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OpenTrials
Completed

NCT Number: NCT03048695

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?

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Key information

Age range

16 year–67 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sykehuset Innlandet Reinsvoll

Reinsvoll, 2840, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GMT

Behavioral

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

Primary outcomes

  1. Behavior Rating Inventory for Executive Functions

    Time frame: Baseline, immediately post-intervention and 6 months follow-up

    Assessing change

  2. Conners Continuous Performance Test III

    Time frame: Baseline, immediately post-intervention and 6 months follow-up

    Assessing change

  3. Positive and Negative Syndrome Scale

    Time frame: Baseline, immediately post-intervention and 6 months follow-up

    Assessing change

Secondary outcomes

  1. Global Assessment of Functioning-Split Version

    Time frame: Baseline, immediately post-intervention and 6 months follow-up

    Assessing change

  2. The Hotel Task

    Time frame: Baseline, immediately post-intervention and 6 months follow-up

    Assessing change

  3. Delis Kaplan Executive Function System (D-KEFS) subtests

    Time frame: Baseline, immediately post-intervention and 6 months follow-up

    Assessing change

  4. Digit span and Letter-number sequencing

    Time frame: Baseline, immediately post-intervention and 6 months follow-up

    Assessing change

  5. Iowa Gambling Task

    Time frame: Baseline, immediately post-intervention and 6 months follow-up

    Assessing change

  6. Dysexecutive Questionnaire (self-and informant)

    Time frame: Baseline, immediately post-intervention and 6 months follow-up

    Assessing change

  7. Cognitive Failures Questionnaire

    Time frame: Baseline, immediately post-intervention and 6 months follow-up

    Assessing change

  8. Goal Attainment Scaling

    Time frame: Baseline, immediately post-intervention and 6 months follow-up

    Assessing change

  9. Everyday Functioning from NORMENT Long time follow up questionnaires

    Time frame: Baseline, immediately post-intervention and 6 months follow-up

    Assessing change

  10. General Perceived Self-Efficacy Scale

    Time frame: Baseline, immediately post-intervention and 6 months follow-up

    Assessing change

  11. Social Functioning Scale

    Time frame: Baseline, immediately post-intervention and 6 months follow-up

    Assessing change

  12. The Perceived Quality of Life Scale

    Time frame: Baseline, immediately post-intervention and 6 months follow-up

    Assessing change

  13. Rosenberg self-esteem scale

    Time frame: Baseline, immediately post-intervention and 6 months follow-up

    Assessing change

  14. Hopkins Symptom Checklist 10

    Time frame: Baseline, immediately post-intervention and 6 months follow-up

    Assessing change

Sponsors and collaborators

Lead sponsor

Sykehuset Innlandet HF

Other

Collaborators

  • University of Oslo

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Feb 9, 2017
Registry last updated
Feb 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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