Clinical trial NCT03859180: Self-Managed Intervention for Anxiety in Parkinson's Disease
Official title: A Pilot Study for a Self-Managed Intervention for Anxiety in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Anxiety
Keywords: Anxiety
Self-managed Intervention
Focused Breathing
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2019-03-01
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Mixed methods, 6 week randomized clinical trial. Using a block size of 4, a computer generated randomization schedule will be generated for an intervention arm and a waitlist arm.
Primary purpose: SUPPORTIVE_CARE

Brief summary: A mixed methods randomized controlled feasibility and acceptability study will be conducted to determine the effects of a self-managed, focused breathing intervention on anxiety in persons who have been diagnosed with Parkinson's disease.

Detailed description: This study is being conducted to determine the feasibility and acceptability of using focused breathing as a self managed, non-pharmacologic intervention for anxiety experienced by those with Parkinson's disease. Participants meeting eligibility criteria will be randomized to either an intervention or control group. Those in the intervention group will be taught how to perform focused breathing and asked to practice it twice daily for six weeks for a minimum of four minutes each time. Anxiety, depressive symptoms, sleep, self-efficacy and quality of life with be measured in participants in both the intervention group before beginning to practice focused breathing as well as in the control group. After six weeks of practice the same measurements will be collected from the intervention group. Additionally, intervention participants will participate in a brief interview at the end of their six weeks of practice. Control group participants will be taught how to perform focused breathing six weeks at the end of a six week wait-period, following collection of data using the aforementioned measures..

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Parkinson's disease
* Hoehn \& Yahr I, II, \& III
* Self report or clinical diagnosis of anxiety
* Ability to speak and read English

Exclusion Criteria:

* Montreal Cognitive Assessment scores less than 26, indicating cognitive impairment
* Persons under the age of 18 are excluded from this study

Primary outcomes:
measure: Parkinson Anxiety Scale (PAS)
timeFrame: 6 weeks following onset of focused breathing twice daily practice.
Secondary outcomes:
measure: Geriatric Depression Scale
timeFrame: 6 weeks
measure: Parkinson Sleep Scale - 2 (PSS-2)
timeFrame: 6 weeks
measure: General Self Efficacy Scale (GSES)
timeFrame: 6 weeks
measure: Parkinson's Quality Scale-8 (PDQ-8)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Jo Lynne Robins, PhD
role: PRINCIPAL_INVESTIGATOR
References: