Acquired Brain InjuryNCT06352346
A Single-case Design to Investigate a Compensatory Brain Game Supporting Goal Management Training Intervention in a Psychiatric Brain Injury Population
A study testing Compensatory brain game supporting Goal Management Training intervention in people with Acquired Brain Injury and Depressive Symptoms, run by ProPersona at 1 site in Netherlands.
Trial summary
The main cognitive complaint in brain-injured patients is often the everyday disorganization caused by Executive Function (EF) deficits. EF deficits are often seen in patients with psychiatric disorders i.e. depression or anxiety. In order to minimize everyday disorganization, effective EF interventions are required. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acquired Brain Injury, Depressive Symptoms, Anxiety
- What is being tested?
- Compensatory brain game supporting Goal Management Training intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2024to Dec 2025
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 - 75 years
- Non-progressive acquired brain injury
- Minimal time post-onset of 3 months
- Receive inpatient neuropsychiatric care at the time of inclusion
- Executive deficits (neuropsychological assessment)
- Reasonable amount of awareness in their deficits, at least to the extent that they are motivated and capable to learn new skills with respect to their executive performance.
Who cannot join
- Inability to speak/understand the Dutch language
- Severe psychiatric disorders such as psychosis, manic episode, severe disruptive behavior
- Neurodegenerative disorders (i.e. dementia, Huntington, Parkinson
- Substance abuse (active)
- Severe cognitive comorbidity (i.e. Korsakov)
- Aphasia
Show all 9Show fewer
- Neglect
- Unable to look at a computer screen for 15 minutes
- Unable to operate a keyboard or computer mouse
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
ProPersona
Wolfheze, Gelderland, 6874 BE Wolfheze
Bea Tiemens, PhD, b.tiemens@propersona.nl
Floor Poerschke, MSc
About this study
Official title: Evaluation of a Compensatory Brain Game Supporting Goal Management Training Intervention Targeting Executive Function in Acquired Brain Injury Patients With Depressive and/or Anxiety Symptoms: a Single-case Experimental Design
The main cognitive complaint in brain-injured patients is often the everyday disorganization caused by Executive Function (EF) deficits. EF deficits are often seen in patients with psychiatric disorders i.e. depression or anxiety. In order to minimize everyday disorganization, effective EF interventions are required. Interventions using compensatory strategies have the potential to enable patients to minimize disabilities, minimize participation problems and to function more independently in daily life. A well-known evidence-based intervention that uses compensatory strategies is Goal Management Training (GMT), a training that has been found to alleviate depressive symptoms in a depressed population. GMT entails learning and applying an algorithm, in which a daily task is subdivided into multiple steps to handle executive difficulties of planning, and problem solving. To adopt the GMT strategy and ensure maximal profitability for patients, they have to learn to use the algorithm in different situations and tasks. Therefore, GMT is comprehensive, time-consuming and thus labour-intensive. Along with this, brain games become increasingly attractive as an (add-on) intervention, most notably in an effort to develop home-based personalized care. Until now, however, the rationale behind brain games is based on what can be considered the restorative approach (i.e. strengthening of executive problems) rather than practicing compensatory strategies, with little or no transfer to improvements in daily life functioning. This study therefore aims to assess the potential of a newly developed Brain Game, based on compensatory strategies, as an add-on to GMT to develop a shortened and partly self-paced GMT intervention. The primary objective of this study is to assess whether the use of a compensatory brain game supported GMT treatment could be of interest in people with EF deficits after ABI that also suffer from depression or anxiety, to improve goal achievement, their executive function performance during goal-related tasks, and their executive performance during an ecological valid shopping task. Also we assess whether psychological symptoms alleviate following the GMT intervention and at 6-weeks follow-up. The study will be a multiple-baseline across individuals single-case experimental design (SCED). The study population consists of brain-injured patients, between 18 and 75 years old that receive in-patient mental neuropsychiatric healthcare. Participants eligible for the study must have EF deficits due to (nonprogressive) Acquired Brain Injury (ABI), minumum time post-onset of 3 months and depressive or anxiety symptoms. EF deficits will be assessed by extensive neuropsychological examination. Participants will be recruited from an inpatient clinic. In the course of one and a half year four participants will be recruited.
Read the detailed description
Not provided
- Being tested
- Compensatory brain game supporting Goal Management Training intervention
- Keywords
- Goal Management Training, Compensatory Strategy Training, Serious Gaming
- Medical subject headings
- Brain Injuries, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compensatory brain game supporting Goal Management Training interventionBehavioural
- The investigational treatment is only given during the intervention phase (phase B), and consists of six treatment sessions. In the treatment sessions, patients learn and apply the GMT algorithm. This means that the multiple steps of the GMT as well as the actual performance of the IADL-task goals will be learned under guidance of a therapist. In order to facilitate generalization, patients will learn to use the algorithm during the performance of untrained tasks by playing the treatment supporting Plan Game. Because of this, patients are able to practice the application of the GMT algorithm independently outside the therapy session. Besides, the intervention also includes a Plan Tool. This is a mobile application that can be used as an aid during the performance of (instrumental) activities of daily living (IADL) tasks in order to perform activities more independently. The GMT treatment sessions are given twice a week (max. 60 minutes for each attendance).
| Study group | Role | What they receive |
|---|---|---|
| No Intervention: Baseline phase (Phase A) | No intervention | o At the start of the study, all participants are assigned to the baseline phase (phase A). During phase A, patients do not receive interventions related to executive function problems. The start of the intervention phase (phase B) is determined randomly for each participant, given the restriction that phase A should last for at least three weeks (21 days) and at most five weeks (30 days). This means that phase B can start on any day between the 21th and the 30th days, resulting in a total of 10 possible assignments. So, in the first three weeks, all participants are in phase A. The duration of phase A will thus be different for each subject. Phase A acts as a control and is therefore compared with phase B. |
| Experimental: Intervention phase (Phase B): Goal Management Training | Experimental | During the intervention phase (phase B), all included participants will have 6 sessions of Goal Management Training (GMT; twice per week) in which two individual chosen IADL-tasks will be subdivided into multiple steps under guidance of a therapist using the GMT method. In addition participants play the compensatory brain game in which they are challenged to apply the learned GMT strategy in an imaginary and safe environment. Receives: Behavioral: Compensatory brain game supporting Goal Management Training intervention |
| Follow-up period | No intervention | A follow-up period of six weeks takes place after phase B. During this follow-up period, patients receive no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in performance on the Oxford Multiple Errands Test- Dutch version (OxMET-NL) from phase A to phase B
The target behavior will be assessed repeatedly, on a minimum of six occasions in phase A and B, in accordance with the recommendations of the What Works Clearinghouse and RoBiNT criteria (Tate et al., 2013). The OxMET-NL task is a computer-tablet based version of the Multiple Errands Test and is scored automatically. The task requires patients to buy six items and to answer two questions. The main outcome measure of the task is accuracy which ranges from -10 to + 10 (higher score is better outcome) based on a score obtained in each shop.
Measured: The target behavior (i.e. performance on the OxMET-NL) will be measured repeatedly, two times a week, for the duration of phase A (3 to 5 weeks) and phase B (36 weeks
Secondary outcomes (7)
Change on the Visual Analogue Scale (VAS) from phase A to phase B to follow-up
Subjective experience of strategy use in daily life and during the performance of instrumental activities of daily living (IADL) and three psychological symptoms. Scale ranges from 0-100 of which higher scores means better outcome.
Measured: The VAS will be assessed repeatedly, two times a week, for the duration of phase A (3 to 5 weeks), phase B (3 weeks) and follow-up (6 weeks)
Change in performance on treatment goals as measured with the Goal Attainment Scale (GAS)
GAS is a mathematical technique for quantifying the achievement of goals set, used in rehabilitation. GAS is described as a method of scoring the extent to which patient's individual goals are achieved in the course of intervention. In effect, each patient has his or her own outcome measure, but this is scored in a standardized way as to allow statistical analysis. The achievement of each goal (IADL-task) can be measured on a 5-point scale ranging from -2 to +2. Outcomes can be quantified in a single aggregated goal attainment score. This method gives a numerical T-score which is normally distributed about a mean of 50 (if the goals are achieved precisely) with a standard deviation of around this mean of 10 (if the goals are overachieved or underachieved).
Measured: pre-intervention, immediately following intervention and at six weeks follow-up
Change in performance on two trained IADL task (treatment goals)
Performance on two treatment goals is measured with a standardised scale . The tasks will be divided into multiple steps using the GMT method. Each task step will be assessed following a 3-point scale (ranging from 2=competent to 0=deficit). Total scores per task will be adjusted to a 100-point scale using the following formula: performance = (total score / (number of steps × 2)) × 100. Thus, a performance of 100% indicating perfect IADL task performance.
Measured: pre-intervention, immediately following intervention and at six weeks follow-up
Change in everyday difficulties in activities/participation as measured on the Daily Living Questionnaire (DLQ-R-NL)
The Dutch version of the Daily Living Questionnaire measures how much mental or cognitive difficulty the participant generally has by performing daily activities. Scale ranges from 0-112 of which higher scores means better outcome.
Measured: pre-intervention, immediately following intervention and at six weeks follow-up
Change in strategy use during the performance of trained and untrained IADL tasks
A self-designed questionnaire to examine self-reported strategy use will also be administered after the performance of the trained and untrained IADL tasks in order to measure strategy use in a traditional memory task. First, participants are openly asked which strategies they use during the performance of an IADL task. Subsequently, they are given a list with possible strategy components of GMT that one could use to perform a task and are asked to place a check mark next to each strategy that they had used.
Measured: pre-intervention, immediately following intervention and at six weeks follow-up
Change in subjective experience of strategy use in daily life
GMT strategy use is assessed through an adjustment of the Strategy Use Inventory; SUI . Participants have to indicate how often they use a certain strategy in daily life situations using a 5-point rating scale ranging from 1 (never) to 5 (often) which implies that higher scores mean better outcome. Average item scores are calculated
Measured: pre-intervention, immediately following intervention and at six weeks follow-up
Change in subjectively experienced psychological symptoms such as depressive, anxiety and stress symptoms.
Psychological symptoms are measured with the DASS-42. The DASS is a 42-item self-report instrument designed to measure the three related negative emotional states of depression, anxiety and tension/stress on a 4-point rating scale Subscale scores are calculated by summarizing the item scores, ranging from 0-42. A higher score means worse outcome.
Measured: pre-intervention, immediately following intervention and at six weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study startMay 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acquired Brain InjuryStudies 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
- Crossover
- Model description
- A randomized Single-case Experimental Design (SCED) with a follow-up period of 6 weeks. Participants will be first assigned to a baseline phase (phase A). The start of the treatment phase (phase B) is determined randomly for each participant, given the restriction that the baseline phase (phase A) should last for at least three weeks (21 days) and at most five weeks (30 days). This means that the treatment phase can start on any day between the 21th and the 30th days. So, in the first three weeks, all participants are in the baseline condition. The duration of baseline will thus be different for each subject. Nonspecific effects, such as linear trends, retesting or non-specific recovery, can be controlled by this approach, since expected changes in level of performance due to treatment should parallel this stepwise onset of therapy procedure. Phase A acts as a control and is therefore compared with phase B.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ProPersona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helen Alexandra Anema, ProPersona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06352346
- Sponsor's protocol ID
- Plan Game_ABI&Psychiatry
- Status last verified
- Apr 2024
- First submitted
- 29 Mar 2024
- Last updated
- 8 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tate RL, Perdices M, Rosenkoetter U, Wakim D, Godbee K, Togher L, McDonald S. Revision of a method quality rating scale for single-case experimental designs and n-of-1 trials: the 15-item Risk of Bias in N-of-1 Trials (RoBiNT) Scale. Neuropsychol Rehabil. 2013;23(5):619-38. doi: 10.1080/09602011.2013.824383. Epub 2013 Sep 9.
PubMed 24050810Bertens D, Kessels RP, Boelen DH, Fasotti L. Transfer effects of errorless Goal Management Training on cognitive function and quality of life in brain-injured persons. NeuroRehabilitation. 2016;38(1):79-84. doi: 10.3233/NRE-151298.
PubMed 26889801Dechamps A, Fasotti L, Jungheim J, Leone E, Dood E, Allioux A, Robert PH, Gervais X, Maubourguet N, Olde Rikkert MG, Kessels RP. Effects of different learning methods for instrumental activities of daily living in patients with Alzheimer's dementia: a pilot study. Am J Alzheimers Dis Other Demen. 2011 Jun;26(4):273-81. doi: 10.1177/1533317511404394. Epub 2011 Apr 17.
PubMed 21502092Frankenmolen NL, Overdorp EJ, Fasotti L, Claassen JAHR, Kessels RPC, Oosterman JM. Memory Strategy Training in Older Adults with Subjective Memory Complaints: A Randomized Controlled Trial. J Int Neuropsychol Soc. 2018 Nov;24(10):1110-1120. doi: 10.1017/S1355617718000619. Epub 2018 Aug 31.
PubMed 30168408Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.
PubMed 7726811
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Compensatory Brain Game Supporting Goal Management Training Intervention Targeting Executive Function in Acquired Brain Injury Patients With Depressive and/or Anxiety Symptoms: a Single-case Experimental Design
- ClinicalTrials.gov ID
- NCT06352346
- Acronym / sponsor ID
- Plan Game_ABI&Psychiatry
- Keywords
- Goal Management Training, Compensatory Strategy Training, Serious Gaming
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- ProPersonaUniversity, hospital or other
- Study start
- May 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 8 Apr 2024 (actual)
- 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.
The main cognitive complaint in brain-injured patients is often the everyday disorganization caused by Executive Function (EF) deficits. EF deficits are often seen in patients with psychiatric disorders i.e. depression or anxiety. In order to minimize everyday disorganization, effective EF interventions are required. Interventions using compensatory strategies have the potential to enable patients to minimize disabilities, minimize participation problems and to function more independently in daily life. A well-known evidence-based intervention that uses compensatory strategies is Goal Management Training (GMT), a training that has been found to alleviate depressive symptoms in a depressed population. GMT entails learning and applying an algorithm, in which a daily task is subdivided into multiple steps to handle executive difficulties of planning, and problem solving. To adopt the GMT strategy and ensure maximal profitability for patients, they have to learn to use the algorithm in different situations and tasks. Therefore, GMT is comprehensive, time-consuming and thus labour-intensive. Along with this, brain games become increasingly attractive as an (add-on) intervention, most notably in an effort to develop home-based personalized care. Until now, however, the rationale behind brain games is based on what can be considered the restorative approach (i.e. strengthening of executive problems) rather than practicing compensatory strategies, with little or no transfer to improvements in daily life functioning. This study therefore aims to assess the potential of a newly developed Brain Game, based on compensatory strategies, as an add-on to GMT to develop a shortened and partly self-paced GMT intervention. The primary objective of this study is to assess whether the use of a compensatory brain game supported GMT treatment could be of interest in people with EF deficits after ABI that also suffer from depression or anxiety, to improve goal achievement, their executive function performance during goal-related tasks, and their executive performance during an ecological valid shopping task. Also we assess whether psychological symptoms alleviate following the GMT intervention and at 6-weeks follow-up. The study will be a multiple-baseline across individuals single-case experimental design (SCED). The study population consists of brain-injured patients, between 18 and 75 years old that receive in-patient mental neuropsychiatric healthcare. Participants eligible for the study must have EF deficits due to (nonprogressive) Acquired Brain Injury (ABI), minumum time post-onset of 3 months and depressive or anxiety symptoms. EF deficits will be assessed by extensive neuropsychological examination. Participants will be recruited from an inpatient clinic. In the course of one and a half year four participants will be recruited.
Detailed description
Not provided
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- A randomized Single-case Experimental Design (SCED) with a follow-up period of 6 weeks. Participants will be first assigned to a baseline phase (phase A). The start of the treatment phase (phase B) is determined randomly for each participant, given the restriction that the baseline phase (phase A) should last for at least three weeks (21 days) and at most five weeks (30 days). This means that the treatment phase can start on any day between the 21th and the 30th days. So, in the first three weeks, all participants are in the baseline condition. The duration of baseline will thus be different for each subject. Nonspecific effects, such as linear trends, retesting or non-specific recovery, can be controlled by this approach, since expected changes in level of performance due to treatment should parallel this stepwise onset of therapy procedure. Phase A acts as a control and is therefore compared with phase B.
| Arm | Type | Receives |
|---|---|---|
| No Intervention: Baseline phase (Phase A) | No intervention | –o At the start of the study, all participants are assigned to the baseline phase (phase A). During phase A, patients do not receive interventions related to executive function problems. The start of the intervention phase (phase B) is determined randomly for each participant, given the restriction that phase A should last for at least three weeks (21 days) and at most five weeks (30 days). This means that phase B can start on any day between the 21th and the 30th days, resulting in a total of 10 possible assignments. So, in the first three weeks, all participants are in phase A. The duration of phase A will thus be different for each subject. Phase A acts as a control and is therefore compared with phase B. |
| Experimental: Intervention phase (Phase B): Goal Management Training | Experimental | Behavioral: Compensatory brain game supporting Goal Management Training interventionDuring the intervention phase (phase B), all included participants will have 6 sessions of Goal Management Training (GMT; twice per week) in which two individual chosen IADL-tasks will be subdivided into multiple steps under guidance of a therapist using the GMT method. In addition participants play the compensatory brain game in which they are challenged to apply the learned GMT strategy in an imaginary and safe environment. |
| Follow-up period | No intervention | –A follow-up period of six weeks takes place after phase B. During this follow-up period, patients receive no intervention. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age: 18 - 75 years
- Non-progressive acquired brain injury
- Minimal time post-onset of 3 months
- Receive inpatient neuropsychiatric care at the time of inclusion
- Executive deficits (neuropsychological assessment)
Key exclusion criteria (9 listed)
- Inability to speak/understand the Dutch language
- Severe psychiatric disorders such as psychosis, manic episode, severe disruptive behavior
- Neurodegenerative disorders (i.e. dementia, Huntington, Parkinson
- Substance abuse (active)
- Severe cognitive comorbidity (i.e. Korsakov)
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 |
|---|---|---|
| Compensatory brain game supporting Goal Management Training interventiono The investigational treatment is only given during the intervention phase (phase B), and consists of six treatment sessions. In the treatment sessions, patients learn and apply the GMT algorithm. This means that the multiple steps of the GMT as well as the actual performance of the IADL-task goals will be learned under guidance of a therapist. In order to facilitate generalization, patients will learn to use the algorithm during the performance of untrained tasks by playing the treatment supporting Plan Game. Because of this, patients are able to practice the application of the GMT algorithm independently outside the therapy session. Besides, the intervention also includes a Plan Tool. This is a mobile application that can be used as an aid during the performance of (instrumental) activities of daily living (IADL) tasks in order to perform activities more independently. The GMT treatment sessions are given twice a week (max. 60 minutes for each attendance). | Behavioural | Experimental: Intervention phase (Phase B): Goal Management Training |
Primary outcome
Change in performance on the Oxford Multiple Errands Test- Dutch version (OxMET-NL) from phase A to phase B
Time frame: The target behavior (i.e. performance on the OxMET-NL) will be measured repeatedly, two times a week, for the duration of phase A (3 to 5 weeks) and phase B (36 weeks
The target behavior will be assessed repeatedly, on a minimum of six occasions in phase A and B, in accordance with the recommendations of the What Works Clearinghouse and RoBiNT criteria (Tate et al., 2013). The OxMET-NL task is a computer-tablet based version of the Multiple Errands Test and is scored automatically. The task requires patients to buy six items and to answer two questions. The main outcome measure of the task is accuracy which ranges from -10 to + 10 (higher score is better outcome) based on a score obtained in each shop.
7 secondary outcomes
Change on the Visual Analogue Scale (VAS) from phase A to phase B to follow-up
Time frame: The VAS will be assessed repeatedly, two times a week, for the duration of phase A (3 to 5 weeks), phase B (3 weeks) and follow-up (6 weeks)
Change in performance on treatment goals as measured with the Goal Attainment Scale (GAS)
Time frame: pre-intervention, immediately following intervention and at six weeks follow-up
Change in performance on two trained IADL task (treatment goals)
Time frame: pre-intervention, immediately following intervention and at six weeks follow-up
Change in everyday difficulties in activities/participation as measured on the Daily Living Questionnaire (DLQ-R-NL)
Time frame: pre-intervention, immediately following intervention and at six weeks follow-up
Change in strategy use during the performance of trained and untrained IADL tasks
Time frame: pre-intervention, immediately following intervention and at six weeks follow-up
Change in subjective experience of strategy use in daily life
Time frame: pre-intervention, immediately following intervention and at six weeks follow-up
Change in subjectively experienced psychological symptoms such as depressive, anxiety and stress symptoms.
Time frame: pre-intervention, immediately following intervention and at six weeks follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
- Background: PubMed 24050810Tate RL, Perdices M, Rosenkoetter U, Wakim D, Godbee K, Togher L, McDonald S. Revision of a method quality rating scale for single-case experimental designs and n-of-1 trials: the 15-item Risk of Bias in N-of-1 Trials (RoBiNT) Scale. Neuropsychol Rehabil. 2013;23(5):619-38. doi: 10.1080/09602011.2013.824383. Epub 2013 Sep 9.
- Background: PubMed 26889801Bertens D, Kessels RP, Boelen DH, Fasotti L. Transfer effects of errorless Goal Management Training on cognitive function and quality of life in brain-injured persons. NeuroRehabilitation. 2016;38(1):79-84. doi: 10.3233/NRE-151298.
- Background: PubMed 21502092Dechamps A, Fasotti L, Jungheim J, Leone E, Dood E, Allioux A, Robert PH, Gervais X, Maubourguet N, Olde Rikkert MG, Kessels RP. Effects of different learning methods for instrumental activities of daily living in patients with Alzheimer's dementia: a pilot study. Am J Alzheimers Dis Other Demen. 2011 Jun;26(4):273-81. doi: 10.1177/1533317511404394. Epub 2011 Apr 17.
- Background: PubMed 30168408Frankenmolen NL, Overdorp EJ, Fasotti L, Claassen JAHR, Kessels RPC, Oosterman JM. Memory Strategy Training in Older Adults with Subjective Memory Complaints: A Randomized Controlled Trial. J Int Neuropsychol Soc. 2018 Nov;24(10):1110-1120. doi: 10.1017/S1355617718000619. Epub 2018 Aug 31.
- Background: PubMed 7726811Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compensatory brain game supporting Goal Management Training intervention in people with Acquired Brain Injury and Depressive Symptoms, run by ProPersona at 1 site in Netherlands.
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 6 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 8 Apr 2024. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Helen Anema, PhD (+31264833 313, h.anema@propersona.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in performance on the Oxford Multiple Errands Test- Dutch version (OxMET-NL) from phase A to phase B (time frame: The target behavior (i.e. performance on the OxMET-NL) will be measured repeatedly, two times a week, for the duration of phase A (3 to 5 weeks) and phase B (36 weeks). 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 NCT06352346, which also lists 5 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 8 Apr 2024.