Parkinson's DiseaseNCT02648737
Cognitive Behavioural Therapy for Anxiety Disorders in PD
A study testing Cognitive Behavioural Therapy (CBT) and Clinical monitoring in people with Parkinson's Disease and Generalized Anxiety Disorder, run by Maastricht University Medical Center at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Parkinson's Disease, Generalized Anxiety Disorder, Social Phobia
- What is being tested?
- Cognitive Behavioural Therapy (CBT) and Clinical monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Oct 2016to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- No other current psychological treatment for anxiety; pharmacotherapy (e.g., selective serotonin re-uptake inhibitors) 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.
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
France1 site
Neurology and Movement Disorders Unit, Lille University Hospital
Lille, 59037
Netherlands1 site
Maastricht University Medical Centre
Maastricht, 6202 AZ
About this study
Official title: Cognitive Behavioural Therapy for Anxiety Disorders in Patients With Parkinson's Disease: a Randomized, Controlled Trial of the Clinical Effectiveness and Changes in Cerebral Connectivity
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.
Read the 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.
- Being tested
- Cognitive Behavioural Therapy (CBT), Clinical monitoring
- Keywords
- Parkinson's disease, Cognitive Behavioural therapy, generalized anxiety disorder, social phobia, cerebral connectivity
- Medical subject headings
- Parkinson Disease, Generalized Anxiety Disorder, Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioural Therapy (CBT)Behavioural
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).
Clinical monitoringOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Clinical monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in anxiety score as measured with the Hamilton Anxiety Rating Scale (HARS).
Measured: 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)
Measured: 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
Measured: 3 months follow-up (T2) and 6 months follow-up (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2016 (estimated)
- Study startOct 2016
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Responsible party
- Principal investigator, Anja Moonen, Maastricht University Medical Center
- Investigators
- Albert FG Leentjens, MD, PhD, Study director, Maastricht University Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02648737
- Sponsor's protocol ID
- 11169
- Status last verified
- Feb 2020
- First submitted
- 5 Jan 2016
- Last updated
- 19 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Treatment module will be made available for public use. Study data will be published in peer-reviewed journals.
Publications
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.
PubMed 30097133
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioural Therapy for Anxiety Disorders in Patients With Parkinson's Disease: a Randomized, Controlled Trial of the Clinical Effectiveness and Changes in Cerebral Connectivity
- ClinicalTrials.gov ID
- NCT02648737
- Acronym / sponsor ID
- 11169
- Keywords
- Parkinson's disease, Cognitive Behavioural therapy, generalized anxiety disorder, social phobia, cerebral connectivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Study start
- Oct 2016
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 7 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioural Therapy (CBT) | Experimental | Behavioral: Cognitive Behavioural Therapy (CBT), Other: Clinical monitoringPatients 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. |
| Clinical monitoring | Other | Other: Clinical monitoringPatients 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. |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
- No other current psychological treatment for anxiety; pharmacotherapy (e.g., selective serotonin re-uptake inhibitors) 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.
- Signed informed consent
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Behavioural | Cognitive Behavioural Therapy (CBT) |
| Clinical monitoringPatients 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. | Other | Clinical monitoring, Cognitive Behavioural Therapy (CBT) |
Primary outcome
Change in anxiety score as measured with the Hamilton Anxiety Rating Scale (HARS).
Time frame: Baseline assessment (T0) and post-treatment assessment (T1; after 10 weeks)
2 secondary outcomes
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)
Time frame: 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
Time frame: 3 months follow-up (T2) and 6 months follow-up (T3)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2020.
- Derived from this study: PubMed 30097133Mulders 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.
- Individual participant dataSharing planned: Yes. Treatment module will be made available for public use. Study data will be published in peer-reviewed journals.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Albert FG Leentjens, MD, PhD study director
Maastricht University Medical Centre
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioural Therapy (CBT) and Clinical monitoring in people with Parkinson's Disease and Generalized Anxiety Disorder, run by Maastricht University Medical Center at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in anxiety score as measured with the Hamilton Anxiety Rating Scale (HARS). (time frame: Baseline assessment (T0) and post-treatment assessment (T1; after 10 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02648737, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2020.