Clinical trial NCT03048695: Goal Management Training for Patients With Schizophrenia or High Risk for Schizophrenia
Official title: Cognitive Remediation of Executive Dysfunction - Goal Management Training for Patients With Schizophrenia or High Risk for Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Neurocognitive Disorders
Lead sponsor: Sykehuset Innlandet HF
Sponsor class: OTHER
Collaborators: name: University of Oslo
First posted: 2017-02-09
Enrollment: 83
Sex: ALL
Minimum age (years): 16
Maximum age (years): 67
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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?


Eligibility criteria: 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.

Primary outcomes:
measure: Behavior Rating Inventory for Executive Functions
timeFrame: Baseline, immediately post-intervention and 6 months follow-up
measure: Conners Continuous Performance Test III
timeFrame: Baseline, immediately post-intervention and 6 months follow-up
measure: Positive and Negative Syndrome Scale
timeFrame: Baseline, immediately post-intervention and 6 months follow-up
Secondary outcomes:
measure: Global Assessment of Functioning-Split Version
timeFrame: Baseline, immediately post-intervention and 6 months follow-up
measure: The Hotel Task
timeFrame: Baseline, immediately post-intervention and 6 months follow-up
measure: Delis Kaplan Executive Function System (D-KEFS) subtests
timeFrame: Baseline, immediately post-intervention and 6 months follow-up
measure: Digit span and Letter-number sequencing
timeFrame: Baseline, immediately post-intervention and 6 months follow-up
measure: Iowa Gambling Task
timeFrame: Baseline, immediately post-intervention and 6 months follow-up
measure: Dysexecutive Questionnaire (self-and informant)
timeFrame: Baseline, immediately post-intervention and 6 months follow-up
measure: Cognitive Failures Questionnaire
timeFrame: Baseline, immediately post-intervention and 6 months follow-up
measure: Goal Attainment Scaling
timeFrame: Baseline, immediately post-intervention and 6 months follow-up
measure: Everyday Functioning from NORMENT Long time follow up questionnaires
timeFrame: Baseline, immediately post-intervention and 6 months follow-up
measure: General Perceived Self-Efficacy Scale
timeFrame: Baseline, immediately post-intervention and 6 months follow-up
measure: Social Functioning Scale
timeFrame: Baseline, immediately post-intervention and 6 months follow-up
measure: The Perceived Quality of Life Scale
timeFrame: Baseline, immediately post-intervention and 6 months follow-up
measure: Rosenberg self-esteem scale
timeFrame: Baseline, immediately post-intervention and 6 months follow-up
measure: Hopkins Symptom Checklist 10
timeFrame: Baseline, immediately post-intervention and 6 months follow-up
Other outcomes:
Locations:
city: Reinsvoll
country: Norway
facility: Sykehuset Innlandet Reinsvoll
Study officials:
affiliation: Sykehuset Innlandet HF
name: Merete G Øie, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.