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

Overview

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?

Full Title of Study: “Cognitive Remediation of Executive Dysfunction – Goal Management Training for Patients With Schizophrenia or High Risk for Schizophrenia”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: December 31, 2021

Interventions

  • Behavioral: GMT
    • Metacognitive strategy training where the primary objective is to stop ongoing behavior to define goal hierarchies and monitor performance

Arms, Groups and Cohorts

  • Experimental: Goal Management Training
    • Cognitive rehabilitation
  • No Intervention: Waiting list

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 16 Years

Maximum Age: 67 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sykehuset Innlandet HF
  • Collaborator
    • University of Oslo
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Merete G Øie, Phd, Principal Investigator, Sykehuset Innlandet HF

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