The goal of this pilot study is to (i) investigate which measurements are suitable best for the evaluation of (cost) effectiveness, (ii) investigate whether CAT can be given as a nursing intervention (feasability).
ID
Source
Brief title
Condition
- Schizophrenia and other psychotic disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Prior to the baseline-assessment (T0), patients will be asked to participate in
CAT. Effect measurements will be carried out after 4 months (T4) and after 8
months (T8).
It is still unknown which outcome measurements will adress the research
questions (mentioned under Objectives) best. Therefore, multiple outcome
measures will be included in this study. In a recent study by Velligan et al.
(2008), an effect size of Cohen's D > 1.0 was reported. Therefore, we expect
the GAF-D to be most sensitive for change in daily functining. Furthermore, the
Multnomah Community Ability Scale (MCAS) and the Negative Symptoms Assessment
(NSA) will be assessed. These semi-structured interviews are also used in the
American CAT-studies. The MCAS contains 17 items on domains interfering with
functioning, independence & acceptation, social competence and behavioral
problems. From the NSA, only the subscale motivation will be assessed, which
contains items on self care, activities and sense of purpose.
To adress the second research question (feasability of CAT as a nursing
intervention), the Quality Assurance Measures Form (QAMF) and the Client
Satisfaction Questionnaire (CSQ) will be assessed. The QAMF is a treatment
fidelity form, also used in the studies by Velligan et al., and is being scored
from supervision sessions and tape recordings of the CAT-session. The patient
will be assessed with an amended version of the CSQ, to evaluate client
satisfaction.
Furthermore, we expect empowerment to be an important outcome measure. The
Mental Health Confidence Scale (MHCS) will be used to adress this, for this
scale has proven to be sensitive for change (Castelein et al., 2008).
An overview of all outcome measurements used in this study can be found below,
and under 'secondary study parameters'.
Effect measures (T0, T4 en T8)
Total duration: 1* hours
Daily functioning:
1. Global Assessment of Functioning - Disabilities (American Psychiatric
Association, 1994), scored by external rater
Secondary outcome
Daily functioning:
2. Multnomah Community Ability Scale (Barker), semi-gestructureerd interview
3. Negative Symptom Assessment, subscale motivation (Alphs), semi-structured
interview
4. Social Functioning Scale (Birchwood et al., 1990), self-report and proxy
5. Goal Attainment Scale (Steinbook et al., 1977), semi-structured interview
Well being:
1. Mental Health Confidence Scale (Carpinello et al., 2000), self-report
2. Manchester Short Assessment of Quality of Life (Priebe et al., 1999),
self-report
3. EuroQoL - 5D (König et al., 2007), self-report
Performance based tasks:
1. Mini Mental State Examination (Roper et al., 1996)
2. Frontal Assessment Battery (Dubois et al., 2000)
3. Test of Adaptive Behavior for Schizophrenia, subtest Self-Medication
(Velligan et al., 2007)
Treatment evaluation:
1. Quality Assurance Measures Form (Velligan, unpublished)
2. Client Satisfaction Questionnaire (CAT-version) (de Brey, 1983)
Background summary
The prevalence of schizophrenia is at least 0.6%. In the Netherlands, there are
at least 100.000 people who have got a diagnosis schizophrenia during their
life. Fifteen percent of this population are characterized by good remission
with full recovery. In 65%, the course is variable, often accompanied with long
lasting care dependence. The other 20% have a course that is chonically
psychotic, whether or not in combination with institutional dependence.
Schizophrenia is associated with a high suïcide risk.
Partial recovery and care dependency in schizophrenia often lead to social
disfunctions. To assist patients in this process, an intervention is needed
that leads to more activities, less social isolation and maximum degree of
social participation.
A fundamental problem in schizophrenia is the cognitive impairment, which is a
better predictor of functional outcome, compared to positive symptoms. In
schizophrenia, cognitive impairment can be regarded the core of the disorder.
Unfortunately, the Dutch care for individuals with schizophrenia has no
intervention which bridges the gap between neuropsychology and everyday living.
Therefore, studies are needed in which treatment programs are being evaluated
that have proven their efficacy elsewhere.
Cognitive Adaptation Training (CAT, developed by prof dr Dawn Velligan in 1996)
is a series of manual-driven compensatory strategies and environmental supports
designed to diminish the negative consequenses cognitive dysfunctions have on
daily functioning. CAT particularly bypasses impairments in executive abilities
(planning and goal directed behavior). In the United States, CAT leads to
improvements on daily functioning, quality of life, motivation and medication
adherence. Treatment plans for CAT can be targeted at multiple areas of daily
functioning, such as self care, household tasks, mobility, leisure activities
and social network. This makes the training program suitable for patients in
residential care (APZ/RIBW), as well as outpatients (BZW/poliklinisch).
Study objective
The goal of this pilot study is to (i) investigate which measurements are
suitable best for the evaluation of (cost) effectiveness, (ii) investigate
whether CAT can be given as a nursing intervention (feasability).
Study design
A non-randomized pilot study with blind rating (planned analysis: Repeated
Measures ANOVA).
The study concerns a pilot, in which only patients will be included that
receive either CAT or TAU. Prior to the study, potential candidates will be
approached with the question whether they agree with being assessed with a
number of questionnaires about daily functioning and related matters. When the
candidate meets the inclusion criteria, he/she will get information about CAT,
and will be asked to participate. Participants in TAU will get the opportunity
to participate in a future CAT study. Informed consent will be obtained after
2 weeks.
During CAT, patients are seen weekly during sessions of 45 minutes, in their
home environment (or their own living room in the residential facility), for 8
months. During the end of the program, sessions can be given once in 2 weeks.
Intervention
Treatment plans that include cognitive adaptation training are based on two
dimensions: 1) the patient*s level of apathy versus disinhibition, and 2) the
patient*s level of impairment in executive functions. Behaviors characterized
by apathy can be altered by providing prompting and cueing that help the
patient initiate each step in a sequenced task. Individuals who exhibit
disinhibited behavior respond well to the removal of distracting stimuli and
behavioral triggers and to redirection. Individuals with mixed behavior (both
apathy and disinhibition) are offered a combination of these strategies.
Individuals with greater degrees of executive impairment are provided a greater
level of structure and assistance and more obvious environmental cues (larger,
more brightly colored, and more proximally placed cues). Individuals with less
impairment in executive function can perform instrumental skills adequately
with less structure and more subtle cues.
These general plans are adapted for individual strengths or limitations in
verbal/visual attention, memory, and fine motor coordination. Interventions are
explained and maintained or altered as necessary by means of brief weekly
visits from a cognitive adaptation training therapist. From the clinical
experience of CAT-therapists it can be suggested that patients enjoy the
contact with the therapist, appreciate the environmental supports, and look
forward to each visit. Because CAT also has a positive effect on motivation and
quality of life, we expect the burden of this intervention on the patient to be
low. Environmental supports that will be used in the study will be calenders,
watches, agenda's, electronic devices, signs, household utensils and supports
for mobility and leasure activities.
Study burden and risks
There are a number of reasons to assume that burden on the patient is low:
- the patient is seen on a weekly basis in the home environment, and does not
need to visit the institution
- the training is individually tailored. The pace of the training program and
area's of focus are defined by the results of the baseline assessment and in
collaboration with the patient
- the patient is not only provided with environmental supports, these are also
introduced and evaluated/adjusted during the training.
- patients in the control condition will be informed that they will receive
CAT, but that this will be in the future, when funds are available.
Hanzeplein 1
9700 RB Groningen
NL
Hanzeplein 1
9700 RB Groningen
NL
Listed location countries
Age
Inclusion criteria
Schizophrenia or schizo-affective disorder according to DSM-IV criteria, age between 21 and 65 years old, fluent in Dutch, cognitive impairment, problems in daily functioning (GAF-D < 60), being to receive CAT on a weekly basis (one session of 45 minutes every week)
Exclusion criteria
Premorbid IQ < 75, cognitive impairment due to neurological disorder, agressive behavior, alcohol- or substance dependency within 6 months prior to inclusion.
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 | NL27675.042.09 |