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Mentalization Orientated Psychoeducation Group for Adult ADHD (MOPAD) (MOPAD)

A Feasibility Study on Mentalization Orientated Psychoeducation Group for Adults With ADHD

Adults with Attention Deficit Hyperactivity Disorder (ADHD)-a neurodevelopmental condition affecting focus, impulse control, and activity levels-often face poor quality of life, emotion management difficulties, and interpersonal challenges. While medication helps core symptoms, it is not always tolerated or fully effective for emotional dysregulation. The National Institute for Health and Care Excellence (NICE) recommends psychological therapies as secondary options, but lacks sufficient evidence to endorse a specific intervention.

The MOPAD study tests whether an introductory Mentalization-Based Treatment (iMBT)-a psychological therapy helping people understand their own and others' mental states-can be delivered in a group format. MBT successfully improves mood and relationship issues in other conditions, offering potential non-drug benefits for adults with ADHD.

This non-randomised interventional feasibility study will recruit 16 adults with diagnosed ADHD. Participants will undertake a 12-week intervention of weekly 100-105 minute group iMBT sessions. Before and after the treatment, participants will complete standardized questionnaires assessing ADHD symptoms, quality of life, emotion regulation, impulsivity, and mentalizing capacity (e.g., ASRS v1.1, CAARS-2, AAQoL, DERS-18, UPPS, MENT-S, RFQ-8), alongside post-study qualitative interviews to share their experiences.

Eligible participants are adults with ADHD recruited from NHS clinical sites. Primary goals are evaluating recruitment (target: 11 participants), retention (target: 70%), safety, therapy fidelity, and patient acceptability. Secondary goals include evaluating clinician feedback and gathering resource data to calculate sample size requirements for a future full-scale trial.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

16

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 65 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • • A minimum age of 18 - 65 years at time of consent

    • Able to provide written consent with an Informed Consent Form signed by the participant
    • Have ADHD as principal diagnosis using following diagnostic instruments. DIVA or ACE under an NHS Neurodevelopmental Service completed within the last 24 months.
    • Proficient in spoken English.

Exclusion Criteria:

  • • Comorbidities of antisocial PD, autistic spectrum disorder, schizophrenia spectrum disorder, substance abuse disorder as principal or burdensome diagnosis, at the discretion of the PI.

    • On a titrating dose of ADHD or other Psychotropic medication.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Introductory Mentalization based group therapy

Adults with a Diagnosis of ADHD in last two years from a NHS Neurodevelopmental service.

A psychological therapy helping people understand their own and others' mental state. 12 weeks group intervention. Each session will last 100-105 minutes including 10-15 minutes break.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
This study will examine the feasibility of delivering 12 weekly sessions (90minutes/session plus 10/15 min break in between) of iMBT in a group format to adults with ADHD.
Lasso di tempo: 20 months

Recruitment rate :

The percentage of participants recruited in the study. It will be considered feasible if 11 out of 16 patients were recruited for the intervention.

20 months
This study will examine the feasibility of delivering 12 weekly sessions (90minutes/session plus 10/15 min break in between) of iMBT in a group format to adults with ADHD.
Lasso di tempo: 20 months

Attrition rate :

The percentage of participants retained in the study. It will be considered feasible if 70% were retained by the end of intervention.

20 months
The study also aims to compare pre and post iMBT group clinical outcome data.
Lasso di tempo: 20 months

ASRS V1.1 (Adult ADHD self-report scale) :

  • What it measures: Symptom frequency and presentation of adult ADHD over the prior 6 months, directly mapped to diagnostic criteria.
  • Score Range: Consists of 18 items split into Part A (6 core screening items) and Part B (12 tracking items). Items use a 5-point frequency scale (0 = Never to 4 = Very Often), yielding a total raw score range of 0 to 72.
  • Interpretation: Part A is the primary screening mechanism. If an individual marks 4 or more responses within the darkly shaded boxes in Part A, it indicates a high likelihood of ADHD and warrants a formal clinical evaluation. Part B tracks broader symptom severity across domains without a strict diagnostic cutoff.
20 months
The study also aims to compare pre and post iMBT group clinical outcome data.
Lasso di tempo: 20 months

CAARS-2 (Conners Adult ADHD Rating scale)

  • What it measures: Core ADHD symptoms and associated clinical impairments (such as emotional dysregulation and negative self-concept) in adults aged 18 and older.
  • Score Range: Raw scores from self and observer reports are converted into standardized T-scores, which typically range from below 30 to over 90. It also generates a dedicated ADHD Index probability score spanning 1% to 99%.
  • Interpretation: Standardized T-scores are normalized around a mean of 50. A T-score of 60-64 represents elevated symptoms, while a T-score of 65 or higher is considered clinically significant (highly elevated). For the ADHD Index, a probability score between 90% and 99% indicates a "Very High" likelihood that the profile matches individuals diagnosed with ADHD.
20 months
The study also aims to compare pre and post iMBT group clinical outcome data.
Lasso di tempo: 20 months

AAQoL (Adult ADHD Quality of life)

  • What it measures: The specific impact of ADHD on an individual's health-related quality of life over the past two weeks. It evaluates four distinct domains: Life Productivity, Psychological Health, Life Outlook, and Relationships.
  • Score Range: 29 items are originally rated on a 1-to-5 Likert scale, which are then reverse-scored and mathematically transformed onto a standardized scale of 0 to 100.
  • Interpretation: Higher scores indicate a better quality of life and fewer functional impairments. Scores are generally tiered into severity thresholds:
  • 76-100: Little to no quality-of-life impairment.
  • 51-75: Mild impairment.
  • 26-50: Moderate impairment.
  • 0-25: Severe functional impairment.
20 months
The study also aims to compare pre and post iMBT group clinical outcome data.
Lasso di tempo: 20 months

DERS-18 (Difficulties in Emotion regulation 18)

  • What it measures: Deficits in emotional regulation capacities across six dimensions: emotional non-acceptance, difficulty engaging in goal-directed behaviors, impulse control issues, lack of emotional awareness, limited access to regulation strategies, and lack of emotional clarity.
  • Score Range: 18 items scored on a 5-point Likert scale (1 = Almost Never to 5 = Almost Always). The total score ranges from 18 to 90.
  • Interpretation: Higher total and subscale scores indicate greater difficulties with emotion regulation (more severe dysregulation). It is highly useful in tracking treatment progress or evaluating clinical distress underlying internalizing psychopathology.
20 months
The study also aims to compare pre and post iMBT group clinical outcome data.
Lasso di tempo: 20 months

UPPS (Impulsive behaviour scale)

  • What it measures: Five distinct personality pathways that lead to impulsive action: Negative Urgency (acting rashly when distressed), Positive Urgency (acting rashly when overjoyed), Lack of Premeditation (failing to plan ahead), Lack of Perseverance (quitting difficult tasks), and Sensation Seeking.
  • Score Range: The full questionnaire consists of 59 statements rated from 1 (Agree Strongly) to 4 (Disagree Strongly). Items are averaged per dimension to yield an item mean scoring range from 1 to 4.
  • Interpretation: Higher item mean scores (closer to 4) represent higher levels of impulsivity along that specific dimension. Because the traits operate independently, an individual can score high on one trait (like Sensation Seeking) and low on another (like Negative Urgency)
20 months
The study also aims to compare pre and post iMBT group clinical outcome data.
Lasso di tempo: 20 months

MENT-S (The mentalization scale)

  • What it measures: The fundamental capacity to mentalize-meaning the reflective ability to perceive, interpret, and understand your own mental states as well as the mental states of others. It breaks down into Self-Related, Other-Related, and Motivation to Mentalize subscales.
  • Score Range: 28 items rated on a 5-point Likert scale (1 = Completely Untrue to 5 = Completely True). Total scores range from 28 to 140.
  • Interpretation: Higher total scores indicate a stronger global mentalization capacity and healthier, more adaptive reflective functioning. Lower scores indicate an impaired capacity to comprehend emotional or cognitive motivations behind human behavior.
20 months
The study also aims to compare pre and post iMBT group clinical outcome data.
Lasso di tempo: 20 months

RFQ-8 (Reflective function Questionnaire)

  • What it measures: Extreme variations in adult mentalizing capabilities, explicitly flagging hypomentalizing (an inability to consider mental states) or hypermentalizing (developing overly complex, inaccurate assumptions about the mind).
  • Score Range: 8 items rated on a 1-to-7 scale. Using the primary scoring algorithm, items are recoded to center around an optimal middle ground, yielding subscale score ranges (Certainty vs. Uncertainty) from 0 to 3.
  • Interpretation:
  • Uncertainty Subscale (RFQ_U): High scores indicate hypomentalizing, pointing to a concrete lack of knowledge about mental states.
  • Certainty Subscale (RFQ_C): Moderate scores indicate healthy, realistic certainty about the mind. Conversely, extreme high scores on this subscale reflect hypermentalizing (assuming absolute, ungrounded insight into what others are thinking)
20 months
The study also aims to compare pre and post iMBT group clinical outcome data.
Lasso di tempo: 20 months

Adverse events (AE) or serious AE during the trial. This will counted in numbers identified through a clear process outlined in protocol.

20 months
The study also aims to compare pre and post iMBT group clinical outcome data.
Lasso di tempo: 20 months

Fidelity of delivery : Adherence will be measured through supervision of the sessions and report from supervisors.

20 months
The study also aims to compare pre and post iMBT group clinical outcome data.
Lasso di tempo: 20 months

Acceptability of the intervention to participants: through interview of the participants. Will be reported as themes and quotes from participants.

20 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Resource outcomes:
Lasso di tempo: 20 months

Time taken to recruit participants: Reported in days

20 months
Resource outcomes:
Lasso di tempo: 20 months

Sample size calculation in number

20 months
Resource outcomes:
Lasso di tempo: 20 months

Data collection success (percentage of participants completed the outcome measures)

20 months
Resource outcomes:
Lasso di tempo: 20 months

Initial assessment of the financial resources required to scale the study: reported in number of professionals involved and how much on average they had to offer in hours/week from the onset of recruitment to completion of the trial.

20 months
Exploratory endpoints/outcomes
Lasso di tempo: 20 months

Participants experience of the intervention

20 months
Exploratory endpoints/outcomes
Lasso di tempo: 20 months

Facilitators' and Co-facilitators' experience of the intervention.

20 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

  • American Psychiatric Association. (2013). Diagnostic and statistical manual of mental disorders (5th ed.). American Psychiatric Publishing. Badoud, D., Rüfenacht, E., Debbané, M., & Perroud, N. (2018). Mentalization-based treatment for adults with attention-deficit/hyperactivity disorder: a pilot study. Research in Psychotherapy: Psychopathology, Process and Outcome, 21(1). Barkley, R. A. (2015). Attention-deficit hyperactivity disorder: A handbook for diagnosis and treatment (4th ed.). Guilford Publications. Bateman, A., & Fonagy, P. (2010). Randomized Controlled Trial of Outpatient Mentalization-Based Treatment Versus Structured Clinical Management for Borderline Personality Disorder. Focus, 8(1), 55-65. Bateman, A., Fonagy, P., Campbell, C., Luyten, P., & Debbané, M. (Eds.). (2023). Cambridge Guide to Mentalization-Based Treatment (MBT). Cambridge University Press. Bora, E., & Pantelis, C. (2016). Meta-analysis of social cognition in attention-deficit/hyperactivity disorder (ADHD): Expectation of deficits relative to controls and comparison with autism spectrum disorder. Psychological Medicine, 46(4), 681-704. Brown, N. M., Flood, T. J., Sarocco, P., Atkins, M. S., & Khachatryan, M. (2017). Social Determinants of Health and ADHD Symptoms in Preschool-Age Children. Journal of Attention Disorders, 26(3), 447-455. Cortese, S., Cinzia, D. G., Chamberlain, S., Philipsen, A., Young, S., Bilbow, A., & Cipriani, A. (2022). Pharmacological and non-pharmacological interventions for adults with ADHD: Protocol for a systematic review and network meta-analysis. BMJ Open, 12(3). https://doi.org/10.1136/bmjopen-2021-058102 Faraone, S. V., Asherson, P., Banaschewski, T., Biederman, J., Buitelaar, J. K., Ramos-Quiroga, J. A., ... & Franke, B. (2015). Attention-deficit/hyperactivity disorder. Nature Reviews Disease Primers, 1(1), 1-23. Fayyad, J., De Graaf, R., Kessler, R., Alonso, J., Angermeyer, M., Demyttenaere, K., ... & Jin, R. (2007). Cross-national prevalence and

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 marzo 2027

Completamento primario (Stimato)

1 novembre 2028

Completamento dello studio (Stimato)

1 novembre 2028

Date di iscrizione allo studio

Primo inviato

16 ottobre 2026

Primo inviato che soddisfa i criteri di controllo qualità

3 novembre 2026

Primo Inserito (Effettivo)

10 novembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 novembre 2026

Ultimo verificato

1 novembre 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • SABPNHS

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Consent not given

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .