Goal Management Training for Patients With Schizophrenia or High Risk for Schizophrenia

Study Overview
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Brief Summary
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About 85% of patients with schizophrenia have cognitive impairments, executive functions being particularly affected. Executive dysfunction, and cognitive deficits in general, are important predictors of functional outcomes, including social problem solving, activities of daily living, life satisfaction, and the ability to return to work or school.The main objective of the current study is to examine the efficacy of group-based Goal Management Training (GMT) for patients with broad schizophrenia spectrum disorders or high risk individuals with executive deficits. The short term goals are to investigate whether GMT can improve participants' ability to organize and achieve goals in everyday life in addition to improving aspects of emotional health. A long-term goal would be to establish an evidence base for nonpharmacological interventions for patients with broad schizophrenia spectrum disorders or high risk for schizophrenia. Main research questions: (1) Does a RCT with GMT delivered to patients with broad schizophrenia spectrum disorders or high risk for schizophrenia result in improved executive functioning, measured by self-reported and/or objective measures of executive functions? (2) Does GMT result in improved goal attainment in everyday life, social- and real world functioning? (3) Does GMT have a positive impact on the patients' emotional health? (4) Are there specific characteristics in patients with broad schizophrenia spectrum disorders or high risk for schizophrenia that are associated with better treatment benefit from GMT?

Official Title
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Cognitive Remediation of Executive Dysfunction - Goal Management Training for Patients With Schizophrenia or High Risk for Schizophrenia

Conditions
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Schizophrenia, Neurocognitive Disorders

Intervention / Treatment
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* Behavioral: GMT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Being consecutively referred to treatment for a DSM-IV diagnosis of broad schizophrenia spectrum psychosis (schizophrenia, schizophreniform disorder and schizoaffective disorder) or high risk for psychosis or being treated for psychotic disorder for less than 5 years. Reporting executive problems through (a) structured interview, or (b) self-report, i.e. BRIEF scale T-score < 55. Exclusion Criteria: Reported ongoing alcohol or substance abuse. Premorbid neurological disease or insult and/or comorbid neurological disease. ° Severe cognitive problems interfering with the capacity to participate. IQ below 70.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 67 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Goal Management Training<br>Cognitive rehabilitation | Behavioral: GMT<br>* Metacognitive strategy training where the primary objective is to stop ongoing behavior to define goal hierarchies and monitor performance<br>|
| No Intervention: Waiting list<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behavior Rating Inventory for Executive Functions | Assessing change | Baseline, immediately post-intervention and 6 months follow-up | 
| Conners Continuous Performance Test III | Assessing change | Baseline, immediately post-intervention and 6 months follow-up | 
| Positive and Negative Syndrome Scale | Assessing change | Baseline, immediately post-intervention and 6 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Assessment of Functioning-Split Version | Assessing change | Baseline, immediately post-intervention and 6 months follow-up | 
| The Hotel Task | Assessing change | Baseline, immediately post-intervention and 6 months follow-up | 
| Delis Kaplan Executive Function System (D-KEFS) subtests | Assessing change | Baseline, immediately post-intervention and 6 months follow-up | 
| Digit span and Letter-number sequencing | Assessing change | Baseline, immediately post-intervention and 6 months follow-up | 
| Iowa Gambling Task | Assessing change | Baseline, immediately post-intervention and 6 months follow-up | 
| Dysexecutive Questionnaire (self-and informant) | Assessing change | Baseline, immediately post-intervention and 6 months follow-up | 
| Cognitive Failures Questionnaire | Assessing change | Baseline, immediately post-intervention and 6 months follow-up | 
| Goal Attainment Scaling | Assessing change | Baseline, immediately post-intervention and 6 months follow-up | 
| Everyday Functioning from NORMENT Long time follow up questionnaires | Assessing change | Baseline, immediately post-intervention and 6 months follow-up | 
| General Perceived Self-Efficacy Scale | Assessing change | Baseline, immediately post-intervention and 6 months follow-up | 
| Social Functioning Scale | Assessing change | Baseline, immediately post-intervention and 6 months follow-up | 
| The Perceived Quality of Life Scale | Assessing change | Baseline, immediately post-intervention and 6 months follow-up | 
| Rosenberg self-esteem scale | Assessing change | Baseline, immediately post-intervention and 6 months follow-up | 
| Hopkins Symptom Checklist 10 | Assessing change | Baseline, immediately post-intervention and 6 months follow-up |