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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.

研究概览

研究类型

介入性

注册 (估计的)

16

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 65年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的: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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
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.
大体时间: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.
大体时间: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.
大体时间: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.
大体时间: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.
大体时间: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.
大体时间: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.
大体时间: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.
大体时间: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.
大体时间: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.
大体时间: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.
大体时间: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.
大体时间:20 months

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

20 months

次要结果测量

结果测量
措施说明
大体时间
Resource outcomes:
大体时间:20 months

Time taken to recruit participants: Reported in days

20 months
Resource outcomes:
大体时间:20 months

Sample size calculation in number

20 months
Resource outcomes:
大体时间:20 months

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

20 months
Resource outcomes:
大体时间: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
大体时间:20 months

Participants experience of the intervention

20 months
Exploratory endpoints/outcomes
大体时间:20 months

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

20 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

  • 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

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2027年3月1日

初级完成 (估计的)

2028年11月1日

研究完成 (估计的)

2028年11月1日

研究注册日期

首次提交

2026年10月16日

首先提交符合 QC 标准的

2026年11月3日

首次发布 (实际的)

2026年11月10日

研究记录更新

最后更新发布 (实际的)

2026年11月10日

上次提交的符合 QC 标准的更新

2026年11月3日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

Consent not given

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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