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

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

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?

Study Overview

• Status: Completed
• Conditions: Neurocognitive Disorders; Schizophrenia
• Intervention / Treatment: Behavioral: GMT

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Reinsvoll, Norway, 2840
    • Sykehuset Innlandet Reinsvoll

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 67 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sykehuset Innlandet HF
• Collaborators: University of Oslo
• Investigators: Principal Investigator: Merete G Øie, Phd, Sykehuset Innlandet HF

Publications and helpful links

General Publications

• Haugen I, Stubberud J, Haug E, McGurk SR, Hovik KT, Ueland T, Oie MG. A randomized controlled trial of Goal Management Training for executive functioning in schizophrenia spectrum disorders or psychosis risk syndromes. BMC Psychiatry. 2022 Aug 28;22(1):575. doi: 10.1186/s12888-022-04197-3.

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2017
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: January 16, 2017
• First Submitted That Met QC Criteria: February 6, 2017
• First Posted (Estimate): February 9, 2017

Study Record Updates

• Last Update Posted (Actual): February 10, 2021
• Last Update Submitted That Met QC Criteria: February 9, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Neurocognitive Disorders
• Other Study ID Numbers: 150601

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No