NCT02705586

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 10, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

October 31, 2019

Completed
Last Updated

October 31, 2019

Status Verified

October 1, 2019

Enrollment Period

4 months

First QC Date

March 7, 2016

Results QC Date

November 5, 2018

Last Update Submit

October 7, 2019

Conditions

Parkinson's Disease

Keywords

Movement disordersMetabolic Stress

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

only one arm - open label study

EXPERIMENTAL

2 hour video based mindfulness-based stress reduction class once a week for 10 weeks.

Behavioral: Mindfulness

Interventions

MindfulnessBEHAVIORAL

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.

Also known as: Mindfulness Based Stress REduction
only one arm - open label study

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

VA Portland Health Care System

Portland, Oregon, 97239, United States

Location

Related Publications (3)

  • 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.

    PMID: 23939438BACKGROUND

  • 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 Telemedicine Task Force. The past, present, and future of telemedicine for Parkinson's disease. Mov Disord. 2014 Jun;29(7):871-83. doi: 10.1002/mds.25903. Epub 2014 May 17.

    PMID: 24838316RESULT

  • 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. doi: 10.1177/1073191102091006.

    PMID: 11911234RESULT

MeSH Terms

Conditions

Parkinson DiseaseMovement Disorders

Interventions

MindfulnessMindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Results Point of Contact

Title
Dr. Amie Hiller
Organization
VA Portland Health Care System
peterami@ohsu.edu
503 721 1091

Study Officials

  • Amie L Hiller (Peterson), MD

    VA Porltand Health Care system

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 7, 2016

First Posted

March 10, 2016

Study Start

March 1, 2016

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

October 31, 2019

Results First Posted

October 31, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

US(2)