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

Primary Purpose

Schizophrenia, Neurocognitive Disorders

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
GMT
Sponsored by
Sykehuset Innlandet HF
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

16 Years - 67 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sykehuset Innlandet Reinsvoll

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Goal Management Training

Waiting list

Arm Description

Cognitive rehabilitation

Outcomes

Primary Outcome Measures

Behavior Rating Inventory for Executive Functions
Assessing change
Conners Continuous Performance Test III
Assessing change
Positive and Negative Syndrome Scale
Assessing change

Secondary Outcome Measures

Global Assessment of Functioning-Split Version
Assessing change
The Hotel Task
Assessing change
Delis Kaplan Executive Function System (D-KEFS) subtests
Assessing change
Digit span and Letter-number sequencing
Assessing change
Iowa Gambling Task
Assessing change
Dysexecutive Questionnaire (self-and informant)
Assessing change
Cognitive Failures Questionnaire
Assessing change
Goal Attainment Scaling
Assessing change
Everyday Functioning from NORMENT Long time follow up questionnaires
Assessing change
General Perceived Self-Efficacy Scale
Assessing change
Social Functioning Scale
Assessing change
The Perceived Quality of Life Scale
Assessing change
Rosenberg self-esteem scale
Assessing change
Hopkins Symptom Checklist 10
Assessing change

Full Information

First Posted
January 16, 2017
Last Updated
February 9, 2021
Sponsor
Sykehuset Innlandet HF
Collaborators
University of Oslo
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1. Study Identification

Unique Protocol Identification Number
NCT03048695
Brief Title
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

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
May 18, 2017 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sykehuset Innlandet HF
Collaborators
University of Oslo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Neurocognitive Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Goal Management Training
Arm Type
Experimental
Arm Description
Cognitive rehabilitation
Arm Title
Waiting list
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
GMT
Intervention Description
Metacognitive strategy training where the primary objective is to stop ongoing behavior to define goal hierarchies and monitor performance
Primary Outcome Measure Information:
Title
Behavior Rating Inventory for Executive Functions
Description
Assessing change
Time Frame
Baseline, immediately post-intervention and 6 months follow-up
Title
Conners Continuous Performance Test III
Description
Assessing change
Time Frame
Baseline, immediately post-intervention and 6 months follow-up
Title
Positive and Negative Syndrome Scale
Description
Assessing change
Time Frame
Baseline, immediately post-intervention and 6 months follow-up
Secondary Outcome Measure Information:
Title
Global Assessment of Functioning-Split Version
Description
Assessing change
Time Frame
Baseline, immediately post-intervention and 6 months follow-up
Title
The Hotel Task
Description
Assessing change
Time Frame
Baseline, immediately post-intervention and 6 months follow-up
Title
Delis Kaplan Executive Function System (D-KEFS) subtests
Description
Assessing change
Time Frame
Baseline, immediately post-intervention and 6 months follow-up
Title
Digit span and Letter-number sequencing
Description
Assessing change
Time Frame
Baseline, immediately post-intervention and 6 months follow-up
Title
Iowa Gambling Task
Description
Assessing change
Time Frame
Baseline, immediately post-intervention and 6 months follow-up
Title
Dysexecutive Questionnaire (self-and informant)
Description
Assessing change
Time Frame
Baseline, immediately post-intervention and 6 months follow-up
Title
Cognitive Failures Questionnaire
Description
Assessing change
Time Frame
Baseline, immediately post-intervention and 6 months follow-up
Title
Goal Attainment Scaling
Description
Assessing change
Time Frame
Baseline, immediately post-intervention and 6 months follow-up
Title
Everyday Functioning from NORMENT Long time follow up questionnaires
Description
Assessing change
Time Frame
Baseline, immediately post-intervention and 6 months follow-up
Title
General Perceived Self-Efficacy Scale
Description
Assessing change
Time Frame
Baseline, immediately post-intervention and 6 months follow-up
Title
Social Functioning Scale
Description
Assessing change
Time Frame
Baseline, immediately post-intervention and 6 months follow-up
Title
The Perceived Quality of Life Scale
Description
Assessing change
Time Frame
Baseline, immediately post-intervention and 6 months follow-up
Title
Rosenberg self-esteem scale
Description
Assessing change
Time Frame
Baseline, immediately post-intervention and 6 months follow-up
Title
Hopkins Symptom Checklist 10
Description
Assessing change
Time Frame
Baseline, immediately post-intervention and 6 months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merete G Øie, Phd
Organizational Affiliation
Sykehuset Innlandet HF
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sykehuset Innlandet Reinsvoll
City
Reinsvoll
ZIP/Postal Code
2840
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
36031616
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.
Results Reference
derived

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

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