Cognitive Behavioural Therapy for Anxiety Disorders in PD

NCT02648737 | Completed DMC

• 1 other identifier: 11169
• Study Type: interventional
• Target: 50
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Parkinson's Disease; Generalized Anxiety Disorder; Social Phobia

Keywords

Parkinson's disease; Cognitive Behavioural therapy; generalized anxiety disorder; social phobia; cerebral connectivity

Outcome Measures

Primary Outcomes (1)

• Change in anxiety score as measured with the Hamilton Anxiety Rating Scale (HARS).

  Baseline assessment (T0) and post-treatment assessment (T1; after 10 weeks)

Secondary Outcomes (2)

• Changes in cerebral connectivity between limbic and frontal cortices as measured with resting state blood-oxygen-level dependent functional magnetic resonance imaging (BOLD fMRI) and diffusion tensor imaging (DTI)

  MRI scanning at baseline (T0) and post-treatment (T1; after 10 weeks)

• Long term clinical effectiveness of the CBT module measured by the change in HARS score

  3 months follow-up (T2) and 6 months follow-up (T3)

Study Arms (2)

Cognitive Behavioural Therapy (CBT)

EXPERIMENTAL

Patients who will receive CBT plus clinical monitoring will receive 10 weekly individual sessions (60-75 minutes), 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 with a specific focus on behaviour and thoughts associated with anxiety.

Behavioral: Cognitive Behavioural Therapy (CBT); Other: Clinical monitoring

Clinical monitoring

OTHER

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. Patients who receive clinical monitoring only will be given the option to receive CBT once the trial is completed.

Other: Clinical monitoring

Interventions

Cognitive Behavioural Therapy (CBT) BEHAVIORAL

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).

Cognitive Behavioural Therapy (CBT)

Clinical monitoring OTHER

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.

Clinical monitoring; Cognitive Behavioural Therapy (CBT)

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Idiopathic PD according to the Queens Square Brain Bank diagnostic criteria
• Presence of clinically relevant anxiety symptoms, as operationalized by the Mini International Neuropsychiatric Inventory (MINI), sections for social phobia (F) and GAD (H), and/or a Parkinson Anxiety Scale (PAS) persistent score \>9 and/or PAS avoidance score \>3.
• Using a stable dose of levodopa or other antiparkinsonian medication for at least one month
• Signed informed consent
• Note: In order to achieve a representative study sample, patients will be included irrespective of their disease stage or their current antiparkinsonian medication.

You may not qualify if:

• Parkinsonian syndromes or neurodegenerative disorders other than PD
• Dementia or severe cognitive decline, operationalized as a Montreal Cognitive Assessment (MOCA) score \< 24
• Contra-indications for magnetic resonance imaging
• Major depressive disorder (MDD) as defined by the criteria of a DSM-V diagnosis for MDD
• Abuse of alcohol, drugs or benzodiazepines.

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Michael J. Fox Foundation for Parkinson's Research: collaborator

Study Sites (2)

Neurology and Movement Disorders Unit, Lille University Hospital

Lille, 59037, France

Location

Maastricht University Medical Centre

Maastricht, 6202 AZ, Netherlands

Location

Related Publications (1)

• Mulders AEP, Moonen AJH, Dujardin K, Kuijf ML, Duits A, Flinois B, Handels RLH, Lopes R, Leentjens AFG. Cognitive behavioural therapy for anxiety disorders in Parkinson's disease: Design of a randomised controlled trial to assess clinical effectiveness and changes in cerebral connectivity. J Psychosom Res. 2018 Sep;112:32-39. doi: 10.1016/j.jpsychores.2018.04.002. Epub 2018 Apr 10.

  PMID: 30097133 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Generalized Anxiety Disorder; Phobia, Social

Interventions

Cognitive Behavioral Therapy; Clinical Trials Data Monitoring Committees

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Anxiety Disorders; Mental Disorders; Phobic Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Professional Staff Committees; Quality Assurance, Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Albert FG Leentjens, MD, PhD

  Maastricht University Medical Centre

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: post doctoral researcher

Study Record Dates

• First Submitted: January 5, 2016
• First Posted: January 7, 2016
• Study Start: October 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: February 19, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share

Locations

FR (1); NL (1)