Contrasting Group Therapy Methods for Psychosis

NCT01764568 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2024-04-11

No results posted yet for this study

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:

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.

Conditions

Interventions

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.

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 focus on attention, working memory, verbal memory, and planning and reasoning. Each session will incorporate psycho-educational group discussion of strategies, and individual work through exercises on personal tablet computers and personalized level of difficulty. 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.

Sponsors & Collaborators

  • Vancouver Coastal Health Research Institute

    collaborator OTHER
  • Vancouver General Hospital

    collaborator OTHER
  • Vancouver Coastal Health

    collaborator OTHER_GOV
  • VGH and UBC Hospital Foundation

    collaborator OTHER
  • University of British Columbia

    lead OTHER

Principal Investigators

  • Todd Woodward, PhD · University of British Columbia

  • Mahesh Menon, PhD, RPsych · University of British Columbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
19 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2022-06-30
Completion
2022-06-30

Countries

  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01764568 on ClinicalTrials.gov