Main: To demonstrate the effectiveness of the T-ScEmo treatment for social cognition impairments in neurological patient groups other than TBI (i.e. patients with stroke, subarachnoidal haemorrhage (SAH), brain tumors, multiple sclerosis, cerebral…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Neurologische aandoening, waaronder cva, ms, hersentumoren
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the difference between T2 (long-term follow-up) and
T0 of the score on the Dutch version of the Dysexecutive Questionnaire- Social
scales proxy version (DEX-Socproxy; Spikman et al., 2013; Westerhof-Evers,
2017). This is a measure for informant rated social competent behavior. The
difference between T2 and T0 should be significantly larger than the
difference in the control group to control for test-retest effects. T2 is
chosen because we deem it relevant to establish that treatment effects last
over time, that is, are still present at follow-up measurement.
Secondary outcome
Secondary endpoints will be improvements on tests for social cognition,
questionnaires for social abilities, social participation, quality of life
(QoL), mood, relationship quality, goal attainment scaling (GAS), between T0
and T1, and T0 and T2 respectively.
Background summary
Social cognition involves the abilities to perceive social information,
understand others and respond appropriately, which are underlied by
frontal-subcortical brain circuits. Impairments in social cognition are
trans-diagnostic: they can be found in various neurological disorders in which
these circuits can be affected, such as traumatic brain injury (TBI), stroke,
brain tumors and multiple sclerosis. Given the detrimental consequences of
impaired social cognition for quality of life and participation of patients,
effective treatments are sorely needed. Previously, a treatment for these
impairments, called T-ScEmo (Treatment of Social cognition and emotion) was
developed at our department and found to be effective in improving social
cognition and social behaviour in patients with traumatic brain injury (TBI).
For other neurological patient groups with similar problems, who are eligible
for rehabilitation treatment, effectiveness still has to be demonstrated, which
is the purpose of the present study.
Study objective
Main: To demonstrate the effectiveness of the T-ScEmo treatment for social
cognition impairments in neurological patient groups other than TBI (i.e.
patients with stroke, subarachnoidal haemorrhage (SAH), brain tumors, multiple
sclerosis, cerebral infections) that are eligible for (neuropsychological)
rehabilitation treatment. Secondary objective: to determine which patient
related factors are of influence on treatment effectiveness.
Study design
A multi-center single blind randomized controlled trial (RCT) in patients with
neurological disorders, in a longitudinal repeated measures design
(measurements at pre-treatment (T0), post-treatment (T1) and long term follow
up (T2)).
Intervention
A neuropsychological rehabilitation treatment (T-ScEmo: treatment of social
cognition and emotion) involving training of social information processing and
teaching strategies for social cognition and social behavior, consisting of 15
1 hr. *in vivo* sessions (1 or 2 times a week) and 5 e-learn practice sessions.
Close others/partners will be involved in a part of the sessions. Control
condition: waiting list, to control for test-retest effects.
Study burden and risks
The treatment has no adverse consequences for patients and close-others, and
involves no risks. The burden is low and mainly mental, that is, the treatment
requires sufficient effort and motivation of patients, to visit the treatment
center, follow sessions and perform home-assignments. As it is given by
experienced psychologists, these will carefully monitor patients* energetic
status and well being. It is likely that patients in the treatment condition
will experience benefits of the treatment. Our experience with the previous
T-ScEmo study in patients with TBI was that all patients were able to complete
the treatment without negative effects, and the majority reported to have
benefitted. For patients in the control condition, the burden is that they will
undergo three measurements at similar intervals as the treatment group; the
burden of these assessments is low. Moreover, these patients will be offered to
receive the treatment in case the study shows that it is effective, which may
also be a benefit from participating in the study.
Hanzeplein 1
Groningen 9700RB
NL
Hanzeplein 1
Groningen 9700RB
NL
Listed location countries
Age
Inclusion criteria
Patients should have a neurological disorder (see above); Age between 18 and
75; As prospects may be different for individual patients, patients should be
in the chronic stage (> 6 months post acute injuries) or their medical
condition should be relatively stable (for those with a slow progressive
condition), to be judged by the treating medical or psychological specialist,
in order to be able to profit from treatment for a reasonable time period.
Also, the presence of a close other is an inclusion criterion
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
- Serious neurodegenerative or psychiatric conditions (including addiction)
interfering with treatment
- Incapacity to act, to be judged by the neuropsychologist and/or neurologist.
- Serious cognitive problems (aphasia, neglect, amnesia, dementia) and/or
serious behavioral problems (aggression, apathy) interfering with treatment, to
be judged by neuropsychologist.
- Serious (other) medical conditions or physical inability hindering patients
to come to the hospital/rehabilitation center,
- Not being available of a close other (life partner, family member, close
friend) who can fill out the proxy questionnaires
- Not willing to give permission to send important/unexpected findings to the
general practitioner.
- In addition: unexpected progression of disease during the study can be a
reason to exclude the patient.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL75825.042.20 |