Developing a Virtual Reality-assisted Intervention for Emotion Regulation Difficulties in Psychosis (MANOEUVRE)
MANaging emOtions in Everyday Life Using Virtual REality (MANOEUVRE): Developing a VR-assisted Intervention for Emotion Regulation Difficulties in Psychosis
Supporting people with psychosis to manage their emotions using virtual reality
Many people who have experienced psychosis feel overwhelmed by their emotions. Emotions get in the way of doing what matters to them. They want support to manage emotions differently. There is evidence that people with psychosis find talking therapies that teach skills for managing emotions helpful. People said it helped them to understand and manage their emotions. However, they also wanted more help to apply skills they learned to their lives.
It is hard to help people to use therapy skills in real-life situations. Therapists cannot be present when the skills are needed. One solution is to use virtual reality (VR) to bridge the gap between the clinic and real-life. VR involves using a headset to see and hear a very life-like computer-generated simulation of everyday life situations. People with psychosis find VR therapies engaging and helpful. It can feel safer to try things out in VR.
Guided by the feedback of people with psychosis, this research will evaluate a novel therapy to help people with psychosis manage their emotions. Face-to- face therapy will be combined with VR so that people can practice emotion regulation skills safely with "live" coaching from a therapist. This should support people to use these skills when they need them.
Fifteen people with psychosis will be offered the therapy. Everyone will be asked what they think of it and complete questionnaires before and after therapy to see what impact it had on their lives.
A lived experience advisory group will support all aspects of the research process.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Background Many people with psychosis report difficulties understanding and managing their emotions (emotion regulation difficulties), yet evidence-based interventions are lacking. Brief interventions that teach emotion regulation skills show promise but service users report wanting additional support to apply what they have learned in therapy to their lives.
Aim: To test the initial feasibility and acceptability of a VR-assisted therapy (called MANaging emOtions in Everyday life Using Virtual REality; MANOEUVRE) for emotion regulation difficulties in psychosis
Methods A mixed methods case series will be undertaken. The study will recruit people with psychosis from NHS community care teams (in England). Assessments will be at baseline, post therapy and 3-month follow up. Feasibility and acceptability of a future trial will be assessed based on uptake/ recruitment, data completeness and qualitative feedback. Feasibility and assessment of the therapy will be assessed based on adherence, acceptability (sessional feedback ratings, qualitative interview feedback, side effect and satisfaction ratings), safety (adverse effects), implementation resources and fidelity.
Participants will complete measures of emotion regulation difficulties, adaptive emotion regulation skill use, psychological distress, personal recovery goal achievement and quality of life. To assess feasibility, individual-level changes will be calculated using the reliable change index to assess whether changes are more likely to reflect measurement error or actual clinical change. Group-level changes will be assessed using means and standard deviations and effect sizes (Cohen's d) with confidence intervals . A post therapy semi-structured interview will explore participants' experience of receiving MANOEUVRE.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Dr Caroline Lawlor
- Número de teléfono: +44 7388 960630
- Correo electrónico: caroline.lawlor@kcl.ac.uk
Copia de seguridad de contactos de estudio
- Nombre: Professor Dame Til Wykes
- Número de teléfono: +44 20 7848 0596
- Correo electrónico: Til.Wkyes@kcl.ac.uk
Ubicaciones de estudio
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Greater London
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London, Greater London, Reino Unido, SE5 8AF
- Institute of Psychiatry, Psychology & Neuroscience (IoPPN), King's College London
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Contacto:
- Dr Caroline Lawlor
- Número de teléfono: +44 7388960630
- Correo electrónico: caroline.lawlor@kcl.ac.uk
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Currently under the care of South London and Maudsley (SLaM) National Health Service (NHS) outpatient services.
- Clinical diagnosis of psychosis (schizophrenia spectrum disorder) (as assessed by their clinical team)
- Willing to have the interview audio recorded (if taking part in post therapy interview)
- Willing and able to provide informed consent to participate in the study (as assessed by their clinical team)
Exclusion Criteria:
- Clinical presentation (e.g., immediate serious risk to self) (as assessed by their clinical team)
- History of photosensitive epilepsy
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 |
|---|---|
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Otro: MANOEUVRE therapy
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Virtual reality assisted psychological therapy for emotion regulation difficulties
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Difficulties in Emotion Regulation Scale 16 item version (DERS-16)
Periodo de tiempo: Pre therapy, immediately after therapy, 3 month follow up
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Self reported emotion regulation difficulties
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Pre therapy, immediately after therapy, 3 month follow up
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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DBT Ways of Coping Checklist - DBT Skills Subscale
Periodo de tiempo: Pre therapy, immediately after therapy, follow up
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Adaptive use of emotion regulation skills
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Pre therapy, immediately after therapy, follow up
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Clinical Outcomes in Routine Evaluation-10 item version (CORE-10)
Periodo de tiempo: Pre therapy, immediately after therapy, 3 month follow up
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Psychological distress
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Pre therapy, immediately after therapy, 3 month follow up
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Goal Attainment Scaling (GAS)
Periodo de tiempo: Pre therapy, immediately after therapy, 3 month follow up
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Personal recovery goal achievement
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Pre therapy, immediately after therapy, 3 month follow up
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Recovering Quality of Life (ReQoL-10)
Periodo de tiempo: Pre therapy, immediately after therapy, 3 month follow up
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Quality of life
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Pre therapy, immediately after therapy, 3 month follow up
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Professor Dame Til Wykes, King's College London
- Director de estudio: Professor Matteo Cella, King's College London
- Investigador principal: Dr Caroline Lawlor, King's College London
Publicaciones y enlaces útiles
Publicaciones Generales
- Lawlor C, Hepworth C, Smallwood J, Carter B, Jolley S. Self-reported emotion regulation difficulties in people with psychosis compared with non-clinical controls: A systematic literature review. Clin Psychol Psychother. 2020 Mar;27(2):107-135. doi: 10.1002/cpp.2408. Epub 2020 Feb 12.
- Lawlor C, Vitoratou S, Duffy J, Cooper B, De Souza T, Le Boutillier C, Carter B, Hepworth C, Jolley S. Managing emotions in psychosis: Evaluation of a brief DBT-informed skills group for individuals with psychosis in routine community services. Br J Clin Psychol. 2022 Sep;61(3):735-756. doi: 10.1111/bjc.12359. Epub 2022 Feb 7.
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
- NIHR305247
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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