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

28 maj 2026 uppdaterad 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

15

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

  • Storbritannien
    • Greater London
      • London, Greater London, Storbritannien, SE5 8AF
        • Institute of Psychiatry, Psychology & Neuroscience (IoPPN), King's College London
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Övrig: MANOEUVRE therapy
Övrig: MANOEUVRE therapy
Virtual reality assisted psychological therapy for emotion regulation difficulties

Vad mäter studien?

Primära resultatmått

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

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
DBT Ways of Coping Checklist - DBT Skills Subscale
Tidsram: 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)
Tidsram: Pre therapy, immediately after therapy, 3 month follow up
Psychological distress
Pre therapy, immediately after therapy, 3 month follow up
Goal Attainment Scaling (GAS)
Tidsram: 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)
Tidsram: Pre therapy, immediately after therapy, 3 month follow up
Quality of life
Pre therapy, immediately after therapy, 3 month follow up

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

King's College London

Samarbetspartners

South London and Maudsley NHS Foundation Trust

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 september 2027

Primärt slutförande (Beräknad)

1 maj 2028

Avslutad studie (Beräknad)

1 november 2028

Studieregistreringsdatum

Först inskickad

20 maj 2026

Först inskickad som uppfyllde QC-kriterierna

28 maj 2026

Första postat (Faktisk)

3 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

3 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

28 maj 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • NIHR305247

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

Individual participant data that underlie the results after deidentification

Tidsram för IPD-delning

After publication

Kriterier för IPD Sharing Access

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

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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