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

Official title

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

Overview

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

• Other MANOEUVRE therapy
  Virtual reality assisted psychological therapy for emotion regulation difficulties

Primary outcome measures

• Difficulties in Emotion Regulation Scale 16 item version (DERS-16) [Time frame: Pre therapy, immediately after therapy, 3 month follow up]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United Kingdom · 1 center

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

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. PMID 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. PMID 31661593

Identifiers

NCT: NCT07623928 · NIHR305247

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗