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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.

Studieöversikt

Studietyp

Interventionell

Inskrivning (Beräknad)

16

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 65 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 20 months

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

20 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Resource outcomes:
Tidsram: 20 months

Time taken to recruit participants: Reported in days

20 months
Resource outcomes:
Tidsram: 20 months

Sample size calculation in number

20 months
Resource outcomes:
Tidsram: 20 months

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

20 months
Resource outcomes:
Tidsram: 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
Tidsram: 20 months

Participants experience of the intervention

20 months
Exploratory endpoints/outcomes
Tidsram: 20 months

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

20 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

  • 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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 mars 2027

Primärt slutförande (Beräknad)

1 november 2028

Avslutad studie (Beräknad)

1 november 2028

Studieregistreringsdatum

Först inskickad

16 oktober 2026

Först inskickad som uppfyllde QC-kriterierna

3 november 2026

Första postat (Faktisk)

10 november 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

10 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

3 november 2026

Senast verifierad

1 november 2026

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

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NEJ

IPD-planbeskrivning

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Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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