Self-Managed Intervention for Anxiety in Parkinson's Disease
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| ClinicalTrials.gov Identifier: NCT03859180 |
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Recruitment Status :
Recruiting
First Posted : March 1, 2019
Last Update Posted : April 4, 2019
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Parkinson Disease Anxiety | Behavioral: Focused breathing | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 60 participants |
| 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 |
| Official Title: | A Pilot Study for a Self-Managed Intervention for Anxiety in Parkinson's Disease |
| Actual Study Start Date : | March 15, 2019 |
| Estimated Primary Completion Date : | October 1, 2019 |
| Estimated Study Completion Date : | December 30, 2019 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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. |
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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.
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- 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.
- 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).
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03859180
| Contact: Susan K Chandler, MS | 804-828-1688 | skchandl@vcu.edu | |
| Contact: Jo Lynne Robins, PhD | jwrobins@vcu.edu |
| United States, Virginia | |
| Virginia Commonwealth University | Recruiting |
| Richmond, Virginia, United States, 23298 | |
| Principal Investigator: | Jo Lynne Robins, PhD | Virginia Commonwealth University |
| Responsible Party: | Virginia Commonwealth University |
| ClinicalTrials.gov Identifier: | NCT03859180 History of Changes |
| Other Study ID Numbers: |
HM20014147 |
| First Posted: | March 1, 2019 Key Record Dates |
| Last Update Posted: | April 4, 2019 |
| Last Verified: | April 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Keywords provided by Virginia Commonwealth University:
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Anxiety Self-managed Intervention Focused Breathing |
Additional relevant MeSH terms:
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Parkinson Disease Anxiety Disorders Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases Mental Disorders |