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
状態
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Tayeem Pathan, MBBS MSC
- 電話番号:0044-01483448020
- メール:tayeem.pathan@sabp.nhs.uk
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
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
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) :
|
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)
|
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)
|
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)
|
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)
|
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)
|
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)
|
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
出版物と役立つリンク
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
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
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最初の投稿 (実際)
学習記録の更新
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その他の研究ID番号
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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?
IPD プランの説明
Consent not given
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