Self-Managed Intervention for Anxiety in Parkinson's Disease

Virginia Commonwealth University (VCU)

Status: Completed

Conditions: Parkinson Disease; Anxiety

Treatments: Behavioral: Focused breathing

Study type: Interventional

Funder types: Other

Identifiers

NCT03859180

HM20014147

Details and patient eligibility

About

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.

Full 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..

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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28 participants in 2 patient groups

Focused breathing intervention group

Experimental group

Description:

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.

Treatment:

Behavioral: Focused breathing

Control group

No Intervention group

Description:

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.