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

MANaging emOtions in Everyday Life Using Virtual REality (MANOEUVRE): Developing a VR-assisted Intervention for Emotion Regulation Difficulties in Psychosis

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07623928
Acronym
MANOEUVRE
Enrollment
15
Registered
2026-06-03
Start date
2027-09-01
Completion date
2028-11-01
Last updated
2026-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychosis, SCHIZOPHRENIA 1 (Disorder), Schizophrenia and Related Disorders

Keywords

Emotion regulation, Psychosis, Virtual reality, Schizophrenia spectrum disorders, Virtual reality exposure therapy, Psychotherapy, Dialectical behaviour therapy

Brief summary

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.

Detailed description

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.

Interventions

OTHERMANOEUVRE therapy

Virtual reality assisted psychological therapy for emotion regulation difficulties

Sponsors

King's College London
Lead SponsorOTHER
South London and Maudsley NHS Foundation Trust
CollaboratorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Difficulties in Emotion Regulation Scale 16 item version (DERS-16)Pre therapy, immediately after therapy, 3 month follow upSelf reported emotion regulation difficulties

Countries

United Kingdom

Contacts

CONTACTDr Caroline Lawlor
caroline.lawlor@kcl.ac.uk+44 7388 960630
CONTACTProfessor Dame Til Wykes
Til.Wkyes@kcl.ac.uk+44 20 7848 0596
STUDY_CHAIRProfessor Dame Til Wykes

King's College London

STUDY_DIRECTORProfessor Matteo Cella

King's College London

PRINCIPAL_INVESTIGATORDr Caroline Lawlor

King's College London

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 4, 2026