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Parkinson DiseaseNCT03859180

Self-Managed Intervention for Anxiety in Parkinson's Disease

A study testing Focused breathing in people with Parkinson Disease and Anxiety, run by Virginia Commonwealth University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Parkinson Disease, Anxiety
What is being tested?
Focused breathing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteUnited States
Study dates
15 Mar 2019to 11 Nov 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

Other trials in United States

About this study

Official title: A Pilot Study for a Self-Managed Intervention for Anxiety in Parkinson's Disease

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.

Read the 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..

Being tested
Focused breathing
Keywords
Anxiety, Self-managed Intervention, Focused Breathing
Medical subject headings
Parkinson Disease, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Focused breathingBehavioural

    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.

Study groups in NCT03859180
Study groupRoleWhat they receive
Focused breathing intervention groupExperimentalParticipants 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.
Receives: Behavioral: Focused breathing
Control groupNo interventionThe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 weeks following onset of focused breathing twice daily practice.

Secondary outcomes (4)

  1. Geriatric Depression Scale

    This is a 25 item, yes/no scale used to measure depressive symptoms. !1 point is scored for each bolded answer (see copy of tool). A score of 0-4 is considered normal; 5-8 suggests mild depressive symptoms; 8-1 moderate depressive symptoms, and 12-15 severe depressive symptoms. Scores of 5 or greater with will be communicated to the patient's Parkinson's provider. It will be administered pre and post intervention for the experimental group and pre and post enrollment for the control group.

    Measured: 6 weeks

  2. Parkinson Sleep Scale - 2 (PSS-2)

    This is 12 item Likert scale tool used to measure the experience and quality of sleep in individuals with Parkinson's disease. It is a 5 point scale ranging from 0 (very often) to 4 (never). three domains are measured: Motor symptoms at night, Parkinson's disease symptoms at night, and disturbed sleep. Each domain has 5 questions. Range of the domain scores is 0-20; total score range is 0-60. Participants are asked to answer the questions with referral to the past 7 days. Higher scores indicate greater nocturnal disturbance. It will be administered pre and post intervention for the experimental group and pre and post enrollment for the control group.

    Measured: 6 weeks

  3. General Self Efficacy Scale (GSES)

    This is a 10 question Likert style tool designed to measure self-efficacy, and has the following options:

    Not true at all (1 point) Hardly true (2 points) Moderately true (3 points) Exactly true.(4 points) Responses are made on a 4-point scale; final composite score range from 10 - 40. Higher scores reflect an optimistic self-belief that one can perform a novel or difficult task or cope with adversity. It will be administered pre and post intervention for the experimental group and pre and post enrollment for the control group.

    Measured: 6 weeks

  4. Parkinson's Quality Scale-8 (PDQ-8)

    This is an eight item Likert response tool designed to measure quality of life in those with Parkinson's disease and has the following options:

    Never Occasionally Sometimes Often Always or cannot do at all It will be administered pre and post intervention for the experimental group and pre and post enrollment for the control group. Answers of the eight items are summed; a score of 0 (0=never) indicates good health; as the score increases (maximum score is 1000 the higher the score the poorer health).

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Mar 2019
  2. Study start15 Mar 2019
  3. Primary completion11 Nov 2019
  4. Study completion11 Nov 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03859180
Sponsor's protocol ID
HM20014147
Status last verified
Jan 2020
First submitted
27 Feb 2019
Last updated
29 Jan 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Focused breathing in people with Parkinson Disease and Anxiety, run by Virginia Commonwealth University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Parkinson Anxiety Scale (PAS) (time frame: 6 weeks following onset of focused breathing twice daily practice.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03859180.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2020.

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