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.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Dr Caroline Lawlor
- Telefonní číslo: +44 7388 960630
- E-mail: caroline.lawlor@kcl.ac.uk
Studijní záloha kontaktů
- Jméno: Professor Dame Til Wykes
- Telefonní číslo: +44 20 7848 0596
- E-mail: Til.Wkyes@kcl.ac.uk
Studijní místa
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Greater London
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London, Greater London, Spojené království, SE5 8AF
- Institute of Psychiatry, Psychology & Neuroscience (IoPPN), King's College London
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Kontakt:
- Dr Caroline Lawlor
- Telefonní číslo: +44 7388960630
- E-mail: caroline.lawlor@kcl.ac.uk
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Jiný: MANOEUVRE therapy
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Virtual reality assisted psychological therapy for emotion regulation difficulties
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Difficulties in Emotion Regulation Scale 16 item version (DERS-16)
Časové okno: 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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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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DBT Ways of Coping Checklist - DBT Skills Subscale
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Studijní židle: Professor Dame Til Wykes, King's College London
- Ředitel studie: Professor Matteo Cella, King's College London
- Vrchní vyšetřovatel: Dr Caroline Lawlor, King's College London
Publikace a užitečné odkazy
Obecné publikace
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- NIHR305247
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Časový rámec sdílení IPD
Kritéria přístupu pro sdílení IPD
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