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Self-Managed Intervention for Anxiety in Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03859180
Recruitment Status : Completed
First Posted : March 1, 2019
Last Update Posted : January 29, 2020
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

Tracking Information
First Submitted Date  ICMJE February 27, 2019
First Posted Date  ICMJE March 1, 2019
Last Update Posted Date January 29, 2020
Actual Study Start Date  ICMJE March 15, 2019
Actual Primary Completion Date November 11, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 25, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 27, 2019)
Parkinson Anxiety Scale (PAS) [ Time Frame: 6 weeks following onset of focused breathing twice daily practice. ]
This is an 11 question, Likert scale tool designed to measure anxiety 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 25, 2019)
  • Geriatric Depression Scale [ Time Frame: 6 weeks ]
    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.
  • Parkinson Sleep Scale - 2 (PSS-2) [ Time Frame: 6 weeks ]
    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.
  • General Self Efficacy Scale (GSES) [ Time Frame: 6 weeks ]
    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.
  • Parkinson's Quality Scale-8 (PDQ-8) [ Time Frame: 6 weeks ]
    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).
Original Secondary Outcome Measures  ICMJE
 (submitted: February 27, 2019)
  • Geriatric Depression Scale [ Time Frame: 6 weeks ]
    This is a 25 item, yes/no scale used to measure depressive symptoms. It will be administered pre and post intervention for the experimental group and pre and post enrollment for the control group.
  • Parkinson Sleep Scale - 2 (PSS-2) [ Time Frame: 6 weeks ]
    This is 12 item Likert scale tool used to measure the experience and quality of sleep in individuals with Parkinson's disease. It will be administered pre and post intervention for the experimental group and pre and post enrollment for the control group.
  • General Self Efficacy Scale (GSES) [ Time Frame: 6 weeks ]
    This is a 10 question Likert style tool designed to measure self-efficacy. It will be administered pre and post intervention for the experimental group and pre and post enrollment for the control group.
  • Parkinson's Quality Scale-8 (PDQ-8) [ Time Frame: 6 weeks ]
    This is an eight item Likert response tool designed to measure quality of life in those with Parkinson's disease. It will be administered pre and post intervention for the experimental group and pre and post enrollment for the control group.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Self-Managed Intervention for Anxiety in Parkinson's Disease
Official Title  ICMJE A Pilot Study for a Self-Managed Intervention for Anxiety in Parkinson's Disease
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
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.
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.
Primary Purpose: Supportive Care
Condition  ICMJE
  • Parkinson Disease
  • Anxiety
Intervention  ICMJE Behavioral: Focused breathing
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 Arms  ICMJE
  • Experimental: 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: Behavioral: Focused breathing
  • No Intervention: 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 28, 2020)
28
Original Estimated Enrollment  ICMJE
 (submitted: February 27, 2019)
60
Actual Study Completion Date  ICMJE November 11, 2019
Actual Primary Completion Date November 11, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03859180
Other Study ID Numbers  ICMJE HM20014147
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Virginia Commonwealth University
Study Sponsor  ICMJE Virginia Commonwealth University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jo Lynne Robins, PhD Virginia Commonwealth University
PRS Account Virginia Commonwealth University
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP