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

NCT07623928 | Not Yet Recruiting

• 1 other identifier: NIHR305247
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  Self reported emotion regulation difficulties

  Pre therapy, immediately after therapy, 3 month follow up

Other Outcomes (4)

• DBT Ways of Coping Checklist - DBT Skills Subscale

  Pre therapy, immediately after therapy, follow up

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

  Pre therapy, immediately after therapy, 3 month follow up

• Goal Attainment Scaling (GAS)

  Pre therapy, immediately after therapy, 3 month follow up

Study Arms (1)

MANOEUVRE therapy

OTHER

Other: MANOEUVRE therapy

Interventions

MANOEUVRE therapy OTHER

Virtual reality assisted psychological therapy for emotion regulation difficulties

MANOEUVRE therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• King's College London: lead
• South London and Maudsley NHS Foundation Trust: collaborator

Study Sites (1)

Institute of Psychiatry, Psychology & Neuroscience (IoPPN), King's College London

London, Greater London, SE5 8AF, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 35130354 BACKGROUND

• 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.

  PMID: 31661593 BACKGROUND

MeSH Terms

Conditions

Psychotic Disorders; Schizophrenia; Emotional Regulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Self-Control; Social Behavior; Behavior

Study Officials

• Professor Dame Til Wykes

  King's College London

  STUDY CHAIR

• Professor Matteo Cella

  King's College London

  STUDY DIRECTOR

• Dr Caroline Lawlor

  King's College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Caroline Lawlor

CONTACT

+44 7388 960630; caroline.lawlor@kcl.ac.uk

Professor Dame Til Wykes

CONTACT

+44 20 7848 0596; Til.Wkyes@kcl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: June 3, 2026
• Study Start (Estimated): September 1, 2027
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: After publication
• Access Criteria: The final anonymised study dataset will be available to other researchers at the end of the programme provided that does not compromise confidentiality.

Locations

GB (1)