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Virtual Reality Assisted CBT for Social Difficulties: a Feasibility Study in Early Intervention for Psychosis Services

Primary Purpose

Psychosis, Social Behavior, Paranoia

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Virtual reality assisted CBT
Sponsored by
King's College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The participant must be under the care of an approved research site throughout the period of the study i.e. local early intervention for psychosis clinical team
  • The participant must be aged 18-65 and speak English to a conversational level.
  • The participant must have experienced or currently be experiencing psychosis, as defined by ICD-10 and DSM-V criteria.
  • The participant must have the capacity to consent to the study
  • The participant should be experiencing difficulties in social situations (e.g. due to paranoia, social anxiety, poor social skills, low mood or lack of social motivation)

Exclusion Criteria:

  • The participant must not have a history of epilepsy OR photosensitivity (any other comorbidity is fine).
  • The participant must not currently be in receipt of another psychological therapy at the time of the study (before or after the study is fine).

Sites / Locations

  • Institute of Psychiatry, Psychology and Neuroscience, King's College London

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Active Treatment

Arm Description

This is a case series

Outcomes

Primary Outcome Measures

Recruitment and retention
To assess feasibility and acceptability data will be collected regarding the number of people approached, engaged, dropped out, completed the intervention
Qualitative feedback from clients and therapists about their experiences
To assess feasibility and acceptability feedback from clients and therapists about the experience of the receiving and/or delivering the intervention will be regularly sought via interview.
Study resources
To assess feasibility and acceptability the resources required for the intervention will be recorded (e.g. from training and supervising therapists, to room space, technological kit and support required etc.) as observations.

Secondary Outcome Measures

Pre and post therapy psychometric assessment - mood
To assess the potential intervention efficacy, psychometric data will be collected pre and post intervention to assess change in mood before and after receiving the intervention using the PHQ-8 (a self report questionnaire measure of depression).
Pre and post therapy psychometric assessment - anxiety
To assess the potential intervention efficacy, psychometric data will be collected pre and post intervention to assess change in anxiety before and after receiving the intervention using the GAD-7 (a self report questionnaire measure of generalised anxiety).
Pre and post therapy psychometric assessment - social anxiety 1
To assess the potential intervention efficacy, psychometric data will be collected pre and post intervention to assess change in social anxiety before and after receiving the intervention using the Social Anxiety and Distress Scale (SADS; a self report questionnaire measure of social anxiety and distress).
Pre and post therapy psychometric assessment - social anxiety 2
To assess the potential intervention efficacy, psychometric data will be collected pre and post intervention to assess change in social anxiety before and after receiving the intervention using the Brief Fear of Negative Evaluation (BFNE; a self report questionnaire measure of fear of negative evaluation in the context of social anxiety).
Pre and post therapy psychometric assessment - paranoid thoughts
To assess the potential intervention efficacy, psychometric data will be collected pre and post intervention to assess change in paranoid thoughts before and after receiving the intervention using the Green Paranoid Thoughts Scale (GPTS; a self report questionnaire measure of paranoid thoughts).
Pre and post therapy psychometric assessment - interpersonal sensitivity
To assess the potential intervention efficacy, psychometric data will be collected pre and post intervention to assess change in interpersonal sensitivity before and after receiving the intervention using the Interpersonal Sensitivity Measure (IPSM; a self report questionnaire measure of interpersonal sensitivity).
Pre and post therapy psychometric assessment - symptom related distress
To assess the potential intervention efficacy, psychometric data will be collected pre and post intervention to assess change in symptom related distress before and after receiving the intervention using the CORE-10 (a self report questionnaire measure of symptom related distress).
Pre and post therapy psychometric assessment - loneliness
To assess the potential intervention efficacy, psychometric data will be collected pre and post intervention to assess change in experience of loneliness before and after receiving the intervention using the UCLA Loneliness scale (UCLAL-20; a self report questionnaire measure of interpersonal sensitivity).
Progress towards individualized SMART goal
To assess the potential intervention efficacy, clients will set a SMART goal to work on during therapy. Progress towards achieving this goal will be assessed using scaling questions throughout therapy.
Adverse effects
To assess for any potential adverse effects of the intervention, e.g. increase in symptoms/ reduction in functioning, clients will be asked to complete a questionnaire assessing this at the end of the intervention or if they drop out from the study. This questionnaire has been co-developed with a peer researcher for the purposes of the study.

Full Information

First Posted
March 10, 2020
Last Updated
March 31, 2022
Sponsor
King's College London
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1. Study Identification

Unique Protocol Identification Number
NCT04310475
Brief Title
Virtual Reality Assisted CBT for Social Difficulties: a Feasibility Study in Early Intervention for Psychosis Services
Official Title
Virtual Reality Assisted CBT for Social Difficulties: a Feasibility Study in Early Intervention for Psychosis Services
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
August 23, 2019 (Actual)
Primary Completion Date
October 1, 2020 (Actual)
Study Completion Date
October 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King's College London

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
People experiencing psychosis might find social interactions stressful and avoid them. This can result in isolation and can affect relationships, employment and quality of life. Improving social functioning is a really important aspect of recovery. Facing social situations after the first episode of psychosis can be very difficult and provoke intense anxiety. However, research has shown that the earlier intervention is offered, the better the outcome. Therefore, improving therapies for people experiencing their first episode of psychosis is a key target for research. Virtual Reality presents a unique opportunity to bring real-life-type environments into a therapy session to help people to overcome their distress in social situations and make them feel less anxious. Virtual Reality assisted Therapy (VRT) provides a 'safe space' to practice strategies and techniques to help people work towards improving their social functioning, build new ways of coping with stress and assist them in their recovery. The study uses a standard CBT model and integrates a Virtual Reality environment into it to support exposure and behavioural experiments for social difficulties, which are a key component of treatment.
Detailed Description
Participants will be offered up to 10 sessions including a pre and post assessment session. Each participant will set one or more SMART goals for therapy (e.g. be able to use public transport, attend a social gathering or to feel less anxious in social situations) which are worked on both in the therapy sessions and through homework tasks. This is a feasibility study. The aim is to recruit between 6-10 participants to pilot the VRT with. The results of this study will inform future research and practice, by helping to assess if service-users find the new VRT acceptable (e.g. recruitment, retention, drop out rates, participant experiences), and if it is effective (e.g. reduction in symptoms or distress, and improvement in social functioning). It is really important that the clinical care of anyone who chooses to participate in the study is not affected by their participation in this study. The researchers will work closely with clinical teams to ensure this. Clients who engage with the study will still be eligible for all aspects of TAU including psychological interventions, should this be appropriate. The VR technology and environment has been used extensively before in research studies, which have proved that it is safe and effective. However, it has not been used within the NHS context before or embedded within a therapy course before.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychosis, Social Behavior, Paranoia, Social Anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Case series, feasibility study
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Treatment
Arm Type
Experimental
Arm Description
This is a case series
Intervention Type
Other
Intervention Name(s)
Virtual reality assisted CBT
Intervention Description
This study uses virtual reality technology to assist cognitive behavioural therapy for social difficulties in people with first episode psychosis.
Primary Outcome Measure Information:
Title
Recruitment and retention
Description
To assess feasibility and acceptability data will be collected regarding the number of people approached, engaged, dropped out, completed the intervention
Time Frame
From start of study until completion of recruitment, approximately 8 months
Title
Qualitative feedback from clients and therapists about their experiences
Description
To assess feasibility and acceptability feedback from clients and therapists about the experience of the receiving and/or delivering the intervention will be regularly sought via interview.
Time Frame
From start of study until completion of intervention, approximately 10 months
Title
Study resources
Description
To assess feasibility and acceptability the resources required for the intervention will be recorded (e.g. from training and supervising therapists, to room space, technological kit and support required etc.) as observations.
Time Frame
From start of study until completion of intervention, approximately 10 months
Secondary Outcome Measure Information:
Title
Pre and post therapy psychometric assessment - mood
Description
To assess the potential intervention efficacy, psychometric data will be collected pre and post intervention to assess change in mood before and after receiving the intervention using the PHQ-8 (a self report questionnaire measure of depression).
Time Frame
Start and end of each individual intervention at approximately 10-16 week interval, up to 10 months
Title
Pre and post therapy psychometric assessment - anxiety
Description
To assess the potential intervention efficacy, psychometric data will be collected pre and post intervention to assess change in anxiety before and after receiving the intervention using the GAD-7 (a self report questionnaire measure of generalised anxiety).
Time Frame
Start and end of each individual intervention at approximately 10-16 week interval, up to 10 months
Title
Pre and post therapy psychometric assessment - social anxiety 1
Description
To assess the potential intervention efficacy, psychometric data will be collected pre and post intervention to assess change in social anxiety before and after receiving the intervention using the Social Anxiety and Distress Scale (SADS; a self report questionnaire measure of social anxiety and distress).
Time Frame
Start and end of each individual intervention at approximately 10-16 week interval, up to 10 months
Title
Pre and post therapy psychometric assessment - social anxiety 2
Description
To assess the potential intervention efficacy, psychometric data will be collected pre and post intervention to assess change in social anxiety before and after receiving the intervention using the Brief Fear of Negative Evaluation (BFNE; a self report questionnaire measure of fear of negative evaluation in the context of social anxiety).
Time Frame
Start and end of each individual intervention at approximately 10-16 week interval, up to 10 months
Title
Pre and post therapy psychometric assessment - paranoid thoughts
Description
To assess the potential intervention efficacy, psychometric data will be collected pre and post intervention to assess change in paranoid thoughts before and after receiving the intervention using the Green Paranoid Thoughts Scale (GPTS; a self report questionnaire measure of paranoid thoughts).
Time Frame
Start and end of each individual intervention at approximately 10-16 week interval, up to 10 months
Title
Pre and post therapy psychometric assessment - interpersonal sensitivity
Description
To assess the potential intervention efficacy, psychometric data will be collected pre and post intervention to assess change in interpersonal sensitivity before and after receiving the intervention using the Interpersonal Sensitivity Measure (IPSM; a self report questionnaire measure of interpersonal sensitivity).
Time Frame
Start and end of each individual intervention at approximately 10-16 week interval, up to 10 months
Title
Pre and post therapy psychometric assessment - symptom related distress
Description
To assess the potential intervention efficacy, psychometric data will be collected pre and post intervention to assess change in symptom related distress before and after receiving the intervention using the CORE-10 (a self report questionnaire measure of symptom related distress).
Time Frame
Start and end of each individual intervention at approximately 10-16 week interval, up to 10 months
Title
Pre and post therapy psychometric assessment - loneliness
Description
To assess the potential intervention efficacy, psychometric data will be collected pre and post intervention to assess change in experience of loneliness before and after receiving the intervention using the UCLA Loneliness scale (UCLAL-20; a self report questionnaire measure of interpersonal sensitivity).
Time Frame
Start and end of each individual intervention at approximately 10-16 week interval, up to 10 months
Title
Progress towards individualized SMART goal
Description
To assess the potential intervention efficacy, clients will set a SMART goal to work on during therapy. Progress towards achieving this goal will be assessed using scaling questions throughout therapy.
Time Frame
Start, middle and end of each individual intervention within approximately 10-16 week window, up to 10 months
Title
Adverse effects
Description
To assess for any potential adverse effects of the intervention, e.g. increase in symptoms/ reduction in functioning, clients will be asked to complete a questionnaire assessing this at the end of the intervention or if they drop out from the study. This questionnaire has been co-developed with a peer researcher for the purposes of the study.
Time Frame
At completion of each intervention or when clients drop out from the study, up to 10 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The participant must be under the care of an approved research site throughout the period of the study i.e. local early intervention for psychosis clinical team The participant must be aged 18-65 and speak English to a conversational level. The participant must have experienced or currently be experiencing psychosis, as defined by ICD-10 and DSM-V criteria. The participant must have the capacity to consent to the study The participant should be experiencing difficulties in social situations (e.g. due to paranoia, social anxiety, poor social skills, low mood or lack of social motivation) Exclusion Criteria: The participant must not have a history of epilepsy OR photosensitivity (any other comorbidity is fine). The participant must not currently be in receipt of another psychological therapy at the time of the study (before or after the study is fine).
Facility Information:
Facility Name
Institute of Psychiatry, Psychology and Neuroscience, King's College London
City
London
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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Virtual Reality Assisted CBT for Social Difficulties: a Feasibility Study in Early Intervention for Psychosis Services

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