- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07928440
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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Tayeem Pathan, MBBS MSC
- Número de teléfono: 0044-01483448020
- Correo electrónico: tayeem.pathan@sabp.nhs.uk
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 20 months
|
AAQoL (Adult ADHD Quality of life)
|
20 months
|
|
The study also aims to compare pre and post iMBT group clinical outcome data.
Periodo de tiempo: 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.
Periodo de tiempo: 20 months
|
UPPS (Impulsive behaviour scale)
|
20 months
|
|
The study also aims to compare pre and post iMBT group clinical outcome data.
Periodo de tiempo: 20 months
|
MENT-S (The mentalization scale)
|
20 months
|
|
The study also aims to compare pre and post iMBT group clinical outcome data.
Periodo de tiempo: 20 months
|
RFQ-8 (Reflective function Questionnaire)
|
20 months
|
|
The study also aims to compare pre and post iMBT group clinical outcome data.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 20 months
|
Acceptability of the intervention to participants: through interview of the participants. Will be reported as themes and quotes from participants. |
20 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Resource outcomes:
Periodo de tiempo: 20 months
|
Time taken to recruit participants: Reported in days |
20 months
|
|
Resource outcomes:
Periodo de tiempo: 20 months
|
Sample size calculation in number |
20 months
|
|
Resource outcomes:
Periodo de tiempo: 20 months
|
Data collection success (percentage of participants completed the outcome measures) |
20 months
|
|
Resource outcomes:
Periodo de tiempo: 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
Periodo de tiempo: 20 months
|
Participants experience of the intervention |
20 months
|
|
Exploratory endpoints/outcomes
Periodo de tiempo: 20 months
|
Facilitators' and Co-facilitators' experience of the intervention. |
20 months
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- 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
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- SABPNHS
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Consent not given
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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