Cognitive Behavioural Therapy for Anxiety Disorders in PD
Condition: Parkinson's Disease; Generalized Anxiety Disorder; Social Phobia
MeSH terms: Parkinson Disease; Anxiety Disorders; Phobia, Social
Study type: Interventional

Summary: 
      Anxiety disorders occur in up to 35% of patients with Parkinson's disease (PD) and have a
      negative effect on gait, dyskinesia, freezing, on/off fluctuations, and quality of life. With
      this Randomized Controlled Trial the investigators intend to 1) develop a Cognitive
      Behavioural Therapy (CBT) module for anxiety in PD 2) assess the effectiveness of this module
      in reducing anxiety symptoms, and 3) study the effects of CBT on cerebral connectivity.
      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.
    

Detailed description: 
      Anxiety is common in patients with Parkinson's disease (PD) and has a negative effect on
      several motor symptoms and quality of life in general. 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). PD patients who received CBT for depression reported not only a
      reduction in depression and comorbid anxiety, but also a beneficial influence on coping and
      quality of life, compared to PD patients who only received clinical monitoring. In addition
      to the clinical effectiveness, several studies have demonstrated the therapeutic effects of
      CBT on functional neural activity. The two most common anxiety disorders in patients with
      Parkinson's Disease (PD): generalized anxiety disorder (GAD) and social anxiety disorder
      (SAD) are both characterized by dysfunctional connectivity between limbic areas (among which
      the amygdala) and the frontal cortex. Recent functional imaging studies have shown that CBT
      can alter neural correlates of affective processing by increasing functional connectivity
      between limbic and frontal cortices. The present study aims to study the clinical
      effectiveness of a CBT module for the treatment of the two most common anxiety disorders in
      patients with Parkinson's Disease (PD): generalized anxiety disorder (GAD) and social anxiety
      disorder (SAD) in a randomized controlled trial (RCT). The CBT module will be based on
      existing modules for anxiety disorders in non-PD patients, and on modules for depression and
      ICD in PD patients. In addition, the investigators 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. The investigators will study the biological
      correlates of successful treatment by using structural and functional magnetic
      resonance-imaging (MRI) scanning. The present study further aims to study the long term
      clinical effectiveness of the CBT module, measured by the change anxiety score after 3 and 6
      months follow-up.
    

Intervention name(s): Cognitive Behavioural Therapy (CBT); Clinical monitoring
Intervention type(s): Behavioral; Other
Intervention description(s): Cognitive Behavioural Therapy (CBT) is considered the gold standard in psychotherapeutic treatments of anxiety. CBT is defined as: 'An amalgam of behavioural and cognitive problem-based interventions guided by principles of applied science. The behavioural interventions aim to decrease maladaptive behaviours and increase adaptive ones by modifying their antecedents and consequences and by behavioural practices that result in new learning. The cognitive interventions aim to modify maladaptive cognitions, self-statements, or beliefs.' (Arch & Craske, 2009; Craske, 2010).; Patients assigned to clinical monitoring only will receive general education material on coping with PD symptoms and behavioural symptoms such as anxiety. In addition, they will be followed-up 1 month after baseline assessment via telephone calls to inquire about current anxiety symptoms. Patients will remain under the care of their personal physicians, who will also monitor their medical and psychiatric status.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Parkinson's disease; Cognitive Behavioural therapy; generalized anxiety disorder; social phobia; cerebral connectivity