Effectiveness of a social cognition treatment (T-ScEmo) in patients with moderate to severe traumatic brain injury

The effectiveness of the Treatment op Social cognition and Emotion regulation (T-ScEmo) compared to training of attention (CogniPlus) on social functioning (i.e. social cognition performances, behavioral complaints, participation and quality of life) after moderate to severe traumatic brain injury: a randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN81350364

Enrollment

Registered

2016-10-21

Start date

2011-07-01

Completion date

Unknown

Last updated

2020-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic brain injury in the subacute and chronic phase of recovery, with deficits in social cognition Nervous System Diseases Traumatic brain injury in the subacute and chronic phase of recovery, with deficits in social cognition

Interventions

Participants who have given consent to participate are randomly assigned to the experimental condition (Treatment of Social Cognition and Emotion Regulation: T-ScEmo) or the control condition (a train

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Moderate to severe traumatic brain injury 2. Sub-acute or chronic stage of recovery 3. Referred on clinical grounds, that is, being identified as having changes in social functioning, with at least 1 deficit in social cognition tests and/or proxy ratings on the BAFQ-social monitoring and/or empathy scale>10 4. Orbitofrontal/medioprefrontal brain damage demonstrated with MRI 5. Presence of a proxy to fill in questionnaires

Exclusion criteria

Exclusion criteria: 1. Neurodegenerative or psychiatric illness 2. Severe cognitive impairment that would preclude treatment (i.e. amnestic syndrome, global aphasia, neglect) 3. Very severe behavioral regulation deficits for which continuous external control was needed and/or physical aggressiveness 4. Severe depression

Design outcomes

Primary

Measure	Time frame
Improvement of social cognition (pre- to postmeasurement) on the Awareness of Social Inferences Test (TASIT-short) at baseline, within 2 weeks of the last treatment session and at 3-5 monts follow up.	—

Secondary

Measure	Time frame
1. Facial affect recognition is measured using the Facial Expression of Emotional Stimuli Test (FEEST) at baseline, within 2 weeks of the last treatment session and at 3-5 monts follow up 2. Theory of Mind is measured using the Cartoon Test and Faux Pas test, at baseline, within 2 weeks of the last treatment session and at 3-5 monts follow up 3. Behavioural functioning is measured (participant and significant other ratings) using subscales of the Brock Adaptive Functioning Questionnaire (BAFQ) and the Dysexecutive Questionnaire (DEX) at baseline, within 2 weeks of the last treatment session and at 3-5 monts follow up 4. Treatment goal attainment is measured using the Treatment Goal Attainment (TGA) scale at baseline, within 2 weeks of the last treatment session and at 3-5 monts follow up 5. Participation is measured using the Role Resumption List at baseline, within 2 weeks of the last treatment session and at 3-5 monts follow up 6. Quality of Life is measured using the QOLIBRI at baseline, within 2 weeks of the last treatment session and at 3-5 monts follow up 7. Quality of the relationship is measured using the Relation-Score at baseline, within 2 weeks of the last treatment session and at 3-5 monts follow up 8. Treatment satisfaction is measured using the Treatment Satisfaction Scale (TSS), within 2 weeks of the last treatment session and at 3-5 monts follow up	—

Measure

Time frame

1. Facial affect recognition is measured using the Facial Expression of Emotional Stimuli Test (FEEST) at baseline, within 2 weeks of the last treatment session and at 3-5 monts follow up 2. Theory of Mind is measured using the Cartoon Test and Faux Pas test, at baseline, within 2 weeks of the last treatment session and at 3-5 monts follow up 3. Behavioural functioning is measured (participant and significant other ratings) using subscales of the Brock Adaptive Functioning Questionnaire (BAFQ) and the Dysexecutive Questionnaire (DEX) at baseline, within 2 weeks of the last treatment session and at 3-5 monts follow up 4. Treatment goal attainment is measured using the Treatment Goal Attainment (TGA) scale at baseline, within 2 weeks of the last treatment session and at 3-5 monts follow up 5. Participation is measured using the Role Resumption List at baseline, within 2 weeks of the last treatment session and at 3-5 monts follow up 6. Quality of Life is measured using the QOLIBRI at baseline, within 2 weeks of the last treatment session and at 3-5 monts follow up 7. Quality of the relationship is measured using the Relation-Score at baseline, within 2 weeks of the last treatment session and at 3-5 monts follow up 8. Treatment satisfaction is measured using the Treatment Satisfaction Scale (TSS), within 2 weeks of the last treatment session and at 3-5 monts follow up

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Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026