Functional Brain Networks Underlying Non-pharmaceutical Interventions for Psychosis.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 129
- Locations
- 2
- Primary Endpoint
- Delusion Severity
Study Overview
Brief Summary
Current Canadian Clinical Practice guidelines emphasize the need for effective psychosocial adjuncts to pharmacotherapy for schizophrenia (Canadian Psychiatric Association 2005). This randomized control trial seeks to contribute to the body of evidence supporting psychosocial treatments by assessing the effectiveness of metacognitive training (MCT) and cognitive remediation (CR) at treating the persistent positive and cognitive symptoms of schizophrenia. MCT is a therapy designed to improve patient awareness and insight into the cognitive biases that are frequently seen in schizophrenia; it has been associated with decreased psychopathology (specifically decreased positive symptoms) and improved psychosocial function. CR is a therapy designed to improve performance in a variety of neurocognitive functions such as attention, memory, and executive functioning; it has been associated with improved cognitive and psychosocial functioning. Both MCT and CR will be compared to treatment as usual (TAU) as done previously (Kumar er al., 2010; Moritz et al., 2011).
Hypotheses:
- MCT will produce greater change in delusions (severity and conviction) than CR and TAU.
- CR and MCT will produce greater change in social/everyday functioning than TAU.
- CR will produce greater improvement in basic attention and memory measures relative to MCT and TAU.
- MCT will produce greater reduction on tasks measuring targeted reasoning biases relative to CR and TAU.
- CR will increase efficiency of functional networks on a working memory task relative to MCT and TAU.
- MCT will lead to a greater decrease in the neural response to evidence matches relative to CR and TAU.
Detailed Description
Objectives:
The objectives of this research project is to assess the relative effectiveness of MCT and CR at treating the persistent positive symptoms of schizophrenia in a stable patient population. Specifically, we will use verified measures to examine the impact of these interventions on delusion conviction and severity, as well as on other features of interest, including insight and specific cognitive biases. We will use functional neuroimaging, both electroencephalography (EEG) and functional Magnetic Resonance Imaging (fMRI), to measure the changes in the neural responses while subjects are performing various cognitive tasks. It is expected that improvements in cognitive performance and function seen with MCT and CR correlate with select improvements in efficiency of particular brain networks. We anticipate a double dissociation, in that subjects with decreased positive symptoms following MCT may present with different patterns of activation than those with improved neurocognitive function following CR.
Procedures:
Recruitment will be done through inpatient and outpatient departments in Vancouver, British Columbia, Canada. Diagnosis of schizophrenia spectrum disorder will be confirmed using the MINI (Sheehan, 1998). Both inpatients and outpatients will be recruited; patients must be identified as suitable, as determined by their treating psychiatric team. This will suffice to obtain 50 subjects per condition over 5 years. Note that our intended sample size was originally 75 per group, which would allow for attrition and still give us an estimated 50 subjects with completed and valid behavioural and neuroimaging data.
Participants who complete the screening and baseline (pre-treatment) assessments will be randomly assigned to one of 3 conditions: 1) MCT, 2) CR, or 3) TAU. Randomization of subjects will occur as they complete their baseline assessments, and entry into the groups will involve a rolling intake model. Interventions will be administered twice weekly for 8 weeks. The groups will be run by Clinical Psychologists and PhD level psychology students. Allied health professionals, such as Occupational Therapists or Social Workers, may co-facilitate groups.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 19 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Between the ages of 19 to 60 years
- •Diagnosis of schizophrenia, schizoaffective disorder or schizophreniform disorder.
- •Diagnosis of mood disorder with current psychosis.
Exclusion Criteria
- •An inability to read and write in English. Participants must be have used English on a daily basis for at least 5 years, and must be able to understand the consent form and give written consent.
- •A history of severe neurological disorder and those with severe manifestations of hostility, megalomania, formal thought disorder and suspiciousness.
- •Subjects who are obtaining ongoing electroconvulsive therapy (ECT)
- •Subjects who are consistently disrupting the rest of the group might be asked to leave, this will be at the discretion of the group instructor.
- •In addition to the group exclusion criteria, the exclusion criteria for Neuroimaging (fMRI):
- •History of brain damage or other medical problems that may affect comprehension (e.g., seizure disorders, stroke, aneurysm, brain tumor, etc.)
- •Psychosis that is a direct consequence of substance abuse.
- •Currently suffer from severe substance dependence.
- •Surgery within the last 6 weeks.
- •Surgery to the brain, heart or eyes.
- •Metal implants
- •Metal fragments in or near your eyes.
- •Recent serious concussion, or loss of consciousness of more than 10 minutes.
- •Colour blind
- •In addition to the group exclusion criteria, the exclusion criteria for Neuroimaging EEG:
- •History of brain damage or other medical problems that may affect comprehension (e.g., seizure disorders, stroke, aneurysm, brain tumor, etc.)
- •Recent serious concussion, or loss of consciousness of more than 10 minutes
- •Currently suffer from severe substance dependence.
- •Colour blind
Outcomes
Primary Outcomes
Delusion Severity
Time Frame: 8-12 weeks (post-treatment) relative to baseline (pre-treatment)
Delusion severity will be measured using the Delusions Scale of the Psychotic Symptom Rating Scales (PSYRATS; Haddock, McCarron, Tarrier, \& Faragher, 1999). The PSYRATS Delusion Scale measures more specific aspects of delusions such as conviction and impact on thinking.
Secondary Outcomes
- Cognitive Bias(8-12 weeks (post-treatment) relative to baseline (pre-treatment))
- Symptom Ratings(8-12 weeks (post-treatment) relative to baseline (pre-treatment))
- Cognitive Function(8-12 weeks (post-treatment) relative to baseline (pre-treatment))
- Psychosocial/Everyday Functioning(8-12 weeks (post-treatment) relative to baseline (pre-treatment))
- Feasibility and acceptability(8-12 weeks (post-treatment))
- Insight(8-12 weeks (post-treatment) relative to baseline (pre-treatment))
Investigators
Todd Woodward
Professor
University of British Columbia