The present study aims to study the clinical effectiveness of a CBT module for anxiety in PD. This module is based on existing modules for anxiety disorders in non-PD patients, and on modules for depression and impulse control disorders in PD…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is the difference in change in anxiety score
between baseline and post-treatment as measured with the Hamilton Anxiety
Rating Scale (HARS) between the intervention- and control group.
Secondary outcome
- Differences in changes between the intervention- and control group in
cerebral connectivity between limbic and frontal cortices before and after
treatment, as measured with resting state BOLD fMRI and DTI.
- Long term clinical effectiveness of the CBT module, measured by the change in
HARS score after 3 months (between group) and 6 months (within group) follow-up
in the intervention- and control group.
- The difference between the intervention- and control group in generic
health-related quality of life (EQ-5D-5L and PDQ8) and well-being (ICECAP-O)
before and after treatment.
- The cost-effectiveness of CBT as treatment for anxiety in PD patients as
measured by the Resource Use Questionnaire.
Background summary
Anxiety disorders occur in up to 35% of patients with Parkinson*s disease (PD)
and have a negative effect on several motor symptoms and quality of life. So
far, there is no treatment, neither pharmacological nor psychotherapeutic, that
intends to specifically reduce anxiety symptoms in PD. Cognitive Behavioural
Therapy (CBT) is an effective treatment for anxiety disorders in patients
without PD. In PD, CBT is an effective treatment for depression and for impulse
control disorders (ICD), compared to PD patients who only receive clinical
monitoring. In addition, recent neuroimaging studies have demonstrated the
therapeutic effects of CBT on functional neural activity.
Study objective
The present study aims to study the clinical effectiveness of a CBT module for
anxiety in PD. This module is based on existing modules for anxiety disorders
in non-PD patients, and on modules for depression and impulse control disorders
in PD patients. In addition, we aim to get more insight into biological
dysfunction associated with anxiety in PD, as well as alterations in brain
structure, brain function and cerebral connectivity due to CBT in order to
unravel the biological correlates of successful treatment. Effective CBT
treatment of anxiety will provide patients with behavioural and anxiety
management techniques that can give lasting benefits, not only on anxiety
symptoms, but potentially also on motor symptoms.
Study design
This study involves a Randomized Controlled Trial (RCT) with PD patients
recruited in two centres in Europe ( Maastricht Universitair Medical Centre
(Netherlands) en Lille 2 Medical university (France) who will be randomized to
CBT plus clinical monitoring or clinical monitoring only. All participants will
undergo baseline clinical assessment (including MRI scan), post-treatment
clinical assessment (including MRI scan), 3 months follow-up clinical
assessment and a 6 months follow-up clinical assessment (only for patients
randomized to CBT plus clinical monitoring). Patients who receive clinical
monitoring only will be given the option to receive CBT 3 months after the
baseline assessment.
Intervention
Patients who will receive CBT plus clinical monitoring (intervention group)
will receive weekly individual sessions, tailored to the preferences and needs
of each patient. In each session, a registered psychologist will address
specified aspects of (coping with) anxiety and related concerns. Several topics
of anxiety will be integrated with a specific focus on behaviour and thoughts
associated with anxiety. Patients assigned to clinical monitoring only (control
group) will receive general education material on coping anxiety symptoms, not
specific for PD.
Study burden and risks
To our knowledge, there are no major risks associated with participating in the
CBT intervention. We do not expect the content of the modules to be too
confronting or emotionally stressful to cause any psychological harm to the
participants, because the sessions will be tailored to the needs and concerns
of participants and the content of the modules is based on the needs of the
target population and the knowledge of PD experts. However, we acknowledge that
participating in the CBT intervention can be time-consuming and demanding for
participants. However, the current CBT module can provide them with behavioural
and anxiety management techniques that can be used to achieve longer-term
benefits and therewith reducing the risk of relapse.
Moreover, there is a low risk for undergoing MRI.
Dr. Tanslaan 12
Maastricht 6229ET
NL
Dr. Tanslaan 12
Maastricht 6229ET
NL
Listed location countries
Age
Inclusion criteria
* Idiopathic PD according to the Queens Square Brain Bank diagnostic criteria
* Presence of clinically relevant anxiety symptoms
* Using a stable dose of levodopa or other antiparkinsonian medication for at least one month
* No other current psychological treatment for anxiety; pharmacotherapy (e.g., SSRIs) is allowed if a stable dose is used at least 2 months prior to participation and the patient still meets inclusion criteria. During the trial the dosage should not be changed. Medication use and mental health care will be tracked throughout the study.
* Age between 35 and 80 years
* Signed informed consent
Exclusion criteria
* Parkinsonian syndromes or neurodegenerative disorders other than PD
* Dementia or severe cognitive decline
* Major depressive disorder (MDD) as defined by the criteria of a DSM-V diagnosis for MDD
* Abuse of alcohol, drugs or benzodiazepines.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02648737 |
| CCMO | NL56176.068.16 |