Intimate Partner ViolenceMIT-MDO-PTNCT07846826
Metacognitive Interpersonal Therapy for Male Intimate Partner Violence Perpetrators With Personality Disorders
A study testing Metacognitive Interpersonal Therapy for Male Domestic Offenders, Portuguese adaptation (MIT-MDO-PT) in people with Intimate Partner Violence and Personality Disorders, run by Hugo César Vicente at 1 site in Portugal.
Trial summary
This study evaluates the preliminary efficacy of MIT-MDO-PT, the European Portuguese cultural and linguistic adaptation of Metacognitive Interpersonal Therapy for Male Domestic Offenders (MIT-MDO), in adult men under judicial supervision for intimate partner violence (IPV) offences who meet criteria for a personality… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Intimate Partner Violence, Personality Disorders
- What is being tested?
- Metacognitive Interpersonal Therapy for Male Domestic Offenders, Portuguese adaptation (MIT-MDO-PT)
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 sitePortugal
- Study dates
- Jan 2027to Jun 2028
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male, aged 18 years or older
- Under judicial supervision (e.g., suspended sentence, provisional suspension of proceedings, or other court-ordered measure) for intimate partner violence offences, referred by the Directorate-General for Reintegration and Prison Services (DGRSP) or by the Hospital Beatriz Ângelo victim-support service
- Personality disorder confirmed by the SCID-5-PD (at least one diagnosis) AND elevation of at least one PID-5 domain (T-score >= 60, Portuguese norms)
- Current or recent intimate partner violence perpetration
- Voluntary informed consent, given independently of the judicial mandate
- Fluency in Portuguese
- Ability to commit to the 24-session weekly protocol
Who cannot join
- Psychopathy, operationalised as antisocial personality disorder confirmed by the SCID-5-PD together with a total score of 70 or above on the Self-Report Psychopathy Scale - Short Form (SRP-SF, European Portuguese version), administered at screening only to candidates meeting antisocial personality disorder criteria; clinical indicators from the screening interview and the referral file (generalised instrumental violence, absence of remorse and of affective bonding) are recorded as supporting information
- Active psychosis or severe cognitive impairment
- Imminent risk of harm to the victim requiring immediate protective intervention
- Substance dependence requiring concurrent intensive treatment
- Concurrent psychotherapy (ongoing pharmacotherapy is permitted)
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
Centre for the Rehabilitation of Domestic Violence Perpetrators (CRAVDA), Loures Municipality
Loures, Lisbon District
Hugo C Vicente, +351 913103116, hugo.cesar.vicente@ubi.pt
About this study
Official title: Preliminary Efficacy of the Portuguese Adaptation of Metacognitive Interpersonal Therapy for Male Domestic Offenders (MIT-MDO-PT) in Men Under Judicial Supervision for Intimate Partner Violence With Personality Disorders: A Preregistered Multiple-Baseline Single-Case Experimental Design With Partner-Reported External Validation
This study evaluates the preliminary efficacy of MIT-MDO-PT, the European Portuguese cultural and linguistic adaptation of Metacognitive Interpersonal Therapy for Male Domestic Offenders (MIT-MDO), in adult men under judicial supervision for intimate partner violence (IPV) offences who meet criteria for a personality disorder. MIT-MDO-PT is an individual psychotherapy of 24 weekly 50-minute sessions delivered over approximately six months in four phases (case formulation and metacognitive assessment; mentalization and affect regulation; memory rescripting and shame transformation; consolidation and relapse prevention). The study uses a preregistered nonconcurrent multiple-baseline single-case experimental design across participants (target N = 5-7; enrolment ceiling 7): each participant completes a baseline phase with weekly monitoring (target of five data points), and treatment onsets are fixed a priori and staggered by at least three weeks between participants to provide internal experimental control without randomization. Primary outcomes are self-reported IPV perpetration (Revised Conflict Tactics Scales, CTS2), metacognition (Metacognition Self-Assessment Scale, MSAS) and personality pathology (Personality Inventory for DSM-5, PID-5), assessed at baseline (T0), after sessions 8 (T1), 16 (T2) and 24 (T3) and at 8-10-week follow-up (T4), with weekly monitoring of IPV (CTS2 physical assault and psychological aggression subscales) and psychological distress (CORE-10) throughout baseline and treatment. Where available, partners are assessed independently by a hospital victim-support service at T0 and T3 (Danger Assessment-5, CTS2 partner version, Psychological Maltreatment of Women Inventory-Short Form). Outcome assessment at T0, T3 and T4 is performed by an assessor independent of the therapist. Objectively recorded violence-related incidents (police or judicial occurrences, breaches notified by the supervising services, hospital safety-protocol activations) are collected as a secondary outcome. Analyses are conducted per participant (reliable change index, percentage of non-overlapping data, non-overlap of all pairs, Tau-U, structured visual analysis), with study-level conclusions based on replication across participants. Treatment fidelity is monitored through structured session notes and blind rating of 20% of sessions. The study is preregistered on the Open Science Framework (osf.io/wqpnc; protocol update v3.1, September 2026) and has a favourable opinion from the Ethics Committee of the University of Beira Interior, subject to the formal authorizations of the referring institutions.
Read the detailed description
Background. Court-mandated psychoeducational programmes for intimate partner violence (IPV) perpetrators show small or null effects on recidivism and high attrition, particularly among men with personality pathology. Metacognitive Interpersonal Therapy (MIT) targets the metacognitive dysfunctions (monitoring, differentiation, integration, decentration, mastery) and maladaptive interpersonal schemas that underlie personality disorders. Its adaptation to male domestic offenders (MIT-MDO) has shown promising results in a proof-of-concept case series (Pasetto et al., 2026). The European Portuguese adaptation (MIT-MDO-PT) was developed following established cross-cultural adaptation standards and is preregistered separately (osf.io/r2x8g). The study protocol is registered on the Open Science Framework (osf.io/wqpnc; update v3.1, September 2026).
Design. Nonconcurrent multiple-baseline single-case experimental design across participants (single series; participants enter at different calendar times). Phase A (baseline): weekly monitoring with a target of five data points (minimum of three only when imminent risk requires earlier treatment; no data-dependent extension), using the brief monitoring set (CTS2 physical assault and psychological aggression subscales, 1-week recall, plus CORE-10). Phase B (intervention): 24 individual weekly sessions. Treatment onsets are fixed a priori, before baseline data are inspected, and staggered by at least three weeks between participants irrespective of referral pathway, so that the A-to-B change occurs at each participant's own onset rather than at a common calendar time, controlling for maturation, history and instrumentation drift. No randomization. Outcome assessment at T0, T3 (including the SCID-5-PD) and T4 is performed by the same assessor, independent of the therapist; the weekly series is self-completed on a secure platform before each session without the therapist present. Treatment fidelity is rated blindly on 20% of sessions by an independent rater (inter-rater ICC target >= .80 on 10% of rated sessions). Participants at imminent risk of harming the victim move directly to treatment, and the deviation is reported.
Assessment schedule. T0 (baseline): complete battery. T1 (after Session 8): CTS2, MSAS, CORE-OM, IRI. T2 (after Session 16): T1 set plus EDRE, IIP-32, TOSCA-3. T3 (after Session 24): complete battery and exit interview. T4 (8-10 weeks after Session 24): CTS2, MSAS, PID-5, IIP-32, CORE-OM, TOSCA-3, IRI. Weekly throughout Phases A and B: CTS2 physical assault and psychological aggression subscales and CORE-10 (act counts, 1-week recall). CTS2 at T1-T4 uses a "since the last assessment" recall period. Recorded violence-related incidents (new police or judicial occurrences, breaches of the judicial measure notified by DGRSP, activations of the hospital safety protocol) are logged per participant and phase as an objective secondary outcome; a serious adverse event is defined a priori and a study-level stopping rule applies. Screening for psychopathy: candidates meeting SCID-5-PD criteria for antisocial personality disorder complete the Self-Report Psychopathy Scale - Short Form (SRP-SF, Portuguese version); a total score of 70 or above is exclusionary. WAI-SR at Sessions 4, 8, 12, 16, 20 and 24.
Partner assessment. Administered exclusively by the victim-support team of Hospital Beatriz Angelo at T0 and T3, in fixed order: Danger Assessment-5 first (an elevated score immediately triggers the hospital safety protocol), then CTS2 partner version and PMWI-SF. Partner data are stored by the hospital separately from the research database; the research team receives de-identified data only. Two to five complete dyads are expected.
Analysis. No group-level inferential models. Per participant: reliable change index (Jacobson \& Truax) with |RCI| >= 1.96; percentage of non-overlapping data (PND >= 70%) and non-overlap of all pairs (NAP >= 0.66) on the weekly series, with Tau-U (uncorrected as the main index; trend-corrected as sensitivity analysis) and baseline-to-treatment rate difference; structured visual analysis following a named protocol (level, trend, variability, immediacy, overlap, consistency). Partner-exposure stratum (cohabiting, regular contact, no contact) is recorded and reported for the interpretation of the weekly IPV series. Participant-level decision: RCI criterion met plus at least one corroborating criterion. Study-level support when replicated in at least 3 of 5 participants (at least 4 if N = 6-7). Temporal precedence of metacognitive change over violence reduction examined by visual analysis (exploratory). Dyad-level concordance and change in number of personality disorder diagnoses are descriptive. Missing items below 20% within a scale are imputed by person mean; 20% or more, the score is not computed; no imputation of weekly series; last observation carried forward only as sensitivity analysis. Analysis code is written before data access.
Therapist and supervision. The intervention is delivered by the principal investigator (formal MIT training, Levels I-III) under weekly clinical supervision by the developer of MIT-MDO. Fidelity: structured session notes for all sessions; blind rating of 20% of sessions with the MIT-MDO-PT Session Fidelity Checklist; adherence threshold >= 80% for inclusion in primary efficacy analyses.
Start condition. Recruitment, data collection and intervention begin, for each referral pathway, only after the formal authorization of the corresponding referring institution (Hospital Beatriz Angelo; Directorate-General for Reintegration and Prison Services) has been presented to the Ethics Committee of the University of Beira Interior, closing the condition attached to its favourable opinion; the two pathways may open on different dates. Enrolment window: January to June 2027; ceiling of 7 participants including dropouts; replacement only before Session 12 and within the window; fewer than three completers triggers a feasibility report. Participants referred by the hospital are seen at the Centre for the Rehabilitation of Domestic Violence Perpetrators (CRAVDA) of Loures Municipality; the site for participants referred by the prison and reintegration services will be specified before that pathway opens.
Data sharing. De-identified participant-level data and analysis code will be deposited on the Open Science Framework at study end, subject to ethical and legal constraints; partner-reported data only in aggregate form.
- Conditions
- Intimate Partner Violence, Personality Disorders
- Being tested
- Metacognitive Interpersonal Therapy for Male Domestic Offenders, Portuguese adaptation (MIT-MDO-PT)
- Keywords
- metacognition, Metacognitive Interpersonal Therapy, domestic violence perpetrators, single-case experimental design, multiple baseline, forensic psychotherapy, Portugal
- Medical subject headings
- Personality Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metacognitive Interpersonal Therapy for Male Domestic Offenders, Portuguese adaptation (MIT-MDO-PT)Behavioural
Also called MIT-MDO, Terapia Metacognitiva Interpessoal para Agressores de Violência Doméstica
Manualised individual psychotherapy (24 weekly sessions, 50 minutes, approximately 6 months) adapted to European Portuguese from MIT-MDO. Phase I (Sessions 1-8): shared case formulation and metacognitive assessment; Phase II (Sessions 9-16): mentalization and affect regulation; Phase III (Sessions 17-21): memory rescripting and shame transformation; Phase IV (Sessions 22-24): consolidation and relapse prevention. Delivered by a psychologist trained in MIT (Levels I-III) under weekly clinical supervision by the model developer. Fidelity: structured session notes (100% of sessions) and blind rating of 20% of sessions with the MIT-MDO-PT Session Fidelity Checklist; adherence threshold >= 80%.
| Study group | Role | What they receive |
|---|---|---|
| MIT-MDO-PT | Experimental | Adult men under judicial supervision for intimate partner violence with a personality disorder receive 24 individual weekly 50-minute sessions of MIT-MDO-PT after a baseline phase with weekly monitoring (target of five weekly data points; minimum of three only under imminent risk). Treatment onsets are fixed a priori and staggered by at least three weeks between participants (nonconcurrent multiple-baseline design). Receives: Behavioral: Metacognitive Interpersonal Therapy for Male Domestic Offenders, Portuguese adaptation (MIT-MDO-PT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self-reported intimate partner violence perpetration (CTS2)
Revised Conflict Tactics Scales (CTS2), perpetration scales (physical assault, psychological aggression, sexual coercion, injury); European Portuguese version. Metric: reliable change index (RCI, Jacobson \& Truax) between T0 and T3; |RCI| >= 1.96 indicates reliable change; decrease = improvement.
Measured: Baseline (T0) and end of treatment (T3, after Session 24, approximately 6 months after treatment onset)
Change in metacognition (MSAS)
Metacognition Self-Assessment Scale (MSAS; Pedone et al., 2017; European Portuguese version: Faustino et al., 2021; 18 items; total score and four factor scores: self-reflexivity, critical distance, mastery, understanding other minds). Metric: RCI between T0 and T3 on the total score (|RCI| >= 1.96; increase = improvement). Factor scores reported descriptively.
Measured: Baseline (T0) and end of treatment (T3, after Session 24, approximately 6 months after treatment onset)
Change in personality pathology (PID-5)
Personality Inventory for DSM-5 (PID-5), adult form, five domain scores (T-scores, Portuguese norms). Metric: RCI between T0 and T3 per domain (|RCI| >= 1.96; decrease = improvement). Facets reported descriptively.
Measured: Baseline (T0) and end of treatment (T3, after Session 24, approximately 6 months after treatment onset)
Secondary outcomes (13)
Weekly intimate partner violence monitoring series (CTS2 subscales)
Sum of CTS2 physical assault and psychological aggression subscales (act counts, 1-week recall), self-completed by the participant on a secure platform before each session, collected weekly throughout baseline (Phase A) and treatment (Phase B). Metrics: percentage of non-overlapping data (PND >= 70%) and non-overlap of all pairs (NAP >= 0.66) between Phase A and Phase B, Tau-U (uncorrected as main index; trend-corrected as sensitivity analysis) with 95% CI, baseline-to-treatment rate difference, plus structured visual analysis following a named protocol (level, trend, variability, immediacy, overlap, consistency). Reported by partner-exposure stratum (cohabiting, regular contact, no contact).
Measured: Weekly from start of baseline (target of five weekly points) through Session 24 (approximately 7-8 months per participant)
Weekly psychological distress (CORE-10)
CORE-10 total score collected weekly throughout Phases A and B. Metrics: PND, NAP and structured visual analysis, Phase A versus Phase B.
Measured: Weekly from start of baseline (3-5 weeks) through Session 24 (approximately 7-8 months per participant)
Maintenance of gains at follow-up (CTS2, MSAS, PID-5)
RCI between T0 and T4 on the CTS2, MSAS total score and PID-5 domains; maintenance supported when |RCI| >= 1.96 with no reliable deterioration between T3 and T4.
Measured: Baseline (T0) and follow-up (T4, 8-10 weeks after Session 24)
Change in global psychological distress (CORE-OM)
Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM), total score, Portuguese version. Metric: RCI T0-T3 (|RCI| >= 1.96; decrease = improvement).
Measured: Baseline (T0), 8 weeks (T1), 16 weeks (T2), 24 weeks (T3, end of treatment) and 32-34 weeks (T4, follow-up) after treatment onset
Change in interpersonal problems (IIP-32)
Inventory of Interpersonal Problems - 32 items (IIP-32), total score. Metric: RCI T0-T3 (|RCI| >= 1.96; decrease = improvement).
Measured: Baseline (T0), 16 weeks (T2), 24 weeks (T3, end of treatment) and 32-34 weeks (T4, follow-up) after treatment onset
Change in emotion dysregulation (EDRE/DERS)
Difficulties in Emotion Regulation Scale, Portuguese version (EDRE), total score. Metric: RCI T0-T3 (|RCI| >= 1.96; decrease = improvement).
Measured: Baseline (T0), 16 weeks (T2) and 24 weeks (T3, end of treatment) after treatment onset
Change in impulsivity (SUPPS-P)
Short UPPS-P Impulsive Behavior Scale (SUPPS-P), total and facet scores, Portuguese version. Metric: RCI T0-T3 (|RCI| >= 1.96; decrease = improvement).
Measured: Baseline (T0) and 24 weeks after treatment onset (T3, end of treatment)
Change in alexithymia (TAS-20)
Toronto Alexithymia Scale - 20 items (TAS-20), total score, Portuguese version. Metric: RCI T0-T3 (|RCI| >= 1.96; decrease = improvement).
Measured: Baseline (T0) and 24 weeks after treatment onset (T3, end of treatment)
Change in shame- and guilt-proneness (TOSCA-3)
Test of Self-Conscious Affect (TOSCA-3), shame-proneness and guilt-proneness scales. Metric: RCI T0-T3 (|RCI| >= 1.96).
Measured: Baseline (T0), 16 weeks (T2), 24 weeks (T3, end of treatment) and 32-34 weeks (T4, follow-up) after treatment onset
Change in number of personality disorder diagnoses (SCID-5-PD)
Structured Clinical Interview for DSM-5 Personality Disorders (SCID-5-PD): number of personality disorder diagnoses met. Descriptive reporting only (no inferential threshold).
Measured: Baseline (T0) and 24 weeks after treatment onset (T3, end of treatment)
Partner-reported intimate partner violence (CTS2-P and PMWI-SF) - external validation
CTS2 partner version (CTS2-P) and Psychological Maltreatment of Women Inventory - Short Form (PMWI-SF), administered exclusively by hospital victim-support staff. Metric: per-informant change classification and dyad-level concordance category with perpetrator report (descriptive); ICC(2,1) exploratory only if at least 5 complete dyads.
Measured: Baseline (T0) and 24 weeks after treatment onset (T3, end of treatment)
Temporal precedence of metacognitive change over violence reduction (exploratory)
Per-participant visual analysis of the MSAS trajectory (T0-T2) and the weekly CTS2 monitoring series, classified as temporal precedence present, absent or indeterminate. No formal mediation model (N = 5-7).
Measured: Baseline (T0) through 24 weeks after treatment onset (T3, end of treatment)
Recorded violence-related incidents
Objectively recorded events, independent of self-report: new police or judicial occurrences for violence, breaches of the judicial measure notified by the Directorate-General for Reintegration and Prison Services, and activations of the hospital safety protocol. Counts per participant and per phase (baseline, treatment, follow-up), reported descriptively without a formal hypothesis. Any incident meeting the a priori definition of a serious adverse event is reported to the Ethics Committee and triggers the study-level stopping rule.
Measured: From consent through follow-up (T4, 8-10 weeks after Session 24; approximately 11 months per participant)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study startJan 2027 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intimate Partner ViolenceStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Nonconcurrent multiple-baseline single-case experimental design across participants. All participants receive the same intervention; each serves as his own control through a baseline phase (target of five weekly data points; minimum of three only when imminent risk requires earlier treatment) followed by treatment. Treatment onsets are fixed a priori, before baseline data are inspected, and staggered by at least three weeks between participants irrespective of referral pathway; participants may enter the study at different calendar times and be in different phases simultaneously. No comparison group and no randomization. Enrolment ceiling: 7 participants, including dropouts, enrolled between January and June 2027.
- Masking
- None (open label)
- Enrolment
- 7 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hugo César Vicente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hugo César Vicente, University of Beira Interior
- Investigators
- Hugo C Vicente, MSc, Principal investigator, University of Beira Interior
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07846826
- Sponsor's protocol ID
- MIT-MDO-PT-A2-2026
- Other IDs
- osf.io/wqpnc, CE-UBI-Pj-2026-044-ID-8651, osf.io/r2x8g
- Acronym
- MIT-MDO-PT
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant-level data (weekly repeated measures and pre/post questionnaire scores) and the analysis code will be deposited on the Open Science Framework (OSF) project page at study completion, subject to ethical and legal constraints (judicially supervised participants; approval by the UBI Ethics Committee). Partner-reported data will be shared only in aggregate or fully de-identified form to protect victim safety. Session recordings and clinical notes will not be shared.
Publications
Misso D, Schweitzer RD, Dimaggio G. Metacognition and mentalization in intimate partner violence perpetrators: Theoretical and clinical implications. J Psychother Integr. 2019;29(4):359-375. doi:10.1037/int0000111
Pasetto A, Misso D, Velotti P, Dimaggio G. Metacognitive interpersonal therapy for male domestic offenders (MIT-MDO) with personality disorders: A proof-of-concept case series. Psychol Psychother. 2026 Jun;99(2):463-483. doi: 10.1111/papt.70036. Epub 2026 Jan 5.
PubMed 41490723
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Efficacy of the Portuguese Adaptation of Metacognitive Interpersonal Therapy for Male Domestic Offenders (MIT-MDO-PT) in Men Under Judicial Supervision for Intimate Partner Violence With Personality Disorders: A Preregistered Multiple-Baseline Single-Case Experimental Design With Partner-Reported External Validation
- ClinicalTrials.gov ID
- NCT07846826
- Acronym / sponsor ID
- MIT-MDO-PT / MIT-MDO-PT-A2-2026
- Conditions
- Intimate Partner Violence, Personality Disorders
- Keywords
- metacognition, Metacognitive Interpersonal Therapy, domestic violence perpetrators, single-case experimental design, multiple baseline, forensic psychotherapy, Portugal
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 7 participants (estimated)
- Lead sponsor
- Hugo César VicenteUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 29 Sep 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.
This study evaluates the preliminary efficacy of MIT-MDO-PT, the European Portuguese cultural and linguistic adaptation of Metacognitive Interpersonal Therapy for Male Domestic Offenders (MIT-MDO), in adult men under judicial supervision for intimate partner violence (IPV) offences who meet criteria for a personality disorder. MIT-MDO-PT is an individual psychotherapy of 24 weekly 50-minute sessions delivered over approximately six months in four phases (case formulation and metacognitive assessment; mentalization and affect regulation; memory rescripting and shame transformation; consolidation and relapse prevention). The study uses a preregistered nonconcurrent multiple-baseline single-case experimental design across participants (target N = 5-7; enrolment ceiling 7): each participant completes a baseline phase with weekly monitoring (target of five data points), and treatment onsets are fixed a priori and staggered by at least three weeks between participants to provide internal experimental control without randomization. Primary outcomes are self-reported IPV perpetration (Revised Conflict Tactics Scales, CTS2), metacognition (Metacognition Self-Assessment Scale, MSAS) and personality pathology (Personality Inventory for DSM-5, PID-5), assessed at baseline (T0), after sessions 8 (T1), 16 (T2) and 24 (T3) and at 8-10-week follow-up (T4), with weekly monitoring of IPV (CTS2 physical assault and psychological aggression subscales) and psychological distress (CORE-10) throughout baseline and treatment. Where available, partners are assessed independently by a hospital victim-support service at T0 and T3 (Danger Assessment-5, CTS2 partner version, Psychological Maltreatment of Women Inventory-Short Form). Outcome assessment at T0, T3 and T4 is performed by an assessor independent of the therapist. Objectively recorded violence-related incidents (police or judicial occurrences, breaches notified by the supervising services, hospital safety-protocol activations) are collected as a secondary outcome. Analyses are conducted per participant (reliable change index, percentage of non-overlapping data, non-overlap of all pairs, Tau-U, structured visual analysis), with study-level conclusions based on replication across participants. Treatment fidelity is monitored through structured session notes and blind rating of 20% of sessions. The study is preregistered on the Open Science Framework (osf.io/wqpnc; protocol update v3.1, September 2026) and has a favourable opinion from the Ethics Committee of the University of Beira Interior, subject to the formal authorizations of the referring institutions.
Detailed description
Background. Court-mandated psychoeducational programmes for intimate partner violence (IPV) perpetrators show small or null effects on recidivism and high attrition, particularly among men with personality pathology. Metacognitive Interpersonal Therapy (MIT) targets the metacognitive dysfunctions (monitoring, differentiation, integration, decentration, mastery) and maladaptive interpersonal schemas that underlie personality disorders. Its adaptation to male domestic offenders (MIT-MDO) has shown promising results in a proof-of-concept case series (Pasetto et al., 2026). The European Portuguese adaptation (MIT-MDO-PT) was developed following established cross-cultural adaptation standards and is preregistered separately (osf.io/r2x8g). The study protocol is registered on the Open Science Framework (osf.io/wqpnc; update v3.1, September 2026).
Design. Nonconcurrent multiple-baseline single-case experimental design across participants (single series; participants enter at different calendar times). Phase A (baseline): weekly monitoring with a target of five data points (minimum of three only when imminent risk requires earlier treatment; no data-dependent extension), using the brief monitoring set (CTS2 physical assault and psychological aggression subscales, 1-week recall, plus CORE-10). Phase B (intervention): 24 individual weekly sessions. Treatment onsets are fixed a priori, before baseline data are inspected, and staggered by at least three weeks between participants irrespective of referral pathway, so that the A-to-B change occurs at each participant's own onset rather than at a common calendar time, controlling for maturation, history and instrumentation drift. No randomization. Outcome assessment at T0, T3 (including the SCID-5-PD) and T4 is performed by the same assessor, independent of the therapist; the weekly series is self-completed on a secure platform before each session without the therapist present. Treatment fidelity is rated blindly on 20% of sessions by an independent rater (inter-rater ICC target >= .80 on 10% of rated sessions). Participants at imminent risk of harming the victim move directly to treatment, and the deviation is reported.
Assessment schedule. T0 (baseline): complete battery. T1 (after Session 8): CTS2, MSAS, CORE-OM, IRI. T2 (after Session 16): T1 set plus EDRE, IIP-32, TOSCA-3. T3 (after Session 24): complete battery and exit interview. T4 (8-10 weeks after Session 24): CTS2, MSAS, PID-5, IIP-32, CORE-OM, TOSCA-3, IRI. Weekly throughout Phases A and B: CTS2 physical assault and psychological aggression subscales and CORE-10 (act counts, 1-week recall). CTS2 at T1-T4 uses a "since the last assessment" recall period. Recorded violence-related incidents (new police or judicial occurrences, breaches of the judicial measure notified by DGRSP, activations of the hospital safety protocol) are logged per participant and phase as an objective secondary outcome; a serious adverse event is defined a priori and a study-level stopping rule applies. Screening for psychopathy: candidates meeting SCID-5-PD criteria for antisocial personality disorder complete the Self-Report Psychopathy Scale - Short Form (SRP-SF, Portuguese version); a total score of 70 or above is exclusionary. WAI-SR at Sessions 4, 8, 12, 16, 20 and 24.
Partner assessment. Administered exclusively by the victim-support team of Hospital Beatriz Angelo at T0 and T3, in fixed order: Danger Assessment-5 first (an elevated score immediately triggers the hospital safety protocol), then CTS2 partner version and PMWI-SF. Partner data are stored by the hospital separately from the research database; the research team receives de-identified data only. Two to five complete dyads are expected.
Analysis. No group-level inferential models. Per participant: reliable change index (Jacobson \& Truax) with |RCI| >= 1.96; percentage of non-overlapping data (PND >= 70%) and non-overlap of all pairs (NAP >= 0.66) on the weekly series, with Tau-U (uncorrected as the main index; trend-corrected as sensitivity analysis) and baseline-to-treatment rate difference; structured visual analysis following a named protocol (level, trend, variability, immediacy, overlap, consistency). Partner-exposure stratum (cohabiting, regular contact, no contact) is recorded and reported for the interpretation of the weekly IPV series. Participant-level decision: RCI criterion met plus at least one corroborating criterion. Study-level support when replicated in at least 3 of 5 participants (at least 4 if N = 6-7). Temporal precedence of metacognitive change over violence reduction examined by visual analysis (exploratory). Dyad-level concordance and change in number of personality disorder diagnoses are descriptive. Missing items below 20% within a scale are imputed by person mean; 20% or more, the score is not computed; no imputation of weekly series; last observation carried forward only as sensitivity analysis. Analysis code is written before data access.
Therapist and supervision. The intervention is delivered by the principal investigator (formal MIT training, Levels I-III) under weekly clinical supervision by the developer of MIT-MDO. Fidelity: structured session notes for all sessions; blind rating of 20% of sessions with the MIT-MDO-PT Session Fidelity Checklist; adherence threshold >= 80% for inclusion in primary efficacy analyses.
Start condition. Recruitment, data collection and intervention begin, for each referral pathway, only after the formal authorization of the corresponding referring institution (Hospital Beatriz Angelo; Directorate-General for Reintegration and Prison Services) has been presented to the Ethics Committee of the University of Beira Interior, closing the condition attached to its favourable opinion; the two pathways may open on different dates. Enrolment window: January to June 2027; ceiling of 7 participants including dropouts; replacement only before Session 12 and within the window; fewer than three completers triggers a feasibility report. Participants referred by the hospital are seen at the Centre for the Rehabilitation of Domestic Violence Perpetrators (CRAVDA) of Loures Municipality; the site for participants referred by the prison and reintegration services will be specified before that pathway opens.
Data sharing. De-identified participant-level data and analysis code will be deposited on the Open Science Framework at study end, subject to ethical and legal constraints; partner-reported data only in aggregate form.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Nonconcurrent multiple-baseline single-case experimental design across participants. All participants receive the same intervention; each serves as his own control through a baseline phase (target of five weekly data points; minimum of three only when imminent risk requires earlier treatment) followed by treatment. Treatment onsets are fixed a priori, before baseline data are inspected, and staggered by at least three weeks between participants irrespective of referral pathway; participants may enter the study at different calendar times and be in different phases simultaneously. No comparison group and no randomization. Enrolment ceiling: 7 participants, including dropouts, enrolled between January and June 2027.
| Arm | Type | Receives |
|---|---|---|
| MIT-MDO-PT | Experimental | Behavioral: Metacognitive Interpersonal Therapy for Male Domestic Offenders, Portuguese adaptation (MIT-MDO-PT)Adult men under judicial supervision for intimate partner violence with a personality disorder receive 24 individual weekly 50-minute sessions of MIT-MDO-PT after a baseline phase with weekly monitoring (target of five weekly data points; minimum of three only under imminent risk). Treatment onsets are fixed a priori and staggered by at least three weeks between participants (nonconcurrent multiple-baseline design). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male, aged 18 years or older
- Under judicial supervision (e.g., suspended sentence, provisional suspension of proceedings, or other court-ordered measure) for intimate partner violence offences, referred by the Directorate-General for Reintegration and Prison Services (DGRSP) or by the Hospital Beatriz Ângelo victim-support service
- Personality disorder confirmed by the SCID-5-PD (at least one diagnosis) AND elevation of at least one PID-5 domain (T-score >= 60, Portuguese norms)
- Current or recent intimate partner violence perpetration
- Voluntary informed consent, given independently of the judicial mandate
Key exclusion criteria (5 listed)
- Psychopathy, operationalised as antisocial personality disorder confirmed by the SCID-5-PD together with a total score of 70 or above on the Self-Report Psychopathy Scale - Short Form (SRP-SF, European Portuguese version), administered at screening only to candidates meeting antisocial personality disorder criteria; clinical indicators from the screening interview and the referral file (generalised instrumental violence, absence of remorse and of affective bonding) are recorded as supporting information
- Active psychosis or severe cognitive impairment
- Imminent risk of harm to the victim requiring immediate protective intervention
- Substance dependence requiring concurrent intensive treatment
- Concurrent psychotherapy (ongoing pharmacotherapy is permitted)
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 |
|---|---|---|
| Metacognitive Interpersonal Therapy for Male Domestic Offenders, Portuguese adaptation (MIT-MDO-PT)Also: MIT-MDO, Terapia Metacognitiva Interpessoal para Agressores de Violência DomésticaManualised individual psychotherapy (24 weekly sessions, 50 minutes, approximately 6 months) adapted to European Portuguese from MIT-MDO. Phase I (Sessions 1-8): shared case formulation and metacognitive assessment; Phase II (Sessions 9-16): mentalization and affect regulation; Phase III (Sessions 17-21): memory rescripting and shame transformation; Phase IV (Sessions 22-24): consolidation and relapse prevention. Delivered by a psychologist trained in MIT (Levels I-III) under weekly clinical supervision by the model developer. Fidelity: structured session notes (100% of sessions) and blind rating of 20% of sessions with the MIT-MDO-PT Session Fidelity Checklist; adherence threshold >= 80%. | Behavioural | MIT-MDO-PT |
Primary outcome
Change in self-reported intimate partner violence perpetration (CTS2)
Time frame: Baseline (T0) and end of treatment (T3, after Session 24, approximately 6 months after treatment onset)
Revised Conflict Tactics Scales (CTS2), perpetration scales (physical assault, psychological aggression, sexual coercion, injury); European Portuguese version. Metric: reliable change index (RCI, Jacobson \& Truax) between T0 and T3; |RCI| >= 1.96 indicates reliable change; decrease = improvement.
Change in metacognition (MSAS)
Time frame: Baseline (T0) and end of treatment (T3, after Session 24, approximately 6 months after treatment onset)
Metacognition Self-Assessment Scale (MSAS; Pedone et al., 2017; European Portuguese version: Faustino et al., 2021; 18 items; total score and four factor scores: self-reflexivity, critical distance, mastery, understanding other minds). Metric: RCI between T0 and T3 on the total score (|RCI| >= 1.96; increase = improvement). Factor scores reported descriptively.
Change in personality pathology (PID-5)
Time frame: Baseline (T0) and end of treatment (T3, after Session 24, approximately 6 months after treatment onset)
Personality Inventory for DSM-5 (PID-5), adult form, five domain scores (T-scores, Portuguese norms). Metric: RCI between T0 and T3 per domain (|RCI| >= 1.96; decrease = improvement). Facets reported descriptively.
13 secondary outcomes
Weekly intimate partner violence monitoring series (CTS2 subscales)
Time frame: Weekly from start of baseline (target of five weekly points) through Session 24 (approximately 7-8 months per participant)
Weekly psychological distress (CORE-10)
Time frame: Weekly from start of baseline (3-5 weeks) through Session 24 (approximately 7-8 months per participant)
Maintenance of gains at follow-up (CTS2, MSAS, PID-5)
Time frame: Baseline (T0) and follow-up (T4, 8-10 weeks after Session 24)
Change in global psychological distress (CORE-OM)
Time frame: Baseline (T0), 8 weeks (T1), 16 weeks (T2), 24 weeks (T3, end of treatment) and 32-34 weeks (T4, follow-up) after treatment onset
Change in interpersonal problems (IIP-32)
Time frame: Baseline (T0), 16 weeks (T2), 24 weeks (T3, end of treatment) and 32-34 weeks (T4, follow-up) after treatment onset
Change in emotion dysregulation (EDRE/DERS)
Time frame: Baseline (T0), 16 weeks (T2) and 24 weeks (T3, end of treatment) after treatment onset
Change in impulsivity (SUPPS-P)
Time frame: Baseline (T0) and 24 weeks after treatment onset (T3, end of treatment)
Change in alexithymia (TAS-20)
Time frame: Baseline (T0) and 24 weeks after treatment onset (T3, end of treatment)
Change in shame- and guilt-proneness (TOSCA-3)
Time frame: Baseline (T0), 16 weeks (T2), 24 weeks (T3, end of treatment) and 32-34 weeks (T4, follow-up) after treatment onset
Change in number of personality disorder diagnoses (SCID-5-PD)
Time frame: Baseline (T0) and 24 weeks after treatment onset (T3, end of treatment)
Partner-reported intimate partner violence (CTS2-P and PMWI-SF) - external validation
Time frame: Baseline (T0) and 24 weeks after treatment onset (T3, end of treatment)
Temporal precedence of metacognitive change over violence reduction (exploratory)
Time frame: Baseline (T0) through 24 weeks after treatment onset (T3, end of treatment)
Recorded violence-related incidents
Time frame: From consent through follow-up (T4, 8-10 weeks after Session 24; approximately 11 months per participant)
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 29 Sep 2026.
- BackgroundMisso D, Schweitzer RD, Dimaggio G. Metacognition and mentalization in intimate partner violence perpetrators: Theoretical and clinical implications. J Psychother Integr. 2019;29(4):359-375. doi:10.1037/int0000111
- Background: PubMed 41490723Pasetto A, Misso D, Velotti P, Dimaggio G. Metacognitive interpersonal therapy for male domestic offenders (MIT-MDO) with personality disorders: A proof-of-concept case series. Psychol Psychother. 2026 Jun;99(2):463-483. doi: 10.1111/papt.70036. Epub 2026 Jan 5.
- Preregistered study protocol on the Open Science Framework, update v3.1 (September 2026) - MIT-MDO-PT single-case experimental studyLink provided by the sponsor.
- Cultural adaptation of Metacognitive Interpersonal Therapy for Portuguese perpetrators (MIT-MDO-PT) - OSF project pageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified participant-level data (weekly repeated measures and pre/post questionnaire scores) and the analysis code will be deposited on the Open Science Framework (OSF) project page at study completion, subject to ethical and legal constraints (judicially supervised participants; approval by the UBI Ethics Committee). Partner-reported data will be shared only in aggregate or fully de-identified form to protect victim safety. Session recordings and clinical notes will not be shared.
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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.
Hugo C Vicente, MSc principal investigator
University of Beira Interior
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metacognitive Interpersonal Therapy for Male Domestic Offenders, Portuguese adaptation (MIT-MDO-PT) in people with Intimate Partner Violence and Personality Disorders, run by Hugo César Vicente 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 7 inclusion and 5 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: opening soon, as of the sponsor's last update on 29 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?
Contact Hugo C Vicente, MSc (+351 913103116, hugo.cesar.vicente@ubi.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in self-reported intimate partner violence perpetration (CTS2) (time frame: Baseline (T0) and end of treatment (T3, after Session 24, approximately 6 months after treatment onset)). The study lists 3 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 NCT07846826, which also lists 2 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 29 Sep 2026.