NCT05585827Completed
Online Cognitive Behavioral Therapy for Depressive Symptoms in Parkinson's Disease
A Decentralized Trial of Individual Video-assisted Cognitive Behavioural Therapy for Depressive Disorder in Parkinson's Disease.
Source: ClinicalTrials.gov · Last updated 5 Dec 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 11 (actual)
- First submitted
- 20 Sept 2022
- Start date
- 7 Dec 2022
- Primary completion date
- 27 Nov 2024
- Lead sponsor
- Helse Stavanger HF
- Diseases
- Parkinson disease
- NCT number
- NCT05585827
What you commit to
- Study type: Interventional
- Participants enrolled: 11
- From 7 Dec 2022 to the primary completion date, 27 Nov 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently receiving psychotherapeutic treatment;
Other illness
- Cognitive impairment as defined by Montreal Cognitive Assessment (MoCA) Blind version scores of \<18;
- History of bipolar or psychotic disorders;
Other
- Suicidal thoughts with plan and intent (clinical interview);
- Medically unstable;
- 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.
Who the study is looking for
- 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.
Age in the registry: 35 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Stavanger University Hospital, Norwegian Centre for Movement Disorders Coordinator of this site? Confirm its status | Stavanger | Norway | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.