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Contrasting Group Therapy Methods for Psychosis (MCT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of British Columbia
Sponsor:
Collaborators:
Vancouver Coastal Health Research Institute
Vancouver General Hospital
Vancouver Coastal Health
VGH and UBC Hospital Foundation
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01764568
First received: November 28, 2012
Last updated: July 2, 2014
Last verified: July 2014
  Purpose

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:

  1. MCT will produce greater change in delusions (severity and conviction) than CR and TAU.
  2. CR and MCT will produce greater change in social/everyday functioning than TAU.
  3. CR will produce greater improvement in basic attention and memory measures relative to MCT and TAU.
  4. MCT will produce greater reduction on tasks measuring targeted reasoning biases relative to CR and TAU.
  5. CR will increase efficiency of functional networks on a working memory task relative to MCT and TAU.
  6. MCT will lead to a greater decrease in the neural response to evidence matches relative to CR and TAU.

Condition Intervention
Psychosis
Schizophrenia
Schizoaffective Disorder
Schizophreniform Disorder
Behavioral: Metacognitive Training (MCT)
Behavioral: Cognitive Remediation (CR)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Functional Brain Networks Underlying Non-pharmaceutical Interventions for Psychosis.

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Delusion Severity [ Time Frame: 8-12 weeks (post-treatment) relative to baseline (pre-treatment) ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Symptom Ratings [ Time Frame: 4 weeks (midpoint of therapy) relative to baseline (pre-treatment) ] [ Designated as safety issue: No ]
    General psychopathology will be assessed using the Scale for the Assessment of Negative Symptoms (SANS; Andreasen, 1984) and the Scale for the Assessment of Positive Symptoms (SAPS; Andreasen, 1984). Patient depressive symptoms will be measured using the Beck Depression Inventory, Second Edition (BDI-II; Beck, 1996). Patient perception of their quality of life will be measured using the World Health Organisation Quality of Life Scale (WHOQoL). Patient perception of stigma and its impact on their quality of life will be measured using the Internalized Stigma of Mental Illness scale (Ritsher et al, 2003). All symptom ratings will be administered by trained raters blinded to the treatment allocation of subjects.

  • Symptom Ratings [ Time Frame: 8-12 weeks (post-treatment) relative to baseline (pre-treatment) ] [ Designated as safety issue: No ]
    General psychopathology will be assessed using the Scale for the Assessment of Negative Symptoms (SANS; Andreasen, 1984) and the Scale for the Assessment of Positive Symptoms (SAPS; Andreasen, 1984). Patient depressive symptoms will be measured using the Beck Depression Inventory, Second Edition (BDI-II, Beck 1996). Patient perception of their quality of life will be measured using the World Health Organization Quality of Life scale (WHOQoL). Patient perception of stigma and its impact on their quality of life will be measured using the Internalized Stigma of Mental Illness scale (Ritsher et al, 2003). All symptom rating scales will be administered by trained raters blinded to the treatment allocation of subjects.

  • Cognitive Function [ Time Frame: Pre-treatment (prior to commencement of therapy) ] [ Designated as safety issue: No ]
    The Test of Premorbid Function (ToPF) is a word-reading task that will be used to estimate the premorbid intelligence (IQ) of the individual (Wechsler, 2011). The Wechsler Abbreviated Scale of Intelligence, Second Edition (WASI-II; Wechsler, 2011) will provide a measure of current cognitive function (or intelligence). The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS; Randolph, 1998) will be used to review neurocognitive function of the individual, including attention, processing speed, working memory, verbal and visual memory. Trailmaking Test will provide measures of basic attention, speed of processing, mental flexibility, and executive functioning. The Controlled Oral Word Association test (COWAT) is a verbal fluency task that measures executive functioning. The Letter Number Sequencing test measures working memory, with ability to recall and organize a sequence of letters and numbers (Wechsler, 2011).

  • Cognitive Function [ Time Frame: 4 weeks (midpoint of therapy) relative to baseline (pre-treatment) ] [ Designated as safety issue: No ]
    The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS; Randolph, 1998) will be used to review neurocognitive function of the individual, including attention, processing speed, working memory, verbal and visual memory. Trailmaking Test will provide measures of basic attention, speed of processing, mental flexibility, and executive functioning. The Controlled Oral Word Association test (COWAT) is a verbal fluency task that measures executive functioning.

  • Cognitive Function [ Time Frame: 8-12 weeks (post-treatment) relative to baseline (pre-treatment) ] [ Designated as safety issue: No ]
    The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS; Randolph, 1998) will be used to review neurocognitive function of the individual, including attention, processing speed, working memory, verbal and visual memory. Trailmaking Test will provide measures of basic attention, speed of processing, mental flexibility, and executive functioning. The Controlled Oral Word Association test (COWAT) is a verbal fluency task that measures executive functioning. The Letter Number Sequencing test is a measure of working memory, with the ability to recall and organize a sequence of letters and numbers (Wechsler, 2011).

  • Cognitive Bias [ Time Frame: 4 weeks (midpoint of therapy) relative to baseline (pre-treatment) ] [ Designated as safety issue: No ]
    Two cognitive biases commonly seen in schizophrenia will be evaluated using the "jumping to conclusions (JTC)" tasks and the "bias against disconfirmatory evidence (BADE)" tasks. These tasks were developed, in part, by the principal investigator and have been described in previous research (Lecomte & Woodward 2005; Woodward 2006a; Woodward 2006b; Woodward 2007; Moritz & Woodward 2005; Woodward 2009).

  • Cognitive Bias [ Time Frame: 8-12 weeks (post-treatment) relative to baseline (pre-treatment) ] [ Designated as safety issue: No ]
    Two cognitive biases commonly seen in schizophrenia will be evaluated using the "jumping to conclusions (JTC) scale" and the "bias against disconfirmatory evidence (BADE)" tasks. These tasks were developed, in part, by the principal investigator and have been described in previous research (Lecomte & Woodward 2005; Woodward 2006a; Woodward 2006b; Woodward 2007; Moritz & Woodward 2005; Woodward 2009).

  • Insight [ Time Frame: 4 weeks (midpoint of therapy) relative to baseline (pre-treatment) ] [ Designated as safety issue: No ]
    The Beck Cognitive Insight Scale (BCIS; Beck, Baruch, Balter, Steer, & Warman 2004) will be administered to evaluate patients' degree of insight into cognitive biases and limitations.

  • Insight [ Time Frame: 8-12 weeks (post-treatment) relative to baseline (pre-treatment) ] [ Designated as safety issue: No ]
    The Beck Cognitive Insight Scale (BCIS; Beck, Baruch, Balter, Steer, & Warman 2004) will be administered to evaluate patients' degree of insight into cognitive biases and limitations.

  • Social cognition [ Time Frame: 4 weeks (midpoint of therapy) relative to baseline (pre-treatment) ] [ Designated as safety issue: No ]
    Social cognition will be assessed using the Ambiguous Intentions Hostility Questionnaire (AHIQ; Combs et al, 2007), which measures hostile social cognitive biases in those with paranoia.

  • Social Cognition [ Time Frame: 8-12 weeks (post-treatment) relative to baseline (pre-treatment) ] [ Designated as safety issue: No ]
    Social cognition will be assessed using the Ambiguous Intentions Hostility Questionnaire (AHIQ; Combs et al, 2007), which measures hostile social cognitive biases in those with paranoia. Social perception and cognition will be assessed using The Awareness of Social Inference Test (TASIT; McDonald et al, 2003), to determine if either intervention may improve everyday communication skills that rely upon understanding of emotional expression and social context to convey meaning.

  • Psychosocial/Everyday Functioning [ Time Frame: 4 weeks (midpoint of therapy) relative to baseline (pre-treatment) ] [ Designated as safety issue: No ]
    Subjects social functioning in daily interactions will be assessed using the Social Functioning Scale (SFS; Birchwood et al., 1990) and their overall daily function will be assessed using the Functioning Assessment Short Test (FAST, Rosa et al, 2007).

  • Psychosocial/Everyday Functioning [ Time Frame: 8-12 weeks (post-treatment) relative to baseline (pre-treatment) ] [ Designated as safety issue: No ]
    Subjects social functioning in daily interactions will be assessed using the Social Functioning Scale (SFS; Birchwood et al., 1990) and their overall daily function will be assessed using the Functioning Assessment Short Test (FAST, Rosa et al, 2007).

  • Feasibility and acceptability [ Time Frame: 8-12 weeks (post-treatment) ] [ Designated as safety issue: No ]
    After the final session in active treatment conditions, patients will be asked to complete a questionnaire comprising 10 questions on acceptance and subjective efficacy (Moritz & Woodward, 2007a). Data accumulated therein will be used together with frequency of unattended sessions to establish acceptability and feasibility of the various treatment conditions.


Estimated Enrollment: 150
Study Start Date: January 2013
Estimated Study Completion Date: September 2019
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Metacognitive Training (MCT)
The metacognitive group training program that will form the basis of the 16 session MCT intervention has been described in previous research (Moritz & Woodward 2007a; Moritz & Woodward 2007b; Moritz 2011) and can be obtained online at no cost (www.uke.de/mkt). This experimental intervention will consist of two 8‐module cycles occurring twice a week for 8 weeks, for a total of 16 sessions. Each module will include a 45 to 60 minute instructor-led group session using PowerPoint slides and homework assignments to facilitate learning. Groups will consist of 4-10 subjects. Subjects will be able to attend the alternate (Cognitive Remediation) group after completion of the MCT group if they wish.
Behavioral: Metacognitive Training (MCT)
The metacognitive group training program that will form the basis of the 16 session MCT intervention has been described in previous research (Moritz & Woodward 2007a; Moritz & Woodward 2007b; Moritz 2011) and can be obtained online at no cost (www.uke.de/mkt). This experimental intervention will consist of two 8‐module cycles occurring twice a week for 8 weeks, for a total of 16 sessions. Each module will include a 45 to 60 minute instructor-led group session using PowerPoint slides and homework assignments to facilitate learning. Groups will consist of 4-10 subjects. Subjects will be able to attend the alternate (Cognitive Remediation) group after completion of the MCT group if they wish.
Experimental: Cognitive remediation (CR)
The CR group will use a computerized cognitive remediation program that has been used with schizophrenia patients, Scientific Brain Training Pro (SBT Pro; Vianin et al, 2010). Modules will focus specifically on attention, processing, speed, working memory, verbal memory, as well as planning and reasoning. Treatment administration will be individual in that each participant will work through exercises on personal tablet computers and personalized level of difficulty. Each session will incorporate psycho-educational group discussion regarding how strategies learned through these tasks can be applied to everyday function. the CR treatment will take place twice per week for 8 weeks, for a total of 16 sessions. Groups will consist of 4-10 subjects. Subjects will be able to attend MCT after completion of CR if they wish.
Behavioral: Cognitive Remediation (CR)
The CR group will use a computerized cognitive remediation program that has been used with schizophrenia patients, Scientific Brain Training Pro (SBT Pro; Vianin et al, 2010). Modules will focus specifically on attention, processing, speed, working memory, verbal memory, as well as planning and reasoning. Treatment administration will be individual in that each participant will work through exercises on personal tablet computers and personalized level of difficulty. Each session will incorporate psycho-educational group discussion regarding how strategies learned through these tasks can be applied to everyday function. the CR treatment will take place twice per week for 8 weeks, for a total of 16 sessions. Groups will consist of 4-10 subjects. Subjects will be able to attend MCT after completion of CR if they wish.
No Intervention: Treatment As Usual
This group will be identified as the "wait list" group and subjects will be assigned to an 8 week treatment as usual (TAU) while still taking part in baseline, midpoint, and end-point assessments. Subjects will be offered the opportunity to enter either the MCT or CR group after 8 weeks on the wait list and completion of the final assessment. Subjects will be able to attend both groups, one after the other, if they wish.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   19 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Between the ages of 19 to 55 years
  2. Diagnosis of schizophrenia, schizoaffective disorder or schizophreniform disorder.

Exclusion Criteria for Intervention Groups:

  1. 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.
  2. A history of severe neurological disorder and those with severe manifestations of hostility, megalomania, formal thought disorder and suspiciousness.
  3. Subjects who are obtaining ongoing electroconvulsive therapy (ECT)
  4. 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):

  1. History of brain damage or other medical problems that may affect comprehension (e.g., seizure disorders, stroke, aneurysm, brain tumor, etc.)
  2. Psychosis that is a direct consequence of substance abuse.
  3. Currently suffer from severe substance dependence.
  4. Surgery within the last 6 weeks.
  5. Surgery to the brain, heart or eyes.
  6. Metal implants
  7. Metal fragments in or near your eyes.
  8. Pregnant.
  9. Recent serious concussion, or loss of consciousness of more than 10 minutes.
  10. Colour blind

In addition to the group exclusion criteria, the exclusion criteria for Neuroimaging EEG:

  1. History of brain damage or other medical problems that may affect comprehension (e.g., seizure disorders, stroke, aneurysm, brain tumor, etc.)
  2. Recent serious concussion, or loss of consciousness of more than 10 minutes
  3. Currently suffer from severe substance dependence.
  4. Colour blind
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01764568

Contacts
Contact: Emma M Davis, MSc 604-822-7312 emma.davis@ubc.ca
Contact: Todd Woodward, PhD 604-875-2000 ext 4724 todd.woodward@ubc.ca

Locations
Canada, British Columbia
UBC Hospital - Detwiller Pavilion Recruiting
Vancouver, British Columbia, Canada, V6T 2A1
Contact: Mahesh Menon, PhD    604-822-7312    Mahesh.menon@ubc.ca   
Principal Investigator: Todd Woodward, PhD         
Sub-Investigator: Mahesh Menon, PhD         
Sub-Investigator: Devon Andersen, M.A         
Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Chris Flynn       Chris.Flynn@vch.ca   
Sponsors and Collaborators
University of British Columbia
Vancouver Coastal Health Research Institute
Vancouver General Hospital
Vancouver Coastal Health
VGH and UBC Hospital Foundation
Investigators
Principal Investigator: Todd Woodward, PhD University of British Columbia
  More Information

Publications:
Canadian Psychiatric Association (2005). Clinical practice guidelines. Treatment of schizophrenia. Canadian journal of psychiatry, 50, 7S-57S.
Lecomte, T., Woodward, T. S., & Leclerc, C. (2005). Changes in the jumping-to-conclusions bias are associated with changes in delusions: A longitudinal study involving cognitive behavioural therapy [abstract]. Schizophrenia Research, 31, 365.
McGurk, S. R., Twamley, E. W., Sitzer, D. I., McHuge, G. J., Mueser, K. T. (2007). A meta-analysis of cognitive remediation in schizophrenia. American Journal of Psychiatry, 164(12). 1791-802.

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01764568     History of Changes
Other Study ID Numbers: H12-01968, F11-02233
Study First Received: November 28, 2012
Last Updated: July 2, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Metacognitive training
Cognitive behavioral therapy
Clinical trial
Group intervention
Group therapy
Schizophrenia
Psychosis
Cognitive remediation

Additional relevant MeSH terms:
Disease
Mental Disorders
Psychotic Disorders
Schizophrenia
Pathologic Processes
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on November 20, 2014