Study protocol for the MIND-PD study: a randomized controlled trial to investigate clinical and biological effects of mindfulness-based cognitive therapy in people with Parkinson's disease.
Study Goal
The researchers aimed to determine the efficacy of Mindfulness-Based Cognitive Therapy (MBCT) in reducing anxiety and depression symptoms in people with Parkinson's disease (PD) and explore its effects on motor symptoms, stress markers, and PD progression biomarkers.
Results Summary
The study is a prospective randomized controlled trial (RCT) investigating MBCT's effects on anxiety and depression in PD patients, with additional exploratory outcomes on motor symptoms, stress markers, and PD biomarkers. Results are pending as the study is ongoing.
Population
124 PD patients with mild-moderate anxiety and depression symptoms, disease duration ≤10 years, eligible for MRI, and naïve to mindfulness.
Effective Dosage
8 weeks of MBCT (specific frequency not detailed).
Duration
8 weeks of intervention, with 12-month follow-up.
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
Mindfulness-Based Cognitive Therapy (MBCT) | decrease | symptoms of anxiety and depression | people with Parkinson's disease (PD) | - | reduce | #1 |
Mindfulness-Based Cognitive Therapy (MBCT) | neutral | motor symptom severity | people with Parkinson's disease (PD) | - | has an effect on | #2 |
Mindfulness-Based Cognitive Therapy (MBCT) | neutral | cerebral and biochemical markers of stress | people with Parkinson's disease (PD) | - | influences | #3 |
Mindfulness-Based Cognitive Therapy (MBCT) | neutral | biomarkers of PD progression | people with Parkinson's disease (PD) | - | leads to a change in | #4 |
BACKGROUND: People with Parkinson's disease (PD) are very sensitive to the effects of stress. The prevalence of stress-related neuropsychiatric symptoms is high, and acute stress worsens motor symptoms. Animal studies suggest that chronic stress may accelerate disease progression, but evidence for this in humans is lacking. Mindfulness-based interventions (MBIs) train participants to focus on the present moment, on purpose and without judgement. Previous studies suggest that MBIs may alleviate stress and reduce depression and anxiety in PD. We aim to demonstrate the efficacy of Mindfulness-Based Cognitive Therapy (MBCT) as a non-pharmacologic treatment strategy for neuropsychiatric (and motor) symptoms in PD, and to identify the mechanisms underlying stress and stress reduction in PD. METHODS: In a prospective randomized controlled trial (RCT), we investigate whether 8 weeks of MBCT, as compared to care as usual, can reduce symptoms of anxiety and depression in people with PD. We aim to include 124 PD patients, who experience mild-moderate symptoms of anxiety and depression, are eligible for magnetic resonance imaging (MRI) and naïve to mindfulness, and who have a disease duration ≤ 10 years. Every participant is followed for 12 months. Clinical and biochemical assessments take place at baseline (T0), after 2 months (T1), and after 12 months (T2); MRI assessments take place at T0 and T2. Our primary outcome is the total score on the Hospital Anxiety and Depression Scale (HADS) at T1, while correcting for the HADS score at T0, age, and gender. Beyond testing the effects of MBCT on symptoms of anxiety and depression in PD, we explore whether MBCT: (1) has an effect on motor symptom severity, (2) influences cerebral and biochemical markers of stress, and (3) leads to a change in biomarkers of PD progression. DISCUSSION: MIND-PD is one of the first RCTs with a 1-year follow-up to investigate the effects of MBCT on symptoms of anxiety and depression in PD, and to explore possible mechanisms underlying stress and stress reduction in PD. Insight into these mechanisms can pave the way to new treatment methods in the future. TRIAL REGISTRATION: ClinicalTrials.gov, NCT05779137. Registered on 12 January 2023.