SchizophreniaNCT03048695
Goal Management Training for Patients With Schizophrenia or High Risk for Schizophrenia
A study testing GMT in people with Schizophrenia and Neurocognitive Disorders, run by Sykehuset Innlandet HF at 1 site in Norway.
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… Read more about this study
- Who is it for?
- Ages 16 to 67 years
- Conditions the study is for
- Schizophrenia, Neurocognitive Disorders
- What is being tested?
- GMT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteNorway
- Study dates
- 18 May 2017to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 67 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cognitive Remediation of Executive Dysfunction - 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?
- Conditions
- Schizophrenia, Neurocognitive Disorders
- Being tested
- GMT
- Medical subject headings
- Schizophrenia, Neurocognitive Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GMTBehavioural
Metacognitive strategy training where the primary objective is to stop ongoing behavior to define goal hierarchies and monitor performance
| Study group | Role | What they receive |
|---|---|---|
| Goal Management Training | Experimental | Cognitive rehabilitation Receives: Behavioral: GMT |
| Waiting list | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavior Rating Inventory for Executive Functions
Assessing change
Measured: Baseline, immediately post-intervention and 6 months follow-up
Conners Continuous Performance Test III
Assessing change
Measured: Baseline, immediately post-intervention and 6 months follow-up
Positive and Negative Syndrome Scale
Assessing change
Measured: Baseline, immediately post-intervention and 6 months follow-up
Secondary outcomes (14)
Global Assessment of Functioning-Split Version
Assessing change
Measured: Baseline, immediately post-intervention and 6 months follow-up
The Hotel Task
Assessing change
Measured: Baseline, immediately post-intervention and 6 months follow-up
Delis Kaplan Executive Function System (D-KEFS) subtests
Assessing change
Measured: Baseline, immediately post-intervention and 6 months follow-up
Digit span and Letter-number sequencing
Assessing change
Measured: Baseline, immediately post-intervention and 6 months follow-up
Iowa Gambling Task
Assessing change
Measured: Baseline, immediately post-intervention and 6 months follow-up
Dysexecutive Questionnaire (self-and informant)
Assessing change
Measured: Baseline, immediately post-intervention and 6 months follow-up
Cognitive Failures Questionnaire
Assessing change
Measured: Baseline, immediately post-intervention and 6 months follow-up
Goal Attainment Scaling
Assessing change
Measured: Baseline, immediately post-intervention and 6 months follow-up
Everyday Functioning from NORMENT Long time follow up questionnaires
Assessing change
Measured: Baseline, immediately post-intervention and 6 months follow-up
General Perceived Self-Efficacy Scale
Assessing change
Measured: Baseline, immediately post-intervention and 6 months follow-up
Social Functioning Scale
Assessing change
Measured: Baseline, immediately post-intervention and 6 months follow-up
The Perceived Quality of Life Scale
Assessing change
Measured: Baseline, immediately post-intervention and 6 months follow-up
Rosenberg self-esteem scale
Assessing change
Measured: Baseline, immediately post-intervention and 6 months follow-up
Hopkins Symptom Checklist 10
Assessing change
Measured: Baseline, immediately post-intervention and 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study start18 May 2017
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sykehuset Innlandet HF
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Responsible party
- Sponsor
- Investigators
- Merete G Øie, Phd, Principal investigator, Sykehuset Innlandet HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03048695
- Sponsor's protocol ID
- 150601
- Status last verified
- Feb 2021
- First submitted
- 16 Jan 2017
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39720440Oie 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.
PubMed 38515967Haugen 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.
PubMed 36031616
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Remediation of Executive Dysfunction - Goal Management Training for Patients With Schizophrenia or High Risk for Schizophrenia
- ClinicalTrials.gov ID
- NCT03048695
- Acronym / sponsor ID
- 150601
- Conditions
- Schizophrenia, Neurocognitive Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Sykehuset Innlandet HFUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- 18 May 2017 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 9 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Goal Management Training | Experimental | Behavioral: GMTCognitive rehabilitation |
| Waiting list | No intervention | – |
Who may qualify
- Ages
- 16 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GMTMetacognitive strategy training where the primary objective is to stop ongoing behavior to define goal hierarchies and monitor performance | Behavioural | Goal Management Training |
Primary outcome
Behavior Rating Inventory for Executive Functions
Time frame: Baseline, immediately post-intervention and 6 months follow-up
Assessing change
Conners Continuous Performance Test III
Time frame: Baseline, immediately post-intervention and 6 months follow-up
Assessing change
Positive and Negative Syndrome Scale
Time frame: Baseline, immediately post-intervention and 6 months follow-up
Assessing change
14 secondary outcomes
Global Assessment of Functioning-Split Version
Time frame: Baseline, immediately post-intervention and 6 months follow-up
The Hotel Task
Time frame: Baseline, immediately post-intervention and 6 months follow-up
Delis Kaplan Executive Function System (D-KEFS) subtests
Time frame: Baseline, immediately post-intervention and 6 months follow-up
Digit span and Letter-number sequencing
Time frame: Baseline, immediately post-intervention and 6 months follow-up
Iowa Gambling Task
Time frame: Baseline, immediately post-intervention and 6 months follow-up
Dysexecutive Questionnaire (self-and informant)
Time frame: Baseline, immediately post-intervention and 6 months follow-up
Cognitive Failures Questionnaire
Time frame: Baseline, immediately post-intervention and 6 months follow-up
Goal Attainment Scaling
Time frame: Baseline, immediately post-intervention and 6 months follow-up
Everyday Functioning from NORMENT Long time follow up questionnaires
Time frame: Baseline, immediately post-intervention and 6 months follow-up
General Perceived Self-Efficacy Scale
Time frame: Baseline, immediately post-intervention and 6 months follow-up
Social Functioning Scale
Time frame: Baseline, immediately post-intervention and 6 months follow-up
The Perceived Quality of Life Scale
Time frame: Baseline, immediately post-intervention and 6 months follow-up
Rosenberg self-esteem scale
Time frame: Baseline, immediately post-intervention and 6 months follow-up
Hopkins Symptom Checklist 10
Time frame: Baseline, immediately post-intervention and 6 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Derived from this study: PubMed 39720440Orm 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.
- Derived from this study: PubMed 38515967Oie 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.
- Derived from this study: PubMed 36031616Haugen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merete G Øie, Phd principal investigator
Sykehuset Innlandet HF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GMT in people with Schizophrenia and Neurocognitive Disorders, run by Sykehuset Innlandet HF at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavior Rating Inventory for Executive Functions (time frame: Baseline, immediately post-intervention and 6 months follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03048695, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2021.