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

NCT03048695 | Completed

• 1 other identifier: 150601
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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?

Conditions

Schizophrenia; Neurocognitive Disorders

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (14)

• Global Assessment of Functioning-Split Version

  Baseline, immediately post-intervention and 6 months follow-up

• The Hotel Task

  Baseline, immediately post-intervention and 6 months follow-up

• Delis Kaplan Executive Function System (D-KEFS) subtests

  Baseline, immediately post-intervention and 6 months follow-up

• Digit span and Letter-number sequencing

  Baseline, immediately post-intervention and 6 months follow-up

• Iowa Gambling Task

  Baseline, immediately post-intervention and 6 months follow-up

Study Arms (2)

Goal Management Training

EXPERIMENTAL

Cognitive rehabilitation

Behavioral: GMT

Waiting list

NO INTERVENTION

Interventions

GMT BEHAVIORAL

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

Goal Management Training

Eligibility Criteria

• Age: 16 Years - 67 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sykehuset Innlandet HF: lead
• University of Oslo: collaborator

Study Sites (1)

Sykehuset Innlandet Reinsvoll

Reinsvoll, 2840, Norway

Location

Related Publications (3)

• Orm S, Oie MG, Haugen I. Iowa Gambling Task performance in individuals with schizophrenia: the role of general versus specific cognitive abilities. Front Psychiatry. 2024 Dec 10;15:1454276. doi: 10.3389/fpsyt.2024.1454276. eCollection 2024.

  PMID: 39720440 DERIVED

• Oie MB, Haugen I, Stubberud J, Oie MG. Effects of Goal Management Training on self-efficacy, self-esteem, and quality of life for persons with schizophrenia spectrum disorders. Front Psychol. 2024 Mar 7;15:1320986. doi: 10.3389/fpsyg.2024.1320986. eCollection 2024.

  PMID: 38515967 DERIVED

• 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.

  PMID: 36031616 DERIVED

MeSH Terms

Conditions

Schizophrenia; Neurocognitive Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Merete G Øie, Phd

  Sykehuset Innlandet HF

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2017
• First Posted: February 9, 2017
• Study Start: May 18, 2017
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: February 10, 2021

Record last verified: 2021-02

Locations

NO (1)