Examining the clinical and cost-effectiveness of ACT for individuals with ABI who experience depressive and/or anxiety symptoms.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Hersenletsel patiënten met angst en/of depressie klachten
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measure for clinical effectiveness is the Hospital Anxiety and
Depression Scale (HADS) measuring anxiety and depressive symptoms and the
Depression Anxiety Stress Scale (DASS-21) measuring depression, anxiety and
stress. 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.
Secondary outcome
Secondary outcome measures are the 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).
Background summary
Acquired brain injury (ABI) causes a wide variety of symptoms and frequently
leads to emotional disturbances. Research has shown that patients with ABI
experience high levels of anxiety and depressive symptoms. However, to date
effective treatments for these patients are lacking; both cognitive behavioral
therapy (CBT) and pharmacological treatments have shown disappointing results
in this patient population. A promising and upcoming therapy is Acceptance and
Commitment Therapy (ACT). ACT is a third wave behavioral therapy which does not
focus on symptom reduction, but on the improvement of psychological
flexibility. In contrast to CBT the dysfunctional cognitions of the patient are
not changed or challenged during an ACT treatment. ACT helps them to become
aware of their thoughts and emotions, and to accept them for what they are.
This may be a better fitting approach for patients with ABI since their
thoughts are often realistic. ACT has shown positive results in patients
suffering from depression, anxiety, obsessive compulsive disorder, psychosis,
and chronic pain. The studies examining the effectiveness of ACT for
individuals with ABI are, however, very limited.
Study objective
Examining the clinical and cost-effectiveness of ACT for individuals with ABI
who experience depressive and/or anxiety symptoms.
Study design
Single-blind multicenter randomized controlled trial (RCT) in which ACT is
compared to an active control group (psycho-education intervention combined
with relaxation exercises). Participants will be stratified according to type
of brain injury (i.e. stroke and traumatic brain injury) and location
(hospital).
Intervention
The participants will receive ACT or psycho-education combined with relaxation
training. Both interventions will consist of eight sessions which will last 60
till 90 minutes.
Study burden and risks
The burden for the participants is considered to be limited. Patients will have
to come to the hospital eight times for the individual therapy or
psycho-education sessions (and make homework) as part of their regular
treatment and five times to fill out several questionnaires. There is no
physical or physiological discomfort associated with participation.
Furthermore, a reduction of depressive and anxiety symptoms is expected for
participants in both the control as the ACT condition.
dr. Tanslaan 12
Maastricht 6229 ET
NL
dr. Tanslaan 12
Maastricht 6229 ET
NL
Listed location countries
Age
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.
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 | NL65349.068.18 |
| OMON | NL-OMON23617 |