PSYCHOPATHY.COMP Program Among Male Prison Inmates With Psychopathy

NCT07481253 | Not Yet Recruiting

• 3 other identifiers: COMPETE2030-FEDER-00641100CEDI/FPCEUC: 105/R_5doi:10.54499/2023.18296.ICDT
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Antisocial Personality Disorder (ASPD)

Keywords

Antisocial behavior; Institutional behavior; Criminality; PSYCHOPATHY.COMP; Compassion Focused Therapy; Psychopathy

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  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

  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

  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)

Other Outcomes (4)

• Mediation Testing: participant-reported compassion-related variables

  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

• Mediation Testing: participant-reported compassion-related variables

  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

• Mediation Testing: participant-reported compassion-related variables

  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

Study Arms (2)

Treatment

EXPERIMENTAL

PSYCHOPATHY.COMP

Behavioral: PSYCHOPATHY.COMP

Control

ACTIVE COMPARATOR

Treatment as Usual (TAU)

Other: Treatment as Usual (TAU)

Interventions

PSYCHOPATHY.COMP BEHAVIORAL

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 known as: Treatment group

Treatment

Treatment as Usual (TAU) OTHER

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.

Also known as: Control group

Control

Eligibility Criteria

• Age: 19 Years - 30 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• suspected psychotic/autism spectrum disorders and/or cognitive impairments,
• female,
• sentence length inferior to 24 months since the start of the study.

Sponsors & Collaborators

• University of Coimbra: lead
• European Regional Development Fund: collaborator
• Portuguese National Funding Agency for Science, Research and Technology (FCT): collaborator

Study Sites (1)

Prisons of the Direção-Geral de Reinserção e Serviços Prisionais (DGRSP)

Lisbon, Portugal

Location

Related Publications (22)

• 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

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• Coelho, L., Paixão, R., & da Silva, J. T. (2010). O Levenson's Self Report Psychopathy Scale (LSRP). Psychologica, 53, 413-421

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• 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

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• 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

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• 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

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• Spielberger, C. D. (1988). Professional Manual for the State-Trait Anger Expression Inventory (STAXI). Odessa, FX: Psychological Assessment Resources

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• Hare, R. D. (2003). Manual for the revised psychopathy checklist (2nd ed.). Toronto, Canada: Multi-Health Systems

  BACKGROUND

• Paulhus, D. L., Neumann, C. S., & Hare, R. D. (2016). The SRP-4: Self-report psychopaty scale (4th ed.). Toronto, Canada: Multi-Health Systems

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  PMID: 22903867 BACKGROUND

• Pommier 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.

  PMID: 31516024 BACKGROUND

• Castilho 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.

  PMID: 25907562 BACKGROUND

• Silva, D. R., Campos, R., & Prazeres, N. (1999). O Inventário de Estado-Traço de Raiva (STAXI) e sua adaptação para a população portuguesa. Revista Portuguesa de Psicologia, 34, 55-81

  BACKGROUND

• Seara-Cardoso A, Queiros A, Fernandes E, Coutinho J, Neumann C. Psychometric Properties and Construct Validity of the Short Version of the Self-Report Psychopathy Scale in a Southern European Sample. J Pers Assess. 2020 Jul-Aug;102(4):457-468. doi: 10.1080/00223891.2019.1617297. Epub 2019 Jun 12.

  PMID: 31188025 BACKGROUND

• Knight, R. A., & Guay, J.-P. (2006). The Role of Psychopathy in Sexual Coercion against Women. In C. J. Patrick (Ed.), Handbook of psychopathy (pp. 512-532). The Guilford Press

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• Hare, R. D. (2020). The PCL-R assessment of psychopathy. In A. R. Felthous & H. Saß (Eds.), The Wiley International Handbook on Psychopathic Disorders and the Law (pp. 63-106). John Wiley & Sons. https://doi.org/10.1002/9781119159322.ch4

  BACKGROUND

• Brazao N, Rijo D, da Silva DR, do Ceu Salvador M, Pinto-Gouveia J. Personality Pathology Profiles as Moderators of the Growing Pro-Social Program: Outcomes on Cognitive, Emotion, and Behavior Regulation in Male Prison Inmates. J Pers Disord. 2021 Feb;35(1):84-113. doi: 10.1521/pedi_2019_33_424. Epub 2019 Apr 15.

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  PMID: 36608488 BACKGROUND

• Ribeiro da Silva D, Rijo D, Brazao N, Paulo M, Miguel R, Castilho P, Vagos P, Gilbert P, Salekin RT. The efficacy of the PSYCHOPATHY.COMP program in reducing psychopathic traits: A controlled trial with male detained youth. J Consult Clin Psychol. 2021 Jun;89(6):499-513. doi: 10.1037/ccp0000659.

  PMID: 34264698 BACKGROUND

MeSH Terms

Conditions

Antisocial Personality Disorder; Criminal Behavior

Interventions

Therapeutics; Control Groups

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: March 18, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Start date: March 2026 - no end date
• Access Criteria: IPD and supporting information will made open on the Open Science Framework (OSF)

Locations

PT (1)