Cognitive Therapy for Distressing Visual Hallucinations: A Pilot 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.

Study Overview

• Status: Completed
• Conditions: Psychotic Disorders; Visual Hallucinations
• Intervention / Treatment: Behavioral: CBT for Distressing 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 Type: Observational
• Enrollment (Actual): 7

Contacts and Locations

Study Locations

• United Kingdom
  • Tyne and Wear
    • Sunderland, Tyne and Wear, United Kingdom, SR5 1NB
      • Early Intervention in Psychosis service

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 36 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

People in Early Intervention in Psychosis services who are reporting distressing visual hallucinations in the past month.

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

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

Collaborators and Investigators

• Sponsor: Newcastle University
• Collaborators: Northumberland, Tyne and Wear NHS Foundation Trust
• Investigators: Principal Investigator: Robert Dudley, Ph.D, Newcastle University

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: June 19, 2013
• First Submitted That Met QC Criteria: May 24, 2016
• First Posted (Estimate): May 25, 2016

Study Record Updates

• Last Update Posted (Actual): October 31, 2017
• Last Update Submitted That Met QC Criteria: October 27, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: pilot study; CBT trial
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Schizophrenia Spectrum and Other Psychotic Disorders; Perceptual Disorders; Psychotic Disorders; Mental Disorders; Hallucinations
• Other Study ID Numbers: FSF 2010 / 11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: 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.