Cognitive Behavioural Therapy for Anxiety Disorders in PD

NCT02648737 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-02-19

No results posted yet for this study

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

Interventions

BEHAVIORAL

Cognitive Behavioural Therapy (CBT)

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).

OTHER

Clinical monitoring

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.

Sponsors & Collaborators

  • Michael J. Fox Foundation for Parkinson's Research

    collaborator OTHER
  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • Albert FG Leentjens, MD, PhD · Maastricht University Medical Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • France
  • Netherlands

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02648737 on ClinicalTrials.gov