PsychosisNCT04310475
Virtual Reality Assisted CBT for Social Difficulties: a Feasibility Study in Early Intervention for Psychosis Services
A study testing Virtual reality assisted CBT in people with Psychosis and Social Behavior, run by King's College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psychosis, Social Behavior, Paranoia
- What is being tested?
- Virtual reality assisted CBT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Aug 2019to 1 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Institute of Psychiatry, Psychology and Neuroscience, King's College London
London
About this study
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.
Read the 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.
- Conditions
- Psychosis, Social Behavior, Paranoia, Social Anxiety
- Being tested
- Virtual reality assisted CBT
- Medical subject headings
- Psychotic Disorders, Social Behavior, Paranoid Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality assisted CBTOther
This study uses virtual reality technology to assist cognitive behavioural therapy for social difficulties in people with first episode psychosis.
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment | Experimental | This is a case series Receives: Other: Virtual reality assisted CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment and retention
To assess feasibility and acceptability data will be collected regarding the number of people approached, engaged, dropped out, completed the intervention
Measured: From start of study until completion of recruitment, approximately 8 months
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.
Measured: From start of study until completion of intervention, approximately 10 months
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.
Measured: From start of study until completion of intervention, approximately 10 months
Secondary outcomes (10)
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).
Measured: Start and end of each individual intervention at approximately 10-16 week interval, up to 10 months
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).
Measured: Start and end of each individual intervention at approximately 10-16 week interval, up to 10 months
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).
Measured: Start and end of each individual intervention at approximately 10-16 week interval, up to 10 months
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).
Measured: Start and end of each individual intervention at approximately 10-16 week interval, up to 10 months
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).
Measured: Start and end of each individual intervention at approximately 10-16 week interval, up to 10 months
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).
Measured: Start and end of each individual intervention at approximately 10-16 week interval, up to 10 months
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).
Measured: Start and end of each individual intervention at approximately 10-16 week interval, up to 10 months
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).
Measured: Start and end of each individual intervention at approximately 10-16 week interval, up to 10 months
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.
Measured: Start, middle and end of each individual intervention within approximately 10-16 week window, up to 10 months
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.
Measured: At completion of each intervention or when clients drop out from the study, up to 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start23 Aug 2019
- Primary completion1 Oct 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Case series, feasibility study
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Lucia Valmaggia, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04310475
- Sponsor's protocol ID
- 255964
- Status last verified
- Mar 2022
- First submitted
- 10 Mar 2020
- Last updated
- 8 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Assisted CBT for Social Difficulties: a Feasibility Study in Early Intervention for Psychosis Services
- ClinicalTrials.gov ID
- NCT04310475
- Acronym / sponsor ID
- 255964
- Conditions
- Psychosis, Social Behavior, Paranoia, Social Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 23 Aug 2019 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 17 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Case series, feasibility study
| Arm | Type | Receives |
|---|---|---|
| Active Treatment | Experimental | Other: Virtual reality assisted CBTThis is a case series |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality assisted CBTThis study uses virtual reality technology to assist cognitive behavioural therapy for social difficulties in people with first episode psychosis. | Other | Active Treatment |
Primary outcome
Recruitment and retention
Time frame: From start of study until completion of recruitment, approximately 8 months
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
Time frame: From start of study until completion of intervention, approximately 10 months
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
Time frame: From start of study until completion of intervention, approximately 10 months
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.
10 secondary outcomes
Pre and post therapy psychometric assessment - mood
Time frame: Start and end of each individual intervention at approximately 10-16 week interval, up to 10 months
Pre and post therapy psychometric assessment - anxiety
Time frame: Start and end of each individual intervention at approximately 10-16 week interval, up to 10 months
Pre and post therapy psychometric assessment - social anxiety 1
Time frame: Start and end of each individual intervention at approximately 10-16 week interval, up to 10 months
Pre and post therapy psychometric assessment - social anxiety 2
Time frame: Start and end of each individual intervention at approximately 10-16 week interval, up to 10 months
Pre and post therapy psychometric assessment - paranoid thoughts
Time frame: Start and end of each individual intervention at approximately 10-16 week interval, up to 10 months
Pre and post therapy psychometric assessment - interpersonal sensitivity
Time frame: Start and end of each individual intervention at approximately 10-16 week interval, up to 10 months
Pre and post therapy psychometric assessment - symptom related distress
Time frame: Start and end of each individual intervention at approximately 10-16 week interval, up to 10 months
Pre and post therapy psychometric assessment - loneliness
Time frame: Start and end of each individual intervention at approximately 10-16 week interval, up to 10 months
Progress towards individualized SMART goal
Time frame: Start, middle and end of each individual intervention within approximately 10-16 week window, up to 10 months
Adverse effects
Time frame: At completion of each intervention or when clients drop out from the study, up to 10 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality assisted CBT in people with Psychosis and Social Behavior, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment and retention (time frame: From start of study until completion of recruitment, approximately 8 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2022.