Cognitive Therapy for Distressing Visual Hallucinations: A Pilot Study

Study Overview
=================
Brief 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). 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.

Official Title
-----------------
Cognitive Therapy for Distressing Visual Hallucinations: A Pilot Study

Conditions
-----------------
Visual Hallucinations, Psychotic Disorders

Intervention / Treatment
-----------------
* Behavioral: CBT for Distressing visual hallucinations


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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) Exclusion Criteria: 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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 38 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: CBT for Distressing 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 the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | change pre to post intervention which will be on average 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | baseline and at three months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pilot study, CBT trial