Clinical and cost-effectiveness of Acceptance and Commitment Therapy for depression and anxiety after acquired brain injury

Completed

Conditions: Hersenletsel patiënten met angst en/of depressie klachten
'brain dammage' en 'acquired brain injury (ABI)'

Registration Number: NL-OMON50203

Lead Sponsor: niversiteit Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 94

Inclusion Criteria

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
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.

Exclusion Criteria

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<br /><br>Depression Scale (HADS) measuring anxiety and depressive symptoms and the<br /><br>Depression Anxiety Stress Scale (DASS-21) measuring depression, anxiety and<br /><br>stress. Primary outcome measure for the cost effectiveness will be the<br /><br>five-dimensional five-level EuroQol (EQ-5D-5L) and a cost-questionnaire<br /><br>specifically designed for this study. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome measures are the Utrecht Scale for Evaluation of<br /><br>Rehabilitation-Participation (USER-P), Short Form Survey (SF12), Acceptance and<br /><br>Action Questionnaire II (AAQ-II), Acceptance and Action Questionnaire after<br /><br>brain injury (AAQ-ABI), Valued Living Questionnaire (VLQ) and the Cognitive<br /><br>Fusion Questionnaire (CFQ-7).</p><br>