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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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

16

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 20 months

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

20 months

2차 결과 측정

결과 측정
측정값 설명
기간
Resource outcomes:
기간: 20 months

Time taken to recruit participants: Reported in days

20 months
Resource outcomes:
기간: 20 months

Sample size calculation in number

20 months
Resource outcomes:
기간: 20 months

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

20 months
Resource outcomes:
기간: 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
기간: 20 months

Participants experience of the intervention

20 months
Exploratory endpoints/outcomes
기간: 20 months

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

20 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

  • 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

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2027년 3월 1일

기본 완료 (추정된)

2028년 11월 1일

연구 완료 (추정된)

2028년 11월 1일

연구 등록 날짜

최초 제출

2026년 10월 16일

QC 기준을 충족하는 최초 제출

2026년 11월 3일

처음 게시됨 (실제)

2026년 11월 10일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 10일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 3일

마지막으로 확인됨

2026년 11월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • SABPNHS

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아니요

IPD 계획 설명

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약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

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미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .