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Not yet recruitingNCT07623928MANOEUVREUpdated Jun 3, 2026

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

An interventional study of MANOEUVRE therapy in Psychosis, SCHIZOPHRENIA 1 (Disorder) and Schizophrenia and Related Disorders, sponsored by King's College London. Not yet recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-03.

Sponsored by King's College London · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

Psychotic Disorders

1,626 studies on the registry are indexed under Psychotic Disorders; 293 are open to participants now.

This study's planned enrollment of 15 is below the median of 70 across 1,333 interventional studies indexed under Psychotic Disorders.

Browse Psychotic Disorders studies →

Lead sponsor

King's College London is the lead sponsor of 506 studies on the registry; 125 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • Clinical presentation (e.g., immediate serious risk to self) (as assessed by their clinical team)
  • History of photosensitive epilepsy
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • Other
    MANOEUVRE therapy

    Other: MANOEUVRE therapy

Interventions

  • OtherMANOEUVRE therapy

    Virtual reality assisted psychological therapy for emotion regulation difficulties

06

What researchers measure

Primary outcomes

  1. Difficulties in Emotion Regulation Scale 16 item version (DERS-16)

    Self reported emotion regulation difficulties

    Time frame: Pre therapy, immediately after therapy, 3 month follow up

Other outcomes

  1. DBT Ways of Coping Checklist - DBT Skills Subscale

    Adaptive use of emotion regulation skills

    Time frame: Pre therapy, immediately after therapy, follow up

  2. Clinical Outcomes in Routine Evaluation-10 item version (CORE-10)

    Psychological distress

    Time frame: Pre therapy, immediately after therapy, 3 month follow up

  3. Goal Attainment Scaling (GAS)

    Personal recovery goal achievement

    Time frame: Pre therapy, immediately after therapy, 3 month follow up

  4. Recovering Quality of Life (ReQoL-10)

    Quality of life

    Time frame: Pre therapy, immediately after therapy, 3 month follow up

07

Study locations

1 site
  • Institute of Psychiatry, Psychology & Neuroscience (IoPPN), King's College London
    London, Greater London SE5 8AF, United Kingdom
08

References and documents

Publications

  • 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. PubMed 35130354 ↗
  • 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. PubMed 31661593 ↗

Individual participant data

Plan to share: Yes — Individual participant data that underlie the results after deidentification

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07623928
Lead sponsor
King's College London
Collaborators
South London and Maudsley NHS Foundation Trust
Responsible party
Sponsor
First posted
Jun 3, 2026
Start date
Sep 1, 2027 (estimated)
Primary completion
May 1, 2028 (estimated)
Completion
Nov 1, 2028 (estimated)
Last update
Jun 3, 2026

Study contacts

Dr Caroline Lawlor
Contact
caroline.lawlor@kcl.ac.uk
+44 7388 960630
Professor Dame Til Wykes
Contact
Til.Wkyes@kcl.ac.uk
+44 20 7848 0596
Professor Dame Til Wykes
study chair · King's College London
Professor Matteo Cella
study director · King's College London
Dr Caroline Lawlor
principal investigator · King's College London

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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