Acquired Brain InjuryNCT06923683
Treatment for Social Cognition Disorders (T-ScEmo) in Patients With Acquired Brain Injury and Comorbid Neuropsychiatric Problems
A study testing Treatment for social cognition disorders (T-ScEmo) in people with Acquired Brain Injury and Neuropsychiatric Symptoms, run by Ggz Oost Brabant at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acquired Brain Injury, Neuropsychiatric Symptoms
- What is being tested?
- Treatment for social cognition disorders (T-ScEmo)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jan 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients:
- have an established and documented history of ABI and current neuropsychiatric problems. When patients are referred to our institution, a team of clinical neuropsychologists, psychiatrists, and a high-educated nurse estimate whether patients meet these criteria by using a transdiagnostic tool.
- have social cognition problems. These impairments in social cognition are established by defective scores on the Facial Expression of Emotion-Stimuli and Tests (FEEST) and/or (if available) frontal lesions visible on computed tomographic scan/magnetic resonance image, indicating higher risk on social behavioral problems. The FEEST is already used in standard care.
- are at least 6 months post-injury to avoid the effects of spontaneous recovery.
- are between 18 and 70 years.
- have a significant other/proxy to fill in questionnaires and participate in the treatment. A life partner (persons living together in an intimate relationship, either married or unmarried) is preferred. When patients don't have a life partner, they are asked to bring an adult proxy (a close friend or family member) with whom they have frequent contact in daily life, preferably someone who already knew the patient from before the ABI.
Who cannot join
- not being able to receive the T-ScEmo treatment, for example due to severe cognitive impairment
- not speaking the Dutch language.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effectiveness of a Treatment for Social Cognition Disorders (T-ScEmo) in Patients With Acquired Brain Injury and Comorbid Neuropsychiatric Problems
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.
Read more
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:
- To examine the effect of a treatment for impairments in social cognition and emotion regulation (T-ScEmo) on social cognition problems;
- To examine the effect of T-ScEmo on social interaction, communication and neuropsychiatric behavioral problems;
- To examine the effect of T-ScEmo on quality of partner relationship in patients with ABI and comorbid psychiatric problems.
- Conditions
- Acquired Brain Injury, Neuropsychiatric Symptoms
- Being tested
- Treatment for social cognition disorders (T-ScEmo)
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment for social cognition disorders (T-ScEmo)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| There is only one arm in this study, since it is a SCED. | Experimental | Not described Receives: Behavioral: Treatment for social cognition disorders (T-ScEmo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: From enrollment to follow-up, approximately 12 months.
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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")
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At baseline, post-treatment (22-29 weeks), and follow-up (approximately 1 year after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start1 Jan 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ggz Oost Brabant
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University, UMC Groningen, Groningen, the Netherlands
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06923683
- Sponsor's protocol ID
- T-ScEmo SCED
- Status last verified
- Jan 2025
- First submitted
- 28 Feb 2025
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Raafs B, Westerhof-Evers M, van Heugten C, Spikman J, Rijnen S. T-ScEmo4ALL Plus+: Treatment for social cognition disorders in patients with acquired brain injury and neuropsychiatric problems - A single case experimental design (SCED) study protocol. PLoS One. 2026 Sep 18;21(9):e0358008. doi: 10.1371/journal.pone.0358008. eCollection 2026.
PubMed 42758671
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Treatment for Social Cognition Disorders (T-ScEmo) in Patients With Acquired Brain Injury and Comorbid Neuropsychiatric Problems
- ClinicalTrials.gov ID
- NCT06923683
- Acronym / sponsor ID
- T-ScEmo SCED
- Conditions
- Acquired Brain Injury, Neuropsychiatric Symptoms
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Ggz Oost BrabantUniversity, hospital or other
- Collaborators
- Maastricht University, UMC Groningen, Groningen, the Netherlands
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 11 Apr 2025 (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.
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:
- To examine the effect of a treatment for impairments in social cognition and emotion regulation (T-ScEmo) on social cognition problems;
- To examine the effect of T-ScEmo on social interaction, communication and neuropsychiatric behavioral problems;
- To examine the effect of T-ScEmo on quality of partner relationship in patients with ABI and comorbid psychiatric problems.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| There is only one arm in this study, since it is a SCED. | Experimental | Behavioral: Treatment for social cognition disorders (T-ScEmo) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- have an established and documented history of ABI and current neuropsychiatric problems. When patients are referred to our institution, a team of clinical neuropsychologists, psychiatrists, and a high-educated nurse estimate whether patients meet these criteria by using a transdiagnostic tool.
- have social cognition problems. These impairments in social cognition are established by defective scores on the Facial Expression of Emotion-Stimuli and Tests (FEEST) and/or (if available) frontal lesions visible on computed tomographic scan/magnetic resonance image, indicating higher risk on social behavioral problems. The FEEST is already used in standard care.
- are at least 6 months post-injury to avoid the effects of spontaneous recovery.
- are between 18 and 70 years.
- have a significant other/proxy to fill in questionnaires and participate in the treatment. A life partner (persons living together in an intimate relationship, either married or unmarried) is preferred. When patients don't have a life partner, they are asked to bring an adult proxy (a close friend or family member) with whom they have frequent contact in daily life, preferably someone who already knew the patient from before the ABI.
Key exclusion criteria (2 listed)
- not being able to receive the T-ScEmo treatment, for example due to severe cognitive impairment
- not speaking the Dutch language.
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 |
|---|---|---|
| Treatment for social cognition disorders (T-ScEmo)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. | Behavioural | There is only one arm in this study, since it is a SCED. |
Primary outcome
Social functioning - Social Functioning Scale (SFS)
Time frame: From enrollment to follow-up, approximately 12 months.
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.
Neuropsychiatric behavior problems - Neuropsychiatric behavior Problems Scale (NPS)
Time frame: From enrollment to follow-up, approximately 12 months.
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.
Relationship quality - Relationship Quality Scale (RQS)
Time frame: From enrollment to follow-up, approximately 12 months.
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.
9 secondary outcomes
Executive functioning (social scales)
Time frame: At baseline, post-treatment (22-29 weeks), and follow-up (approximately 1 year after baseline)
Social monitoring
Time frame: At baseline, post-treatment (22-29 weeks), and follow-up (approximately 1 year after baseline)
Empathy
Time frame: At baseline, post-treatment (22-29 weeks), and follow-up (approximately 1 year after baseline)
Neuropsychiatric problems
Time frame: At baseline, post-treatment (22-29 weeks), and follow-up (approximately 1 year after baseline)
Cognitive Communication
Time frame: At baseline, post-treatment (22-29 weeks), and follow-up (approximately 1 year after baseline)
Marital Satisfaction
Time frame: At baseline, post-treatment (22-29 weeks), and follow-up (approximately 1 year after baseline)
Caregiver strain
Time frame: At baseline, post-treatment (22-29 weeks), and follow-up (approximately 1 year after baseline)
Recognition of facial affect
Time frame: At baseline, post-treatment (22-29 weeks), and follow-up (approximately 1 year after baseline)
Mental state attribution
Time frame: At baseline, post-treatment (22-29 weeks), and follow-up (approximately 1 year after baseline)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Derived from this study: PubMed 42758671Raafs B, Westerhof-Evers M, van Heugten C, Spikman J, Rijnen S. T-ScEmo4ALL Plus+: Treatment for social cognition disorders in patients with acquired brain injury and neuropsychiatric problems - A single case experimental design (SCED) study protocol. PLoS One. 2026 Sep 18;21(9):e0358008. doi: 10.1371/journal.pone.0358008. eCollection 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment for social cognition disorders (T-ScEmo) in people with Acquired Brain Injury and Neuropsychiatric Symptoms, run by Ggz Oost Brabant 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 2 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: enrolling by invitation, as of the sponsor's last update on 17 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Social functioning - Social Functioning Scale (SFS) (time frame: From enrollment to follow-up, approximately 12 months.). 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 NCT06923683, which also lists 1 linked publication.
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 17 Apr 2025.