: 10.1037//0022-3514.68.1.151.
- BackgroundHare, R. D. (2003). Manual for the revised psychopathy checklist (2nd ed.). Toronto, Canada: Multi-Health Systems
- BackgroundPaulhus, D. L., Neumann, C. S., & Hare, R. D. (2016). The SRP-4: Self-report psychopaty scale (4th ed.). Toronto, Canada: Multi-Health Systems
- BackgroundFirst, M. B., Gibbon, M., Spitzer, R. L., Williams, J. B. W., & Benjamin, L. S. (1997). Structured Clinical Interview for DSM-IV Axis II Personality Disorders (SCID-II). Washington, DC: American Psychiatric Press.
- Individual participant dataSharing planned: Yes. The study protocol will be submitted for publication. Participant individual data will be de-identified but will not be shared due to confidentiality and privacy concerns related to the sensitive nature of the participant population. De-identified aggregate data may be available upon reasonable request, subject to ethical approval.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Prisons of the Direção-Geral de Reinserção e Serviços Prisionais (DGRSP)
Lisbon, Portugal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PSYCHOPATHY.COMP and Treatment as Usual (TAU) in people with Antisocial Personality Disorder (ASPD), run by University of Coimbra at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy Testing: change from eligibility assessment in participant-reported psychopathy (primary outcome) to six-month follow-up (time frame: 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07481253, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.