Visual HallucinationsNCT02782507
Cognitive Therapy for Distressing Visual Hallucinations: A Pilot Study
An observational study of Visual Hallucinations and Psychotic Disorders, run by Newcastle University at 1 site in United Kingdom.
Trial summary
The study is a pilot study of Cognitive therapy for people with psychosis who have distressing visual hallucinations. The aim is to evaluate whether this is an acceptable, feasible and effective treatment. This is a pilot study and there is no randomisation to either CBT or treatment as usual (TAU). Read more about this study
- Who is it for?
- Ages 18 to 38 years
- Conditions the study is for
- Visual Hallucinations, Psychotic Disorders
- What is being tested?
- CBT for Distressing visual hallucinations
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 7 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2012to Dec 2013
- Phase
- Observational
- 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 38 years
- All sexes
- No healthy volunteers
- Adult
Study population: People in Early Intervention in Psychosis services who are reporting distressing visual hallucinations in the past month.
Who may be able to join
- Meet entry criteria for Early Intervention in Psychosis (EIP) services
- Distressing visual hallucinations
- Age 18-38 years (the usual upper range of the EIP services)
Who cannot join
- Organic brain disease including dementia, epileptic psychosis, head injury (may be alternative cause of symptoms, or impair cognitive function and ability to do CBT)
- Primary diagnosis of drug or alcohol misuse (as above)
- Impaired intellect severe enough to interfere with ratings (as above)
- In-patient/acute psychiatric care needed at baseline assessment (patients must be well enough to engage in out-patient CBT)
- Previous CBT for psychosis (those previously exposed to the CBT model may be more likely to respond to CBT)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Early Intervention in Psychosis service
Sunderland, Tyne and Wear, SR5 1NB
About this study
The study is a pilot study of Cognitive therapy for people with psychosis who have distressing visual hallucinations. The aim is to evaluate whether this is an acceptable, feasible and effective treatment. This is a pilot study and there is no randomisation to either CBT or treatment as usual (TAU). If a participant is allocated to the cognitive therapy plus TAU condition then the participant will meet with a therapist on initially a weekly basis and receive up to 8 sessions of CBT over a 2 month period. The participant will also have regular assessments conducted by a researcher who is independent to the treatment group. It is predicted that those people receiving CBT will improve on measures of symptoms, and particularly for measures of visual hallucinations.
Read the detailed description
Cognitive behavioural therapy (CBT) has been proven to be effective in helping people with distressing psychotic symptoms such as auditory hallucinations or upsetting delusional beliefs. While the majority of hallucinations reported in psychotic disorders are auditory, visual hallucinations (VH) have been reported in 16%-72% of people with psychotic disorders like schizophrenia and schizoaffective disorder. VH appear to be associated with particularly high levels of distress, and impairment. The global severity of illness was significantly higher in people with schizophrenia and VH, as compared to those people without VH. Whilst antipsychotic medication is the first line of treatment for psychotic symptoms like VH, there is evidence that many service users choose to refuse or discontinue their pharmacological treatment. For example, the largest trial to compare atypical antipsychotics found that 74% of patients with a diagnosis of schizophrenia discontinued their medication over 18 months. Hence, there is a need to develop a range of effective treatments. Despite its value in treating auditory hallucinations, at present there is no specific CBT treatment for VH.
We developed a cognitive behavioural model for visual hallucinations. This model has been tested in a recent study of 15 people with psychosis and distressing visual hallucinations which found that it was not the presence of the visual experience per se that led to the distress but the appraisal of it (as being a threat to psychological or physical wellbeing). Such appraisals are targeted in CBT for auditory hallucinations.
The aim of this research is to assess the value of a manualised cognitive behavioural intervention for distressing visual hallucinations by establishing if it reduces distress and disability. The aim is to determine the acceptability of the treatment package, feasibility of recruitment, the ability to deliver the treatment manual as intended, retention in the treatment, a preliminary estimate of effect size and maintenance of any gains at a brief follow up.
- Conditions
- Visual Hallucinations, Psychotic Disorders
- Being tested
- CBT for Distressing visual hallucinations
- Keywords
- pilot study, CBT trial
- Medical subject headings
- Hallucinations, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT for Distressing visual hallucinationsBehavioural
Also called Cognitive Behavioural therapy for visual hallucinations
Eight to ten sessions of manualised CBT for distressing visual hallucinations based on existing treatment manuals (ie. Kingdon \& Turkington, 2004, Morrison et al., 2005), delivered over 8 to 12 weeks by CBT therapists.
Subjects will continue to receive treatment as usual throughout the therapy period and will receive appropriate prescription of medication if requested or clinically indicated.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in distress of visual hallucinations as assessed by the Psychotic symptoms rating scale for hallucinations (PSYRATS).
The PSYRATS measures distress, conviction and preoccupation and impact of life of symptoms such as voices or delusions. It has been adapted to be relevant to visual hallucinations.
Measured: change pre to post intervention which will be on average 3 months
Secondary outcomes (2)
Change from baseline on measure of depression (Beck Depression Inventory)
The BDI is a short, reliable, widely used measure of depression/low mood. It is a self report measure and participants will be asked to complete it before and after the intervention
Measured: Baseline and at three months
Change from baseline on measure of symptoms of psychosis as measured by he Schizophrenia Change Scale (SCS). The SCS is a subscale of the Comprehensive Psychopathological Rating Scale (CPRS), (Montgomery, Taylor, & Montgomery, 1978)
The SCS is a short, reliable, widely used measure of symptoms of psychosis. It is a interview based measure and participants will be asked to complete it before and after the intervention
Measured: baseline and at three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2016 (estimated)
- Study startJan 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual HallucinationsStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Newcastle University
- Sponsor type
- University, hospital or other
- Collaborators
- Northumberland, Tyne and Wear NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Robert Dudley, Ph.D, Principal investigator, Newcastle University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02782507
- Sponsor's protocol ID
- FSF 2010 / 11
- Status last verified
- Oct 2017
- First submitted
- 19 Jun 2013
- Last updated
- 31 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: The findings are shared with the individual participants and an anonymised version of the material is to be submitted for publication. The participants have consented to the sharing of anonymised material in this format.
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Therapy for Distressing Visual Hallucinations: A Pilot Study
- ClinicalTrials.gov ID
- NCT02782507
- Acronym / sponsor ID
- FSF 2010 / 11
- Conditions
- Visual Hallucinations, Psychotic Disorders
- Keywords
- pilot study, CBT trial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Newcastle UniversityUniversity, hospital or other
- Collaborators
- Northumberland, Tyne and Wear NHS Foundation Trust
- Study start
- Jan 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 25 May 2016 (estimated)
- 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.
The study is a pilot study of Cognitive therapy for people with psychosis who have distressing visual hallucinations. The aim is to evaluate whether this is an acceptable, feasible and effective treatment. This is a pilot study and there is no randomisation to either CBT or treatment as usual (TAU). If a participant is allocated to the cognitive therapy plus TAU condition then the participant will meet with a therapist on initially a weekly basis and receive up to 8 sessions of CBT over a 2 month period. The participant will also have regular assessments conducted by a researcher who is independent to the treatment group. It is predicted that those people receiving CBT will improve on measures of symptoms, and particularly for measures of visual hallucinations.
Detailed description
Cognitive behavioural therapy (CBT) has been proven to be effective in helping people with distressing psychotic symptoms such as auditory hallucinations or upsetting delusional beliefs. While the majority of hallucinations reported in psychotic disorders are auditory, visual hallucinations (VH) have been reported in 16%-72% of people with psychotic disorders like schizophrenia and schizoaffective disorder. VH appear to be associated with particularly high levels of distress, and impairment. The global severity of illness was significantly higher in people with schizophrenia and VH, as compared to those people without VH. Whilst antipsychotic medication is the first line of treatment for psychotic symptoms like VH, there is evidence that many service users choose to refuse or discontinue their pharmacological treatment. For example, the largest trial to compare atypical antipsychotics found that 74% of patients with a diagnosis of schizophrenia discontinued their medication over 18 months. Hence, there is a need to develop a range of effective treatments. Despite its value in treating auditory hallucinations, at present there is no specific CBT treatment for VH.
We developed a cognitive behavioural model for visual hallucinations. This model has been tested in a recent study of 15 people with psychosis and distressing visual hallucinations which found that it was not the presence of the visual experience per se that led to the distress but the appraisal of it (as being a threat to psychological or physical wellbeing). Such appraisals are targeted in CBT for auditory hallucinations.
The aim of this research is to assess the value of a manualised cognitive behavioural intervention for distressing visual hallucinations by establishing if it reduces distress and disability. The aim is to determine the acceptability of the treatment package, feasibility of recruitment, the ability to deliver the treatment manual as intended, retention in the treatment, a preliminary estimate of effect size and maintenance of any gains at a brief follow up.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 38 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- People in Early Intervention in Psychosis services who are reporting distressing visual hallucinations in the past month.
Key inclusion criteria (3 listed)
- Meet entry criteria for Early Intervention in Psychosis (EIP) services
- Distressing visual hallucinations
- Age 18-38 years (the usual upper range of the EIP services)
Key exclusion criteria (5 listed)
- Organic brain disease including dementia, epileptic psychosis, head injury (may be alternative cause of symptoms, or impair cognitive function and ability to do CBT)
- Primary diagnosis of drug or alcohol misuse (as above)
- Impaired intellect severe enough to interfere with ratings (as above)
- In-patient/acute psychiatric care needed at baseline assessment (patients must be well enough to engage in out-patient CBT)
- Previous CBT for psychosis (those previously exposed to the CBT model may be more likely to respond to CBT)
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 |
|---|---|---|
| CBT for Distressing visual hallucinationsAlso: Cognitive Behavioural therapy for visual hallucinationsEight to ten sessions of manualised CBT for distressing visual hallucinations based on existing treatment manuals (ie. Kingdon \& Turkington, 2004, Morrison et al., 2005), delivered over 8 to 12 weeks by CBT therapists. Subjects will continue to receive treatment as usual throughout the therapy period and will receive appropriate prescription of medication if requested or clinically indicated. | Behavioural | – |
Primary outcome
Change from baseline in distress of visual hallucinations as assessed by the Psychotic symptoms rating scale for hallucinations (PSYRATS).
Time frame: change pre to post intervention which will be on average 3 months
The PSYRATS measures distress, conviction and preoccupation and impact of life of symptoms such as voices or delusions. It has been adapted to be relevant to visual hallucinations.
2 secondary outcomes
Change from baseline on measure of depression (Beck Depression Inventory)
Time frame: Baseline and at three months
Change from baseline on measure of symptoms of psychosis as measured by he Schizophrenia Change Scale (SCS). The SCS is a subscale of the Comprehensive Psychopathological Rating Scale (CPRS), (Montgomery, Taylor, & Montgomery, 1978)
Time frame: baseline and at three 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 31 Oct 2017.
- Individual participant dataSharing planned: Yes. The findings are shared with the individual participants and an anonymised version of the material is to be submitted for publication. The participants have consented to the sharing of anonymised material in this format.
Related trials for Visual Hallucinations
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RecruitingObservational study
Visual Hallucinations in Lewy Body Diseases
Lewy Body Disease, Lewy Body Dementia
Enrolling by invitationObservational study
Charles Bonnet Syndrome in Low Vision Patients
Charles Bonnet Syndrome
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.
Robert Dudley, Ph.D principal investigator
Newcastle University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Visual Hallucinations and Psychotic Disorders, run by Newcastle University 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 3 inclusion and 5 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 31 Oct 2017. 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?
Change from baseline in distress of visual hallucinations as assessed by the Psychotic symptoms rating scale for hallucinations (PSYRATS). (time frame: change pre to post intervention which will be on average 3 months). 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 31 Oct 2017.