NCT07846826

Brief 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 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
17mo left

Started Jan 2027

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 29, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2027

Expected
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

September 29, 2026

Status Verified

September 1, 2026

Enrollment Period

1.2 years

First QC Date

September 17, 2026

Last Update Submit

September 22, 2026

Conditions

Keywords

metacognitionMetacognitive Interpersonal Therapydomestic violence perpetratorssingle-case experimental designmultiple baselineforensic psychotherapyPortugal

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    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)

    Weekly from start of baseline (target of five weekly points) through Session 24 (approximately 7-8 months per participant)

  • Weekly psychological distress (CORE-10)

    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)

    Baseline (T0) and follow-up (T4, 8-10 weeks after Session 24)

  • Change in global psychological distress (CORE-OM)

    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)

    Baseline (T0), 16 weeks (T2), 24 weeks (T3, end of treatment) and 32-34 weeks (T4, follow-up) after treatment onset

  • +8 more secondary outcomes

Other Outcomes (9)

  • Working alliance (WAI-SR)

    Weeks 4, 8, 12, 16, 20 and 24 after treatment onset (Sessions 4, 8, 12, 16, 20 and 24)

  • Empathy (IRI)

    Baseline (T0), 8 weeks (T1), 16 weeks (T2), 24 weeks (T3, end of treatment) and 32-34 weeks (T4, follow-up) after treatment onset

  • Treatment fidelity index (TFI)

    Throughout treatment (24 weekly sessions, approximately 6 months)

  • +6 more other outcomes

Study Arms (1)

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).

Behavioral: Metacognitive Interpersonal Therapy for Male Domestic Offenders, Portuguese adaptation (MIT-MDO-PT)

Interventions

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%.

Also known as: MIT-MDO, Terapia Metacognitiva Interpessoal para Agressores de Violência Doméstica
MIT-MDO-PT

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsThe intervention (MIT-MDO) was developed for and adapted to male perpetrators of intimate partner violence; only men are eligible.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for the Rehabilitation of Domestic Violence Perpetrators (CRAVDA), Loures Municipality

Loures, Lisbon District, Portugal

Location

Related Publications (2)

  • 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

    BACKGROUND
  • 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.

    PMID: 41490723BACKGROUND

Related Links

MeSH Terms

Conditions

Personality Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Hugo C Vicente, MSc

    University of Beira Interior

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hugo C Vicente, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Single-group, open-label design. Outcome assessment at baseline (T0), end of treatment (T3, including the SCID-5-PD) and follow-up (T4) is performed by the same assessor, independent of the therapist and not involved in treatment delivery. The weekly monitoring series is self-completed by the participant on a secure platform before each session, without the therapist present. T1 and T2 assessments are unblinded. Treatment fidelity is rated by an independent rater blind to outcome data on 20% of sessions.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator, Doctoral Programme in Clinical and Health Psychology

Study Record Dates

First Submitted

September 17, 2026

First Posted

September 29, 2026

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

June 1, 2028

Last Updated

September 29, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
Data and code will become available within 12 months after study completion (anticipated by December 2028) and will remain available indefinitely on OSF.
Access Criteria
Open access to de-identified quantitative data and code via OSF. Any request for additional variables will be assessed by the Principal Investigator and the UBI Ethics Committee, in accordance with GDPR and Portuguese law; data-use agreements may be required.
More information

Locations