This study focuses on the the effect of treatment (12 weeks/sessions) on cognitive functioning. Therapy for cognitive functioning exists (regular treatment protocol at the participating clinic) of cognitive behavioral therapy (CBT) and cognitive…
ID
Source
Brief title
Condition
- Somatic symptom and related disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome of this study is subjective cognitive functioning as
measured by the Cognitive Faillure Questionnaire (CFQ) (Broadbent,Cooper,
FitzGerald & Parkes, 1982). The CFQ is a self-report questionnaire related to
everyday cognitive failure/misstakes related to cognitive functioning. The
questionnaire consists of 25 items which are measured using a 5-point scale (0
= never, 4=always). The CFQ has good psychometric properties, include
test-retest reliability (Ponds, van Boxtel & Jolles, 2006) and reliability
(Bridger, Johnsen& Brasher, 2013). Higher scores are indicative for more
subjective congitive symptoms. The CFQ-scores are measured before, during (6
weeks) and after treamtnt to evaluate the course of cognitive functioning
during therapy.
Secondary outcome
Neuropsychological assesment (NPA) is conducted twice. Firstly, NPA is
conducted to provide a framework for the therapy sessions. The second NPA is
conducted to evaluate objective cognitive functioning after therapy. This NPA
takes approximately 30 minutes and is considered an (minimal) extra effort for
patients. NPA is used to assess the different cognitive domains (e.g., memory,
attention, executive functioning).
Scores will be transformed into classificantion 'no cognitive disorders' (equal
to or larger that 20th percentile), 'impaired cognitive functioning' (between
2nd and 20th percentile), and 'cognitive disorder' (smaller than 2nd
percentile) based upon the criteria from Lezak, Howiesan, & Loring (2012). The
following tests will be conducted: the digit span and symbol substitution from
the Wechsler Adult Intelligence Scale (WAIS-IV-NL; Wechsler, 2012) is used to
assess working memory and information processing speed, respectively. The Tower
test of the DKEFS (Delis et al, 2001) is used to assess planning (Executive
functioning), and the rey auditory verbal learning test (15WT; Kalverboer &
Deelman, 1986) is used to assess verbal memory processes. The rey osterrieth
complex figure test is used to assess visual memory (Osterrieth, 1944) and the
d2 is used to assess attention (Brickenkamp, 2002). The psychometric properties
of these tests are sufficient and can be found in the manuals (Brickenkamp,
2002;'Delis et al., 2001; Kalverboer & Deelman, 1986; Wechsler, 2012).
Note: to control for possible learning effect, during the second NPA the
b-version of the RAVLT will be conducted. The learning effect of the other
tests are considered minimal
Background summary
Somatic symptom and related disorder (SSRD) often coincides with impaired
cognitive functioning but has received little attention untill recently.Other
studies in the field of depression and anxiety already suggested impaired
cognitive functioning. These disorder are often seen comorbidly with SSRD.
Regular treatment of SSRD is primarily offered in the form of cognitive
behavioral therapy (CBT) but often lacks efficivity. Several case descriptions
suggest that cognitive rehabilitation therapy (CRT) can improve cognitive
functioning which in turn may improve the effectivity of CBT (because treatment
sessions can, for instance, be remembered better). Whether the combination of
CRT before CBT may improve treatment effectivity in patients with SSRD is
worthwhile exploring in the future but before such studies can be conducted we
first have to explore the effect of CRT on cognitive functioning in patients
with SSRD.
Study objective
This study focuses on the the effect of treatment (12 weeks/sessions) on
cognitive functioning. Therapy for cognitive functioning exists (regular
treatment protocol at the participating clinic) of cognitive behavioral therapy
(CBT) and cognitive rehabilitation therapy (CRT). Subjective cognitive
functioning is compared between the two therapies before and after therapy. The
secundairy outcome measure includes an objective measure of cognitive
functioning. To explore the effect on objective cognitive functioning, the
results of a neuropsychological assessment before treatment (standard protocol
to provide an aim for the therapy) and after treatment will be compared.
Study design
This study follows a 2x3 mixed model randomized design with cognitive
rehabilitation therapy (CRT) vs. standard of care cognitive behavioral therapy
(CBT) as between-subjects factor and repeated measures of the outcome measures
(pre-intervention, 6 weeks, and 12 weeks = end intervention) as within-subjects
factor. A questionnaire used to asses subjective cognitive functioning is used
for the repeated measures variable. The study will take place from 1st of
january 2021 until 1st of september 2021 at the clinic of excellence for body
mind and health, GGz Breburg. At this clinic, CRT is offered in the standard
care based on studies regarding its effecitivity in patients with acquired
brain injuries. Cognitive symptoms are also treated using CBT at this clinic
(primarily due to the lack of trained psychologists in CRT) while focussing on
dysfunctional thoughts regarding these symptoms (in short). The
neuropsychological assessment (NPA) is part of (standard) clinical practice
since the NPA and CFQ are used to select the kind of intervention (standard CBT
or CRT) that is offered (focusing on specific cognitive domains).The additional
burden related to this scientific study is considered minimal and primarily
involves completion of study-related questionnaires (approximately 5 minutes
per assessment and an end-intervention neuropsychological assessment (30
minutes); total 40 minutes).
Intervention
Cognitive rehbailitation therapy (CRT) aims to learn a compensatory strategy to
overcome cognitive symptoms in a broad range of cognitive domains. For
instance, the protocol for impaired mental speed (Winkens & Fasotti, 2010)
offers a strategy to overcome impairments within the domain of information
processing speed. This protocol contains three stages. The first stage focuses
primarily on increasing awareness of the deficits and the relationship between
mental slowness and perceived problems in daily life. In the second stage, the
main focus is on acceptance and acquisition of the strategy. Besides relating
the (poor) performance of the patient and the concept of time pressure, the
strategy will be explained and taught to the patient. The final stage focuses
on strategy application and maintenance. This stage mainly involves real-life
application of the strategy by the patient, evaluating the results of its
application and improving the strategy during the treatment session. Other
protocols target improving executive functioning and memory but we expect to
use the protocol for mental speed based on our prior findings that information
processing speed is most frequently impaired in patients with SSRD (De Vroege
et al., 2018).
Cognitive behavioral therapy (CBT)
CBT centers on identifying and changing or modifying inaccurate or distorted
thoughts concerning ones symptoms. These symptoms may be psychiatric, for
instance depression, for which a depression CBT protocol is available. During
CBT in the control condition, automatic negative thoughts regarding cognitive
failures or cognitive symptoms will be identified, challenged and replaced with
objective, realistic thoughts. In this way, CBT contributes to feeling less
stressed about cognitive failures or symptoms and improves patients* wellbeing.
Due to the fact that no other therapy focuses on cognitive symptoms, CBT is
regularly used in therapy at CLGG for targeting these negative thoughts
regarding cognitive failures/symptoms.
Study burden and risks
Patients are treated with care as usual. Baseline assessments with NPA and CFQ
are part of (standard) clinical practice since the NPA and CFQ are used to
select the kind of intervention (standard CBT or CRT) that is offered (focusing
on specific cognitive domains).The additional burden related to this scientific
study is considered minimal and primarily involves completion of study-related
questionnaires (approximately 5 minutes per assessment and an end-intervention
neuropsychological assessment (30 minutes); total 40 minutes). Participants can
leave the study at any time for any reason if they wish to do so without any
consequences. Furthermore, if patients do not wish to participate in this
study, data gathered during intake will not be used for this purpose and their
treatment trajectory continues as per usual. Withdrawal has no consequences for
treatment selection at CLGG.Patients whom are offered CBT and for which
cognitive symptoms remain after treatment, CRT is offered as well.
Psychologists at the clinic are trained in CRT and supervision during treatment
is provided (already provided, not specifically set up for this study),
Benefits for the patients contain the insights we would like to obtain with
regards to treatment of cognitive symptoms in patients with SSRD, which is
frequently reported but not treated for.
Lage Witsiebaan 4
Tilburg 5042 DA
NL
Lage Witsiebaan 4
Tilburg 5042 DA
NL
Listed location countries
Age
Inclusion criteria
patients with SSRD, >= 18 years, cognitive symptoms.
Exclusion criteria
Exclusion criteria: direct risk of suicide, dementia, usage of illicit drugs
within the past 6 months, consumption of more than 21 units of alcohol per
week, illiteracy, insufficient knowledge of Dutch language or short-term risk
of psychoses, and refusal to informed consent .
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 | NL75852.028.20 |