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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.

調査の概要

研究の種類

介入

入学 (推定)

16

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年~65年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:なし
  • 介入モデル:単一グループの割り当て
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
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.
時間枠: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.
時間枠: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.
時間枠: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.
時間枠: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.
時間枠: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.
時間枠: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.
時間枠: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.
時間枠: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.
時間枠: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.
時間枠: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.
時間枠: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.
時間枠:20 months

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

20 months

二次結果の測定

結果測定
メジャーの説明
時間枠
Resource outcomes:
時間枠:20 months

Time taken to recruit participants: Reported in days

20 months
Resource outcomes:
時間枠:20 months

Sample size calculation in number

20 months
Resource outcomes:
時間枠:20 months

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

20 months
Resource outcomes:
時間枠: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
時間枠:20 months

Participants experience of the intervention

20 months
Exploratory endpoints/outcomes
時間枠:20 months

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

20 months

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

  • 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

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2027年3月1日

一次修了 (推定)

2028年11月1日

研究の完了 (推定)

2028年11月1日

試験登録日

最初に提出

2026年10月16日

QC基準を満たした最初の提出物

2026年11月3日

最初の投稿 (実際)

2026年11月10日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月10日

QC基準を満たした最後の更新が送信されました

2026年11月3日

最終確認日

2026年11月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

Consent not given

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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