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

Recruiting

• Conditions: post stroke depression and anxiety. emotional complaints after stroke; 10027946; 10047075

• Registration Number: NL-OMON36300
• Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 106

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter will be the HADS</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary parameters will be cost effectiveness, participation, quality of<br /><br>life, goal attainment, and rehabilitation/treatment participation. </p><br>