Cost effectiveness of augmented cognitive behavioural therapy for post stroke depression and anxiety

Cost effectiveness of augmented cognitive behavioural therapy for post stroke depression and anxiety - Restore - CBT study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON36300

Enrollment

106

Registered

2011-06-01

Start date

2011-12-01

Completion date

Unknown

Last updated

2024-06-11

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

Conditions

post stroke depression and anxiety. emotional complaints after stroke

Interventions

The intervention consists of augmented cognitive behavioural therapy. CBT treatment will focus on registering, challenging and altering of negative thoughts, concomitant mood states, , cognitions an

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
The main study parameter will be the HADS	—

Secondary

Measure	Time frame
Secondary parameters will be cost effectiveness, participation, quality of life, goal attainment, and rehabilitation/treatment participation.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)