Cognitive Therapy for Distressing Visual Hallucinations: A Pilot Study

NCT02782507 | Completed

• 1 other identifier: FSF 2010 / 11
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Visual Hallucinations; Psychotic Disorders

Keywords

pilot study; CBT trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change from baseline on measure of depression (Beck Depression Inventory)

  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)

  baseline and at three months

Interventions

CBT for Distressing visual hallucinations BEHAVIORAL

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.

Also known as: Cognitive Behavioural therapy for visual hallucinations

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Newcastle University: lead
• Northumberland, Tyne and Wear NHS Foundation Trust: collaborator

Study Sites (1)

Early Intervention in Psychosis service

Sunderland, Tyne and Wear, SR5 1NB, United Kingdom

Location

MeSH Terms

Conditions

Hallucinations; Psychotic Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Robert Dudley, Ph.D

  Newcastle University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2013
• First Posted: May 25, 2016
• Study Start: January 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: October 31, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)