A Single-case Design to Investigate a Compensatory Brain Game Supporting Goal Management Training Intervention in a Psychiatric Brain Injury Population

NCT06352346 | Not Yet Recruiting DMC

• 1 other identifier: Plan Game_ABI&Psychiatry
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Acquired Brain Injury; Depressive Symptoms; Anxiety; Executive Dysfunction

Keywords

Goal Management Training; Compensatory Strategy Training; Serious Gaming

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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)

  pre-intervention, immediately following intervention and at six weeks follow-up

• Change in performance on two trained IADL task (treatment goals)

  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)

  pre-intervention, immediately following intervention and at six weeks follow-up

• Change in strategy use during the performance of trained and untrained IADL tasks

  pre-intervention, immediately following intervention and at six weeks follow-up

Study Arms (3)

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.

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.

Interventions

Compensatory brain game supporting Goal Management Training intervention BEHAVIORAL

o 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).

Experimental: Intervention phase (Phase B): Goal Management Training

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18 - 75 years
• Non-progressive acquired brain injury
• Minimal time post-onset of 3 months
• 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.

You may not qualify if:

• 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
• Neglect
• Unable to look at a computer screen for 15 minutes
• Unable to operate a keyboard or computer mouse

Sponsors & Collaborators

• ProPersona: lead

Study Sites (1)

ProPersona

Wolfheze, Gelderland, 6874 BE Wolfheze, Netherlands

Location

Related Publications (5)

• 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.

  PMID: 24050810 BACKGROUND

• Bertens 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.

  PMID: 26889801 BACKGROUND

• Dechamps 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.

  PMID: 21502092 BACKGROUND

• Frankenmolen 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.

  PMID: 30168408 BACKGROUND

• Lovibond 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.

  PMID: 7726811 BACKGROUND

MeSH Terms

Conditions

Brain Injuries; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Behavioral Symptoms; Behavior; Mental Disorders

Central Study Contacts

Helen Anema, PhD

CONTACT

+31264833 313; h.anema@propersona.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The target behavior (i.e. performance on an untrained shopping task) will be measured repeatedly, on a minimum of six occasions in each phase where possible, in accordance with the recommendations of the What Works Clearinghouse and RoBiNT criteria. Repeated measures of target behavior will be assessed via the OxMET-NL task and is scored automatically: no assessor input is required to either save or score the main outcome data. The secondary outcome measure(s) are scored by an outcome assessor who is blind to the order in which the secondary outcome measure(s) were taken.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: April 8, 2024
• Study Start: May 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 8, 2024

Record last verified: 2024-04

Locations

NL (1)