Self-Managed Intervention for Anxiety in Parkinson's Disease

NCT03859180 | Completed

• 1 other identifier: HM20014147
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Anxiety

Keywords

Anxiety; Self-managed Intervention; Focused Breathing

Outcome Measures

Primary Outcomes (1)

• Parkinson Anxiety Scale (PAS)

  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.

  6 weeks following onset of focused breathing twice daily practice.

Secondary Outcomes (4)

• Geriatric Depression Scale

  6 weeks

• Parkinson Sleep Scale - 2 (PSS-2)

  6 weeks

• General Self Efficacy Scale (GSES)

  6 weeks

• Parkinson's Quality Scale-8 (PDQ-8)

  6 weeks

Study Arms (2)

Focused breathing intervention group

EXPERIMENTAL

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.

Behavioral: Focused breathing

Control group

NO INTERVENTION

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.

Interventions

Focused breathing BEHAVIORAL

Focused breathing is a series of focused, controlled breaths that aid in relaxation. Each participation in this group will be taught how to do focused breathing by the study investigator. Once determined to be able to perform focused breathing, participants will be asked to practice it for 4 minutes, twice a day, for 6 weeks. If they choose to do so, they may practice focused breathing if they become anxious at other times. They will be asked to keep a diary of each time they practice and/or use focused breathing.

Focused breathing intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Anxiety Disorders

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Mental Disorders

Study Officials

• Jo Lynne Robins, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 27, 2019
• First Posted: March 1, 2019
• Study Start: March 15, 2019
• Primary Completion: November 11, 2019
• Study Completion: November 11, 2019
• Last Updated: January 29, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)