The treatment of anxiety and depressive symptoms after acquired brain injury.
- Conditions
- <p>Acquired brain injury (ABI), Anxiety, Depression Niet aangeboren hersenletsel (NAH), Angst, Depressie</p>
- Registration Number
- NL-OMON23617
- Lead Sponsor
- Maastricht University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 94
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- having sustained any type of stroke or traumatic brain injury which is objectified by a neurologist;
- the depression subscale of the Hospital Anxiety and Depression Scale (HADS) is above 7 and/or the anxiety subscale of the HADS is above 7;
- being 18 years or older;
- stable use of medication (such as antidepressants) for the duration of the study and use of antidepressants should be stable four weeks prior to the beginning of the study;
- access to the internet and a computer because treatment materials such as patient videos are shown via the internet;
- the Dutch language, cognitive and communicative skills are sufficient to benefit from treatment based on clinical judgement; and
- giving informed consent.
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- history of brain injury or disease (objectified by neurologist and classified as moderate or severe) or any neurological disorder (such as: idiopathic epilepsy, brain tumor, meningioma, multiple sclerosis, Huntington’s disease, Parkinson’s disease, meningitis, or encephalitis) other than a stroke and traumatic brain injury;
- pre-morbid disability as assessed with the Barthel Index (score<19/20);
- severe co-morbidity that might affect outcome (e.g., cancer or major psychiatric illnesses for which treatment is given at the moment of inclusion);
- ongoing mood and/or anxiety disorder based on the DSM 5 for which pharmacological and/or psychological treatment was necessary during the onset of the brain injury;
- attendance in a previous ACT intervention for comparable problems in the year proceeding entry in the current study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary outcome measure for clinical effectiveness is the Hospital Anxiety and Depression Scale (HADS) measuring depressive and anxiety symptoms. Primary outcome measure for the cost effectiveness will be the five-dimensional five-level EuroQol (EQ-5D-5L) and a cost-questionnaire specifically designed for this study.</p>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcome measures are the Depression Anxiety Stress Scale (DASS-21), Utrecht Scale for Evaluation of Rehabilitation-Participation (USER-P), Short Form Survey (SF12), Acceptance and Action Questionnaire II (AAQ-II), Acceptance and Action Questionnaire after brain injury (AAQ-ABI), Valued Living Questionnaire (VLQ) and the Cognitive Fusion Questionnaire (CFQ-7).</p>