Parkinson DiseaseeParkNCT05585827
Online Cognitive Behavioral Therapy for Depressive Symptoms in Parkinson's Disease
A study testing Online cognitive behavioral therapy in people with Parkinson Disease and Depressive Symptoms, run by Helse Stavanger HF at 1 site in Norway.
Trial summary
More than 1 million people in Europe suffer from Parkinson's disease (PD), a brain disorder manifesting with a motor syndrome and several non-motor features. Neuropsychiatric symptoms, like anxiety and depression, are common in patients with PD, and has profound effects on quality of life and activities of daily… Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Parkinson Disease, Depressive Symptoms, Anxiety
- What is being tested?
- Online cognitive behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteNorway
- Study dates
- 7 Dec 2022to 27 Nov 2024
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written electronic consent;
- Confirmed PD clinical diagnosis based on self-report;
- A verified diagnosis of depression, according to previously published criteria;
- Age 35 to 85 years;
- Stable medication and mental health regiment (including antidepressants ≥ 6 weeks);
- Internet access from a computer or tablet.
Who cannot join
- Cognitive impairment as defined by Montreal Cognitive Assessment (MoCA) Blind version scores of <18;
- Suicidal thoughts with plan and intent (clinical interview);
- Medically unstable;
- Currently receiving psychotherapeutic treatment;
- History of bipolar or psychotic disorders;
- Does not speak Norwegian;
- A history with neurosurgery (like deep brain stimulation);
- No familiarity and/or access to a computer or tablet with camera, or internet access.
Trial locations and contacts
1 site in 1 country.
Norway1 site
Stavanger University Hospital, Norwegian Centre for Movement Disorders
Stavanger, 4068
About this study
Official title: A Decentralized Trial of Individual Video-assisted Cognitive Behavioural Therapy for Depressive Disorder in Parkinson's Disease.
More than 1 million people in Europe suffer from Parkinson's disease (PD), a brain disorder manifesting with a motor syndrome and several non-motor features. Neuropsychiatric symptoms, like anxiety and depression, are common in patients with PD, and has profound effects on quality of life and activities of daily living of the patient, and caregiver burden. Cognitive behavioral therapy (CBT) has proven efficient for depressive symptoms, but treatment availability to the general patient with PD is low. Thus, there is an urgent need for individualized remote approaches that can be of benefit to patients on a national scale. This study is a remote, randomized delayed start trial of the effectiveness of videoconference based cognitive behavioral therapy (eCBT) for PD patients with depressive symptoms. N=120 participants with PD and depressive symptoms will be recruited from neurological clinics across four health regions in Norway and self-reference, and randomized into two arms: (A) immediate eCBT with concurrent with TAU and (B) a delayed start (14 weeks) of eCBT with TAU alone. Patients will be assessed at baseline before allocation to treatment, with followed up evaluations 14, 28 and 42 weeks after baseline. The trial is designed as a state-of-the-art remote clinical trial, that can be easily implemented existing health services, resulting in a rapid implementation and improvement of treatment for patients with PD, and potentially large translational value to other brain disorders.
Read the detailed description
We will conduct a remote, randomized controlled trial with delayed start, in order to:
- Assess the 14-week effectiveness of eCBT for depressive symptoms for patients with PD.
- Assess long-term outcomes, and predictors of long-term outcomes, of eCBT for depressive symptoms in PD.
- Explore the impact and clinical correlates of working alliance in eCBT in patients with PD. For the first aim, we hypothesize that:
- 10 week eCBT will reduce the self-reported severity of depressive symptoms in patients with PD after 14 weeks, as compared to patients in a delayed start group, receiving treatment as usual (TAU). ii. 10 week eCBT will reduce the observed severity of depressive symptoms in patients with PD after 14 weeks, as compared to patients in a delayed start group, receiving TAU.
- 10 week eCBT will improve self-reported health related quality of life measured with The 8-item PD Questionnaire after 14 weeks, as compared to patient in a control group receiving TAU. For the second aim, we hypothesize: ii. Participants with 42 week follow up has lasting effects of eCBT, when compared to participants with 28 week follow up. iii. Long-term treatment response from eCBT for depressive symptoms, is predicted by the level of comorbid symptoms of anxiety and impulse control disorders at baseline. iv. Long-term treatment response from eCBT for depressive symptoms, is predicted by the level of comorbid symptoms of anxiety and impulse control disorders at the time of treatment completion. For the third aim, we hypothesize:
- The interrater agreement between patients and CBT therapist on working alliance will be a significant predictor of the acceptability of eCBT, as defined by patient reported experience measures.
- Conditions
- Parkinson Disease, Depressive Symptoms, Anxiety
- Being tested
- Online cognitive behavioral therapy
- Keywords
- Parkinsons disease, Neuropsychiatry, Cognitive behavioral therapy
- Medical subject headings
- Parkinson Disease, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online cognitive behavioral therapyBehavioural
The e-CBT treatment manual is an adjusted version of a previously published treatment manuals for neuropsychiatric symptoms in PD, which is tailored to the preferences and needs for each participant. This manual encompass both modules from manuals for depression in PD and anxiety in PD. Individualization is ensures by including several interventions modules in the manual, wherein 5 sessions are considered "core modules", and four modules that can be offered depending on the patients individual needs. The participant may include partners or caregivers. The treatment is schedules to be completed within 13 weeks, with maximum ten sessions during this period. Following each e-CBT session, the participant will be asked to complete a short survey evaluating the acceptability and relevance of the session, and evaluate the therapeutic alliance.
| Study group | Role | What they receive |
|---|---|---|
| Immediate eCBT with concurrent TAU | Experimental | Those randomized into the this group will get immediate e-CBT with TAU. Receives: Behavioral: Online cognitive behavioral therapy |
| Delayed eCBT with concurrent TAU | No intervention | Those randomized to the delayed arm of the study, will receive TAU and wait 14 weeks before receiving the intervention. TAU will include ongoing review by the patient's primary care physician, neurologist and PD nurse. TAU does not preclude clinically indicated adjustments to medication or specialist referrals but physicians are asked to keep medication constant if possible. For patients with PD ordinary treatment includes a multitude of interventions, including pharmacological treatment, speech therapy and physical therapy. Pharmacological interventions include the use of dopaminergic treatments, including levodopa and dopamine agonist use, with adjunct use of monoamine oxidase B-inhibitors. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in The Clinical Global Impression scale (CGI) score
A clinical-rated measure of general symptom severity of neuropsychiatric symptoms.
Measured: Baseline (BL) to 14 weeks
Change in the Hospital Anxiety and Depression Scale (HADS), score
HADS is a commonly used self-report 14-item scale for the assessment of anxiety and depression in PD.
Measured: Baseline (BL) to 14 weeks
Change in the 8-item PD Questionnaire
The 8-item version of the Parkinson's Disease Questionnaire (PDQ-8) is a shortened version of the 39-item Parkinson's Disease Questionnaire (PDQ-39). It was developed to reduce the respondent burden and increase convenience for use among persons with Parkinson's Disease in clinical settings.
Measured: Baseline (BL) to 14 weeks
Secondary outcomes (8)
Change in the Automatic Thoughts Questionnaire-30- Negative (ATQ-30-N) score
is a 30-item self-report measure of the frequency of automatic negative thoughts associated with depression and anxiety.
Measured: Baseline, 14, 28 and 42 weeks
Change in the The Behavioural Activation for Depression Scale (BADS) score
BADS is a 25-item self-report measure developed to measure the changes in activation and avoidance over the course of treatment of depression.
Measured: Baseline, 14, 28 and 42 weeks
Change in The 39-item PD Questionnaire (PDQ-8) score
The PDQ-8 is a brief, valid and reliable patient reported outcome measure instrument to assess HRQoL in patients with PD with good concordant validity to generic HRQoL-scales.
Measured: Baseline, 14, 28 and 42 weeks
The Negative Effects Questionnaire (NEQ)
NEQ is a 20 item self-report questionnaire measuring adverse and unwanted effects for psychological treatments.
Measured: 14, 28 and 42 weeks
Change in the Parkinson Anxiety Scale (PAS) score
PAS is a 12-item self-report questionnaire measuring anxiety symptoms in patients with PD.
Measured: Baseline, 14, 28 and 42 weeks
Patient reported experience measure (PREM):
Participants experiences will be assessed with a six item questionnaire, scored on a visual analogue scale anchored with ''not at all'' to ''very much''. The questionnaire is comprised of six question indices: (1) interesting, (2) easy to understand, (3) useful, (4) extent to which the intervention provided novel information, (5) satisfaction, and (6) relevance.
Measured: 14, 28 and 42 weeks
Patient version of the Working Alliance Inventory (WAI):
WAI is a 12-item questionnaire evaluating the working alliance between patients and the CBT-therapist.
Measured: 14, 28 and 42 weeks
Change in the Parkinson's Disease Impulsive-Compulsive Disorders Questionnaire Rating scale (QUIP-RS) score
QUIP-RS is a quick assessment of the severity of impulsive and compulsive behaviors in Parkinsons disease.
Measured: Baseline, 14, 28 and 42 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2022
- Study start7 Dec 2022
- Primary completion27 Nov 2024
- Study completion27 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- 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
- Crossover
- Model description
- This study is a online, randomized delayed start trial of the effectiveness of e-CBT for PD patients with depressive symptoms.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Stavanger HF
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Aleksander H Erga, PhD, Principal investigator, Norwegian Centre for Movement Disorders, Stavanger University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05585827
- Sponsor's protocol ID
- 3414-3414
- Acronym
- ePark
- Status last verified
- Nov 2024
- First submitted
- 20 Sep 2022
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Erga AH, Alves G, Leentjens AFG. The ePark study protocol: A decentralized trial of individual video-assisted cognitive behavioural therapy for depressive disorder in Parkinson's disease. Contemp Clin Trials Commun. 2023 Feb 3;32:101080. doi: 10.1016/j.conctc.2023.101080. eCollection 2023 Apr. No abstract available.
PubMed 36817735Erga AH, Alves G, Leentjens AFG. Corrigendum to "The ePark study protocol: A decentralized trial of individual video-assisted cognitive behavioural therapy for depressive disorder in Parkinson's disease" [Contemp. Clinic. Trials Commun. 32 (2023) 101080]. Contemp Clin Trials Commun. 2023 Aug 29;35:101205. doi: 10.1016/j.conctc.2023.101205. eCollection 2023 Oct.
PubMed 37745287
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Decentralized Trial of Individual Video-assisted Cognitive Behavioural Therapy for Depressive Disorder in Parkinson's Disease.
- ClinicalTrials.gov ID
- NCT05585827
- Acronym / sponsor ID
- ePark / 3414-3414
- Conditions
- Parkinson Disease, Depressive Symptoms, Anxiety
- Keywords
- Parkinsons disease, Neuropsychiatry, Cognitive behavioral therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Helse Stavanger HFOther government
- Study start
- 7 Dec 2022 (actual)
- Primary completion
- 27 Nov 2024 (actual)
- Study completion
- 27 Nov 2024 (actual)
- First posted
- 19 Oct 2022 (actual)
- 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.
More than 1 million people in Europe suffer from Parkinson's disease (PD), a brain disorder manifesting with a motor syndrome and several non-motor features. Neuropsychiatric symptoms, like anxiety and depression, are common in patients with PD, and has profound effects on quality of life and activities of daily living of the patient, and caregiver burden. Cognitive behavioral therapy (CBT) has proven efficient for depressive symptoms, but treatment availability to the general patient with PD is low. Thus, there is an urgent need for individualized remote approaches that can be of benefit to patients on a national scale. This study is a remote, randomized delayed start trial of the effectiveness of videoconference based cognitive behavioral therapy (eCBT) for PD patients with depressive symptoms. N=120 participants with PD and depressive symptoms will be recruited from neurological clinics across four health regions in Norway and self-reference, and randomized into two arms: (A) immediate eCBT with concurrent with TAU and (B) a delayed start (14 weeks) of eCBT with TAU alone. Patients will be assessed at baseline before allocation to treatment, with followed up evaluations 14, 28 and 42 weeks after baseline. The trial is designed as a state-of-the-art remote clinical trial, that can be easily implemented existing health services, resulting in a rapid implementation and improvement of treatment for patients with PD, and potentially large translational value to other brain disorders.
Detailed description
We will conduct a remote, randomized controlled trial with delayed start, in order to:
- Assess the 14-week effectiveness of eCBT for depressive symptoms for patients with PD.
- Assess long-term outcomes, and predictors of long-term outcomes, of eCBT for depressive symptoms in PD.
- Explore the impact and clinical correlates of working alliance in eCBT in patients with PD. For the first aim, we hypothesize that:
- 10 week eCBT will reduce the self-reported severity of depressive symptoms in patients with PD after 14 weeks, as compared to patients in a delayed start group, receiving treatment as usual (TAU). ii. 10 week eCBT will reduce the observed severity of depressive symptoms in patients with PD after 14 weeks, as compared to patients in a delayed start group, receiving TAU.
- 10 week eCBT will improve self-reported health related quality of life measured with The 8-item PD Questionnaire after 14 weeks, as compared to patient in a control group receiving TAU. For the second aim, we hypothesize: ii. Participants with 42 week follow up has lasting effects of eCBT, when compared to participants with 28 week follow up. iii. Long-term treatment response from eCBT for depressive symptoms, is predicted by the level of comorbid symptoms of anxiety and impulse control disorders at baseline. iv. Long-term treatment response from eCBT for depressive symptoms, is predicted by the level of comorbid symptoms of anxiety and impulse control disorders at the time of treatment completion. For the third aim, we hypothesize:
- The interrater agreement between patients and CBT therapist on working alliance will be a significant predictor of the acceptability of eCBT, as defined by patient reported experience measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a online, randomized delayed start trial of the effectiveness of e-CBT for PD patients with depressive symptoms.
| Arm | Type | Receives |
|---|---|---|
| Immediate eCBT with concurrent TAU | Experimental | Behavioral: Online cognitive behavioral therapyThose randomized into the this group will get immediate e-CBT with TAU. |
| Delayed eCBT with concurrent TAU | No intervention | –Those randomized to the delayed arm of the study, will receive TAU and wait 14 weeks before receiving the intervention. TAU will include ongoing review by the patient's primary care physician, neurologist and PD nurse. TAU does not preclude clinically indicated adjustments to medication or specialist referrals but physicians are asked to keep medication constant if possible. For patients with PD ordinary treatment includes a multitude of interventions, including pharmacological treatment, speech therapy and physical therapy. Pharmacological interventions include the use of dopaminergic treatments, including levodopa and dopamine agonist use, with adjunct use of monoamine oxidase B-inhibitors. |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed written electronic consent;
- Confirmed PD clinical diagnosis based on self-report;
- A verified diagnosis of depression, according to previously published criteria;
- Age 35 to 85 years;
- Stable medication and mental health regiment (including antidepressants ≥ 6 weeks);
Key exclusion criteria (8 listed)
- Cognitive impairment as defined by Montreal Cognitive Assessment (MoCA) Blind version scores of <18;
- Suicidal thoughts with plan and intent (clinical interview);
- Medically unstable;
- Currently receiving psychotherapeutic treatment;
- History of bipolar or psychotic disorders;
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 |
|---|---|---|
| Online cognitive behavioral therapyThe e-CBT treatment manual is an adjusted version of a previously published treatment manuals for neuropsychiatric symptoms in PD, which is tailored to the preferences and needs for each participant. This manual encompass both modules from manuals for depression in PD and anxiety in PD. Individualization is ensures by including several interventions modules in the manual, wherein 5 sessions are considered "core modules", and four modules that can be offered depending on the patients individual needs. The participant may include partners or caregivers. The treatment is schedules to be completed within 13 weeks, with maximum ten sessions during this period. Following each e-CBT session, the participant will be asked to complete a short survey evaluating the acceptability and relevance of the session, and evaluate the therapeutic alliance. | Behavioural | Immediate eCBT with concurrent TAU |
Primary outcome
Change in The Clinical Global Impression scale (CGI) score
Time frame: Baseline (BL) to 14 weeks
A clinical-rated measure of general symptom severity of neuropsychiatric symptoms.
Change in the Hospital Anxiety and Depression Scale (HADS), score
Time frame: Baseline (BL) to 14 weeks
HADS is a commonly used self-report 14-item scale for the assessment of anxiety and depression in PD.
Change in the 8-item PD Questionnaire
Time frame: Baseline (BL) to 14 weeks
The 8-item version of the Parkinson's Disease Questionnaire (PDQ-8) is a shortened version of the 39-item Parkinson's Disease Questionnaire (PDQ-39). It was developed to reduce the respondent burden and increase convenience for use among persons with Parkinson's Disease in clinical settings.
8 secondary outcomes
Change in the Automatic Thoughts Questionnaire-30- Negative (ATQ-30-N) score
Time frame: Baseline, 14, 28 and 42 weeks
Change in the The Behavioural Activation for Depression Scale (BADS) score
Time frame: Baseline, 14, 28 and 42 weeks
Change in The 39-item PD Questionnaire (PDQ-8) score
Time frame: Baseline, 14, 28 and 42 weeks
The Negative Effects Questionnaire (NEQ)
Time frame: 14, 28 and 42 weeks
Change in the Parkinson Anxiety Scale (PAS) score
Time frame: Baseline, 14, 28 and 42 weeks
Patient reported experience measure (PREM):
Time frame: 14, 28 and 42 weeks
Patient version of the Working Alliance Inventory (WAI):
Time frame: 14, 28 and 42 weeks
Change in the Parkinson's Disease Impulsive-Compulsive Disorders Questionnaire Rating scale (QUIP-RS) score
Time frame: Baseline, 14, 28 and 42 weeks
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 5 Dec 2024.
- Background: PubMed 36817735Erga AH, Alves G, Leentjens AFG. The ePark study protocol: A decentralized trial of individual video-assisted cognitive behavioural therapy for depressive disorder in Parkinson's disease. Contemp Clin Trials Commun. 2023 Feb 3;32:101080. doi: 10.1016/j.conctc.2023.101080. eCollection 2023 Apr. No abstract available.
- Background: PubMed 37745287Erga AH, Alves G, Leentjens AFG. Corrigendum to "The ePark study protocol: A decentralized trial of individual video-assisted cognitive behavioural therapy for depressive disorder in Parkinson's disease" [Contemp. Clinic. Trials Commun. 32 (2023) 101080]. Contemp Clin Trials Commun. 2023 Aug 29;35:101205. doi: 10.1016/j.conctc.2023.101205. eCollection 2023 Oct.
- Study website (Norwegian)Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Aleksander H Erga, PhD principal investigator
Norwegian Centre for Movement Disorders, Stavanger University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online cognitive behavioral therapy in people with Parkinson Disease and Depressive Symptoms, run by Helse Stavanger HF at 1 site in Norway.
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 8 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 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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 The Clinical Global Impression scale (CGI) score (time frame: Baseline (BL) to 14 weeks). The study lists 3 primary outcomes in all. 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 NCT05585827, which also lists 2 linked publications.
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 5 Dec 2024.