Cognitive rehabilitation treatment of deficits in emotion, social cognition and regulation of behaviour after traumatic brain injury; evaluation of effect using a randomized controlled trial (RCT)

Cognitive rehabilitation treatment of deficits in emotion, social cognition and regulation of behaviour after traumatic brain injury; evaluation of effect using a randomized controlled trial (RCT) - Treatment of Social Cognition in TBI patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON38197

Enrollment

Registered

2011-07-06

Start date

2011-07-14

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

traumatisch hersenletsel

Interventions

A cognitive rehabilitation treatment of deficits in social cognition, or a training of attention, given by an experienced neuropsychologist, twice a week, 20 sessions of 1 hour each.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1) Deficient score on the Brock Adaptive Functioning Questionnaire (BAFQ, Dywan & Segalowitz, 1996) 2) Deficient score on the Facial Expression of Emotion Test (FEEST, Young, 2003) AND/OR 3) orbitofrontal/mediofrontal damage on MRI

Exclusion criteria

Exclusion criteria: Neurodegenerative or psychiatric disorders, lack of self-awareness, severe cognitive comorbidity interfering the ability to follow a treatment (global aphasia, neglect, amnestic symdrome), there is no proxy who can fill in the questionnaires. See page 15 and 16 of the protocol

Design outcomes

Primary

Measure	Time frame
Inprovement of social cognition, that is, a significant improvement pre- to postmeasurement on the Awareness of Social Inference Test (TASIT, Mc Donald et al., 2003).	—

Secondary

Measure	Time frame
Questionnaires and checklist for social functioning in daily life (patient): * Balanced Emotional Empathy Scale (BEES, Mehrabian,2000), * Berkeley Expressivity Questionnaire (BEQ, Gross & John, 1997), * Brock Adaptive Functioning Questionnaire (BAFQ, Dywan & Segalowitz, 1996), * Dysexecutive Questionnaire (DEX, Wilson, e.a., 1996), * Quality of Life after Brain Injury (QOLIBRI, Von Steinbuchel e.a., 2005), * Self Efficacy for Symptom Management (SEsx, Cicerone, 2008), * Treatment Goal Attainment (TGA, Spikman et al. 2010), * Utrechtse Copinglijst (UCL, Schreurs & van de Willige, 1988). Questionnaires and checklist for social functioning in daily life (psychologist, psychological assistant, proxy): * Brock Adaptive Functioning Questionnaire (BAFQ, Dywan & Segalowitz, 1996), * Dysexecutive Questionnaire (DEX, Wilson, e.a., 1996), * Rolhervattingslijst (RLL, Spikman et al., 2010), * Proxy questionnaire (developed for this study, 2011). Tests voor social cognition * Facial Expression of Emotional Stimuli Test (FEEST (Young e.a., 2002), * Cartoon Test (Happé e.a. 1999), * Faux Pas test (Stone e.a., 1998), * Iowa Gambling Task (IGT, Bechara e.a., 1994). Cognitive functions: * Premorbid IQ (Nederlandse Leestest voor Volwassenen, NLV, Schmand e.a., 1992). * Executive functioning (Zoomap, Behavioural Assessment of the Dysexecutive Syndrome (BADS, Wilson et al, 1996)), * Memory -15 woordentest (15 woordentest, Deelman, Brouwer, van Zomeren en Saan, 1980) - WAIS Digit Span (WAIS Digit Span, Wechsler Adult Intelligence Scale-III, Wechsler, 1997) * Attention: -Test of Everyday Attention (TEA, Robertson et al, 1994) -Stroop Kleur Woord test (Stroop, 1935) -Trailmaking test (TMT, Reitan, 1958)	—

Measure

Time frame

Questionnaires and checklist for social functioning in daily life (patient): * Balanced Emotional Empathy Scale (BEES, Mehrabian,2000), * Berkeley Expressivity Questionnaire (BEQ, Gross & John, 1997), * Brock Adaptive Functioning Questionnaire (BAFQ, Dywan & Segalowitz, 1996), * Dysexecutive Questionnaire (DEX, Wilson, e.a., 1996), * Quality of Life after Brain Injury (QOLIBRI, Von Steinbuchel e.a., 2005), * Self Efficacy for Symptom Management (SEsx, Cicerone, 2008), * Treatment Goal Attainment (TGA, Spikman et al. 2010), * Utrechtse Copinglijst (UCL, Schreurs & van de Willige, 1988). Questionnaires and checklist for social functioning in daily life (psychologist, psychological assistant, proxy): * Brock Adaptive Functioning Questionnaire (BAFQ, Dywan & Segalowitz, 1996), * Dysexecutive Questionnaire (DEX, Wilson, e.a., 1996), * Rolhervattingslijst (RLL, Spikman et al., 2010), * Proxy questionnaire (developed for this study, 2011). Tests voor social cognition * Facial Expression of Emotional Stimuli Test (FEEST (Young e.a., 2002), * Cartoon Test (Happé e.a. 1999), * Faux Pas test (Stone e.a., 1998), * Iowa Gambling Task (IGT, Bechara e.a., 1994). Cognitive functions: * Premorbid IQ (Nederlandse Leestest voor Volwassenen, NLV, Schmand e.a., 1992). * Executive functioning (Zoomap, Behavioural Assessment of the Dysexecutive Syndrome (BADS, Wilson et al, 1996)), * Memory -15 woordentest (15 woordentest, Deelman, Brouwer, van Zomeren en Saan, 1980) - WAIS Digit Span (WAIS Digit Span, Wechsler Adult Intelligence Scale-III, Wechsler, 1997) * Attention: -Test of Everyday Attention (TEA, Robertson et al, 1994) -Stroop Kleur Woord test (Stroop, 1935) -Trailmaking test (TMT, Reitan, 1958)

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)