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| Name | Class |
|---|---|
| Maastricht University | OTHER |
| UMC Groningen, Groningen, the Netherlands | UNKNOWN |
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Acquired brain injury (ABI) can lead to a wide range of physical, cognitive, emotional, and social problems. In the recent years, more research has been conducted to examine the impact of ABI on social cognition. Approximately 13%-40% of patients with ABI experience difficulties with social cognition. Social cognition refers to the cognitive processes involved in perceiving, interpreting, and responding to social information. When these processes are disrupted, patients may struggle to (1) understand social situations, (2) interpret the emotions and intentions of others, and (3) respond appropriately in social interactions. This not only results in reduced social engagement for ABI patients, but also places a burden on relationships and proxies. Therefore, it is important to effectively treat social cognition problems in ABI patients.
To date, only a few treatment studies aimed at improving social cognition have been conducted. In 2017, a multifaceted treatment for impairments in social cognition and emotion regulation (T-ScEmo) is developed, which was proven effective in improving multiple aspects of social cognition and emotion regulation. T-ScEmo is now considered as an evidence-based treatment for patients with traumatic brain injury and social cognition problems. However, ABI patients and comorbid neuropsychiatric problems have been excluded in most studies exploring the treatment of social cognition problems after ABI. It is important that the effect of T-ScEmo in this particular group is examined, since 25%-88% of the ABI patients experience neuropsychiatric problems. Comorbidities are thus very prevalent in this ABI population.
Unfortunately, up till now there are no studies examining the effect of T-ScEmo in patients with ABI, comorbid neuropsychiatric problems and social cognition problems. Therefore, the aim of the present study is threefold:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| There is only one arm in this study, since it is a SCED. | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment for social cognition disorders (T-ScEmo) | Behavioral | T-ScEmo is an evidence-based, multifaceted treatment protocol for poor social cognition and emotion regulation impairments in patients with ABI. T-ScEmo is implemented as standard practice in the Netherlands. In total, the treatment consists of 20 1-hour sessions. The treatment is divided into extended psychoeducation for patient and proxy and 3 modules, including emotion perception (module 1), perspective taking and understanding social information (module 2), and goal-directed social behavior (module 3). These three modules are interdependent and strengthen each other. Therefore, the developers strongly recommend to offer all three modules. The presence of a proxy is required in the first psycho-education session and during the third module. The first and second modules are invariant (10 sessions together), but in the third module, therapists can adjust the content to individual needs and personal goals. |
| Measure | Description | Time Frame |
|---|---|---|
| Social functioning - Social Functioning Scale (SFS) | Functioning in social situations is measured by using a Social Functioning Scale (SFS), where patients and proxies rate the patient's functioning in social situations on a 10-point scale from 1 ("not at all") to 10 ("entirely"). The following question will be asked to patients and proxies: "How satisfied are you today with your (or your partner's) functioning in social situations?" Higher scores indicate more satisfaction. | From enrollment to follow-up, approximately 12 months. |
| Neuropsychiatric behavior problems - Neuropsychiatric behavior Problems Scale (NPS) | Neuropsychiatric behavior problems are measured by using a Neuropsychiatric behavior Problems Scale (NPS), where patients and proxies rate the patient's neuropsychiatric behavior problems on a 10-point scale from 1 ("not at all") to 10 ("entirely"). The following question will be asked to patients and proxies: "To what extent did you (or your partner) experience neuropsychiatric behavioral problems today?". 'Neuropsychiatric behavioral problems' refer to the neuropsychiatric problems that the client is (most) affected by (e.g. irritability, aggression, disinhibition, depression, anxiety). Higher scores indicate more neuropsychiatric problems. | From enrollment to follow-up, approximately 12 months. |
| Relationship quality - Relationship Quality Scale (RQS) | Relationship quality is measured by using the Relationship Quality Scale (RQS), where patients and proxies rate the quality of their relationship on a 10-point scale from 1 ("not at all") to 10 ("entirely"). Higher scores indicate more satisfaction. | From enrollment to follow-up, approximately 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Executive functioning (social scales) | The Dysexecutive Questionnaire - Social scales (DEX-Soc-self; DEX-Soc-proxy) will be filled out by participant and proxy. The DEX subscales 'Meta cognition' (items 2, 5, 12, 16, 20), 'Social convention' (items 9, 12, 13, 20), and 'Behavioral emotional self-regulation' (items 3, 7, 8) will be filled out. The items are scored on a 4-point scale (0 = never to 4 = very often), with higher scores indicating more problems. |
| Measure | Description | Time Frame |
|---|---|---|
| Other neuropsychological tests | Other neuropsychological tests are used to assess possible effects of cognitive (dis)functioning on effectiveness of the treatment, neuropsychological tests on attention, executive functioning, and memory will be administered before treatment: Trail Making Test (TMT) A + B, TMT B/A; BADS Zoo-map; 15-word test. | At baseline |
Inclusion Criteria:
All patients:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GGZ Oost Brabant | Boekel | North Brabant | 5427EM | Netherlands |
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| At baseline, post-treatment (22-29 weeks), and follow-up (approximately 1 year after baseline) |
| Social monitoring | The Brock's Adaptive Functioning Questionnaire Social monitoring scale (BAFQ-SMself, BAFQ-SM-proxy) will be filled out by participant and proxy. The items are scored on a 5-point scale (1 = almost never to 5 = almost ever), with higher scores indicating more problems. | At baseline, post-treatment (22-29 weeks), and follow-up (approximately 1 year after baseline) |
| Empathy | The IRI (Interpersonal Reactivity Index) will be filled out by the participant. The IRI is a 28-item multidimensional scale that measures empathy. The scale measures both the cognitive and affective aspects of empathy. The IRI consists of 4 subscales, each containing 7 items. Higher scores indicate a higher level of empathy. The Brock's Adaptive Functioning Questionnaire Empathy scale (BAFQ-Emp-self, BAFQ-Emp-proxy) will be filled out by participant and proxy. The items are scored on a 5-point scale (1 = almost never to 5 = almost ever), with higher scores indicating more problems. | At baseline, post-treatment (22-29 weeks), and follow-up (approximately 1 year after baseline) |
| Neuropsychiatric problems | The Neuropsychiatrische Vragenlijst-Questionnaire (NPI-Q) will be filled out by the proxy. The NPI-Q is a validated questionnaire, aimed at inventorying neuropsychiatric symptoms that have occurred in the past month. For each domain, the answer is initially given as "Yes" (present) or "No" (absent). If the answer is "No," the informant proceeds to the next question. If the answer is "Yes," the informant assesses both the severity of the symptoms that occurred in the past month (three-point scale) and the psychological burden it caused for him or her (six-point scale). The NPI-Q provides a severity rating and an assessment of the emotional burden for each reported symptom, as well as summed total scores for Severity and Emotional Burden. Higher scores indicate more problems. | At baseline, post-treatment (22-29 weeks), and follow-up (approximately 1 year after baseline) |
| Cognitive Communication | The the La Trobe Questionnaire (LCQ-S / LCQ-O) will be filled out by participant and proxy. The LCQ-S is a 30-item self-report questionnaire that assesses perceived communication quality in patients with ABI. Items of the LCQ-O are the same as those that appear in de LCQ-S, except they are phrased in the third person. Higher scores indicate more problems. | At baseline, post-treatment (22-29 weeks), and follow-up (approximately 1 year after baseline) |
| Marital Satisfaction | The Dutch Marital Satisfaction and Communication Questionnaire (DMSCQ) will be filled out by participant and proxy. The DMSCQ is a 16-item questionnaire that disentangles marital satisfaction, negative communication and open communication on a 7-point scale ("not at all applicable" to "highly applicable") | At baseline, post-treatment (22-29 weeks), and follow-up (approximately 1 year after baseline) |
| Caregiver strain | The Caregiver Strain Index (CSI) will be filled out by the proxy to detect caregiver strain. The CSI is a 13-item questionnaire with dichotomous yes/no answers. Higher scores indicate more problems. | At baseline, post-treatment (22-29 weeks), and follow-up (approximately 1 year after baseline) |
| Recognition of facial affect | The FEEST (Sixty faces test) will be administered to test the recognition of facial affect. Participants are presented with 60 photographs of faces displaying the various primary emotions (happiness, sadness, fear, angst, disgust, and surprise), with 10 faces of each primary emotion. The photographs are shown for 3 seconds. Higher scores indicate a better performance. | At baseline, post-treatment (22-29 weeks), and follow-up (approximately 1 year after baseline) |
| Mental state attribution | The Cartoon test will be administered to test mental state attribution. The Cartoon test incorporates 12 cartoons displaying humorous situations. Higher scores indicate a better performance. | At baseline, post-treatment (22-29 weeks), and follow-up (approximately 1 year after baseline) |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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