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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03048695
• Other study ID #: 150601
• Status: Completed
• Phase: N/A
• Start date: May 18, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2021
• Source: Sykehuset Innlandet HF
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 67 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neurocognitive Disorders
• Schizophrenia

Intervention

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

Locations

Country	Name	City	State
Norway	Sykehuset Innlandet Reinsvoll	Reinsvoll

Sponsors (2)

Lead Sponsor	Collaborator
Sykehuset Innlandet HF	University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Behavior Rating Inventory for Executive Functions	Assessing change	Baseline, immediately post-intervention and 6 months follow-up
Primary	Conners Continuous Performance Test III	Assessing change	Baseline, immediately post-intervention and 6 months follow-up
Primary	Positive and Negative Syndrome Scale	Assessing change	Baseline, immediately post-intervention and 6 months follow-up
Secondary	Global Assessment of Functioning-Split Version	Assessing change	Baseline, immediately post-intervention and 6 months follow-up
Secondary	The Hotel Task	Assessing change	Baseline, immediately post-intervention and 6 months follow-up
Secondary	Delis Kaplan Executive Function System (D-KEFS) subtests	Assessing change	Baseline, immediately post-intervention and 6 months follow-up
Secondary	Digit span and Letter-number sequencing	Assessing change	Baseline, immediately post-intervention and 6 months follow-up
Secondary	Iowa Gambling Task	Assessing change	Baseline, immediately post-intervention and 6 months follow-up
Secondary	Dysexecutive Questionnaire (self-and informant)	Assessing change	Baseline, immediately post-intervention and 6 months follow-up
Secondary	Cognitive Failures Questionnaire	Assessing change	Baseline, immediately post-intervention and 6 months follow-up
Secondary	Goal Attainment Scaling	Assessing change	Baseline, immediately post-intervention and 6 months follow-up
Secondary	Everyday Functioning from NORMENT Long time follow up questionnaires	Assessing change	Baseline, immediately post-intervention and 6 months follow-up
Secondary	General Perceived Self-Efficacy Scale	Assessing change	Baseline, immediately post-intervention and 6 months follow-up
Secondary	Social Functioning Scale	Assessing change	Baseline, immediately post-intervention and 6 months follow-up
Secondary	The Perceived Quality of Life Scale	Assessing change	Baseline, immediately post-intervention and 6 months follow-up
Secondary	Rosenberg self-esteem scale	Assessing change	Baseline, immediately post-intervention and 6 months follow-up
Secondary	Hopkins Symptom Checklist 10	Assessing change	Baseline, immediately post-intervention and 6 months follow-up