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OpenTrials
Completed

NCT Number: NCT02705586

Video Based Mindfulness Based Stress Reduction

To evaluate the feasibility of a video based mindfulness intervention for stress reduction and to evaluate the cortisol response in persons with PD and their caregivers. The data from this project will be used for a future grant application of a stress reduction intervention in persons with PD.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Health & Science University, Portland, Oregon, United States

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About this study

Participants will be enrolled at the VA Portland and have a baseline assessment. The baseline will assess neurological disorders (including Parkinsonism) and current stress. All participants will attend 10 weeks of mindfulness based stress reduction (MBSR) through video feed on the Portland VA campus. During the week prior to the first class and the week after the last class, participants will complete questionnaires regarding stress, collect saliva samples, and, for the Parkinson's patient, monitor motor symptoms of PD using diaries and inertial sensors. A final visit will assess stress, neurological diseases, and Parkinsonism.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Parkinson's disease
  • Some Postural instability
  • Tremor in upper limb
  • Caregiver willing to also participate

Exclusion criteria

  • No neurological disease
  • Cognitive deficits
  • Other neurological/psychological disorder
  • Completion of a stress reduction program in the last 12 months

Treatment and study plan

Mindfulness

Behavioral

Mindfulness focuses on helping participants understand their personal reactions to stress, teaches skills that provide means to modify stress reactions, and promotes self-care and feelings of competence and mastery. In addition to weekly class sessions, participants are asked to do an hour of home practice the days that the class does not meet.

Other names: Mindfulness Based Stress REduction

Primary outcomes

  1. Salivary Cortisol Levels (Pre- and Post-) Mindfulness-Based Stress Reduction Program

    Time frame: Baseline to 12 weeks

    Enzyme-linked immunoassay salivary cortisol levels (ng/mL) taken prior to Mindfulness-Based Stress Reduction will be compared to samples taken after the intervention.

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • Portland VA Medical Center

Registry information

Acronym: vMBSR

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 10, 2016
Registry last updated
Oct 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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