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Developing a Virtual Reality-assisted Intervention for Emotion Regulation Difficulties in Psychosis (MANOEUVRE)

28. mai 2026 oppdatert av: King's College London

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

15

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Storbritannia
    • Greater London
      • London, Greater London, Storbritannia, SE5 8AF
        • Institute of Psychiatry, Psychology & Neuroscience (IoPPN), King's College London
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: MANOEUVRE therapy
Annen: MANOEUVRE therapy
Virtual reality assisted psychological therapy for emotion regulation difficulties

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Difficulties in Emotion Regulation Scale 16 item version (DERS-16)
Tidsramme: Pre therapy, immediately after therapy, 3 month follow up
Self reported emotion regulation difficulties
Pre therapy, immediately after therapy, 3 month follow up

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
DBT Ways of Coping Checklist - DBT Skills Subscale
Tidsramme: Pre therapy, immediately after therapy, follow up
Adaptive use of emotion regulation skills
Pre therapy, immediately after therapy, follow up
Clinical Outcomes in Routine Evaluation-10 item version (CORE-10)
Tidsramme: Pre therapy, immediately after therapy, 3 month follow up
Psychological distress
Pre therapy, immediately after therapy, 3 month follow up
Goal Attainment Scaling (GAS)
Tidsramme: Pre therapy, immediately after therapy, 3 month follow up
Personal recovery goal achievement
Pre therapy, immediately after therapy, 3 month follow up
Recovering Quality of Life (ReQoL-10)
Tidsramme: Pre therapy, immediately after therapy, 3 month follow up
Quality of life
Pre therapy, immediately after therapy, 3 month follow up

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

King's College London

Samarbeidspartnere

South London and Maudsley NHS Foundation Trust

Etterforskere

  • Studiestol: Professor Dame Til Wykes, King's College London
  • Studieleder: Professor Matteo Cella, King's College London
  • Hovedetterforsker: Dr Caroline Lawlor, King's College London

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. september 2027

Primær fullføring (Antatt)

1. mai 2028

Studiet fullført (Antatt)

1. november 2028

Datoer for studieregistrering

Først innsendt

20. mai 2026

Først innsendt som oppfylte QC-kriteriene

28. mai 2026

Først lagt ut (Faktiske)

3. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • NIHR305247

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Individual participant data that underlie the results after deidentification

IPD-delingstidsramme

After publication

Tilgangskriterier for IPD-deling

The final anonymised study dataset will be available to other researchers at the end of the programme provided that does not compromise confidentiality.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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