Our main objective is to investigate whether an augmented CBT leads to the reduction of depression and anxiety symptoms in stroke patients. We will compare the outcomes of this experimental treatment with a control intervention (i.e., computerized…
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
- Vascular haemorrhagic disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter will be the HADS
Secondary outcome
Secondary parameters will be cost effectiveness, participation, quality of
life, goal attainment, and rehabilitation/treatment participation.
Background summary
Not only does stroke cause physical disability, it also has severe emotional
consequences (e.g., anxiety and depression symptoms). Depression is a commonly
reported neuropsychiatric complication of stroke. Most studies on treatment of
Post Stroke Depression (PSD) have focused on medical interventions (e.g.,
antidepressants). In studies on treatment effects in depression Cognitive
Behavioural Therapy (CBT) has been shown to decrease depressive symptoms and
improve quality of life. Since there is a lack of research studying
psychological interventions in PSD, and positive CBT treatment effects have
been found in a pilot study, we will perform a randomised controlled trial on
the treatment effects of an augmented CBT intervention in patients with post
stroke depression and anxiety (PSDA). We expect this treatment to decrease
patients* depression and anxiety symptoms and to increase the level of social
activities and life satisfaction. In addition, the cost effectiveness of the
intervention will be studied from a societal perspective.
Study objective
Our main objective is to investigate whether an augmented CBT leads to the
reduction of depression and anxiety symptoms in stroke patients. We will
compare the outcomes of this experimental treatment with a control intervention
(i.e., computerized cognitive training) in which the elements that are
hypothesized to be essential and effective in the augmented CBT intervention
will not be offered. A secondary objective is to determine the costs of both
interventions in relation to the outcomes. Furthermore, we will investigate
whether the experimental treatment will lead to higher levels of social
activities, attainment of individual goals, life satisfaction and quality of
life, compared to control treatment.
Study design
The present study will be a double blind randomised controlled trial. Post
stroke patients and their significant others will be assessed at T0,
pre-treatment; T1, post treatment; T2, 6 months post treatment; and T3, 12
months post treatment.
Intervention
The intervention consists of augmented cognitive behavioural therapy. CBT
treatment will focus on registering, challenging and altering of negative
thoughts, concomitant mood states, , cognitions and emotional symptoms, which
comprise depression as well as anxiety. The CBT intervention is an individually
administered psychological therapy. Treatment sessions will be given within a
time span of 4 months (minimum 13, maximum of 16 sessions)
Study burden and risks
Subjects will have to meet their rehabilitation specialist (e.g., psychologist)
for regular CBT treatment sessions, augmented with additional occupational or
movement therapy. Next to that, they will have to keep up their homework in a
workbook and possibly make use of a diary. There will be four measurements
where subjects have to fill in multiple questionnaires, significant others will
be assessed at the same moments in time, yet with a shortened set of
questionnaires.
reinier postlaan 2, postbus 9101
6500 HB Nijmegen
NL
reinier postlaan 2, postbus 9101
6500 HB Nijmegen
NL
Listed location countries
Age
Inclusion criteria
Subjects have suffered from symptomatic stroke (ischaemic, subarachnoid or intracerebral
haemorrhagic lesion), first or recurrent, verified by CT and/or MRI scan.
- Subjects experience depression and/or anxiety symptoms, according to scores >=7 on the depression subscale of the Hospital Anxiety and Depression Scale (HADS).
- Subjects are >3 months post stroke.
- Subjects are at least 18 years of age or older.
- Subjects have sufficient communication and cognitive skills to engage in treatment (MMSE and NIHSS-item).
- Written informed consent.
- Subjects have sufficient knowledge of the Dutch language to speak and understand in Dutch. ;Significant Others
- Significant others are able to read and write in Dutch.
- Significant others are >18 years of age.
Exclusion criteria
Subjects* pre-existing impairment or history that might influence cognitive or functional outcome (pre-existent dependence in activities of daily living as defined by an estimated pre-morbid Barthel Index of 18).
- subjects staying in inpatient settings.
- subjects* co-morbidity that might affect outcome like cancer or psychiatric illnesses for which treatment is given at the moment of inclusion in the study, pre-existent cognitive decline as defined by a s score of 3.6 or higher on the IQCODE.
- Major Depression diagnosis in subjects that requires medication therapy
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL35333.091.11 |
| OMON | NL-OMON21664 |