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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02705586
Other study ID # 15421
Secondary ID 38255410
Status Completed
Phase N/A
First received
Last updated
Start date March 2016
Est. completion date July 2016

Study information

Verified date October 2019
Source Oregon Health and Science University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 13
Est. completion date July 2016
Est. primary completion date July 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Mindfulness
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.

Locations

Country Name City State
United States Oregon Health & Science University Portland Oregon
United States VA Portland Health Care System Portland Oregon

Sponsors (2)

Lead Sponsor Collaborator
Oregon Health and Science University Portland VA Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (3)

Achey M, Aldred JL, Aljehani N, Bloem BR, Biglan KM, Chan P, Cubo E, Dorsey ER, Goetz CG, Guttman M, Hassan A, Khandhar SM, Mari Z, Spindler M, Tanner CM, van den Haak P, Walker R, Wilkinson JR; International Parkinson and Movement Disorder Society Teleme — View Citation

Almeida DM, Wethington E, Kessler RC. The daily inventory of stressful events: an interview-based approach for measuring daily stressors. Assessment. 2002 Mar;9(1):41-55. — View Citation

Armento ME, Stanley MA, Marsh L, Kunik ME, York MK, Bush AL, Calleo JS. Cognitive behavioral therapy for depression and anxiety in Parkinson's disease: a clinical review. J Parkinsons Dis. 2012;2(2):135-51. doi: 10.3233/JPD-2012-12080. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Salivary Cortisol Levels (Pre- and Post-) Mindfulness-Based Stress Reduction Program Enzyme-linked immunoassay salivary cortisol levels (ng/mL) taken prior to Mindfulness-Based Stress Reduction will be compared to samples taken after the intervention. Baseline to 12 weeks
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