A Pilot Study for a Self-Managed Intervention for Anxiety in Parkinson's Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Parkinson Anxiety Scale (PAS)
Study Overview
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..
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Masking Description
Assistant performing data checks will mask the random assignments; written on index cards and sealed in security envelope. Opened following informed consent signature obtained and time one outcome measures completed.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Focused breathing intervention group
Participants randomized to this group will be taught how to perform focused breathing for the self-management of anxiety and asked to practice for 4 minutes each day during a six week period. They may practice focused breathing in addition to the twice daily practices if they experience anxiety. They will be asked to document in a diary each time they practice focused breathing.
Intervention: Focused breathing (Behavioral)
Control group
The participants randomized to this group with not be required to perform any additional behaviors for the six week period of the study. After completing post-tests they will be taught how to perform focused breathing for the self-management of anxiety.
Outcomes
Primary Outcomes
Parkinson Anxiety Scale (PAS)
Time Frame: 6 weeks following onset of focused breathing twice daily practice.
This is an 11 question, Likert scale which includes the following responses: Not at all or never Very mild or rarely Mild, or sometimes Moderate, or often Severe, or (nearly) always. The tool is has 3 sub-scales designed to measure persistent anxiety, episodic anxiety, and avoidance behavior in Parkinson's disease. It will be administered pre and post intervention for the experimental group and pre and post enrollment for the control group. Scores from 36-48 could indicate the possibility of an anxiety disorder and the need for a clinical evaluation.
Secondary Outcomes
- Parkinson's Quality Scale-8 (PDQ-8)(6 weeks)
- General Self Efficacy Scale (GSES)(6 weeks)
- Geriatric Depression Scale(6 weeks)
- Parkinson Sleep Scale - 2 (PSS-2)(6 weeks)