- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03859180
Self-Managed Intervention for Anxiety in Parkinson's Disease
A Pilot Study for a Self-Managed Intervention for Anxiety in Parkinson's Disease
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Virginia
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Richmond, Virginia, Forenede Stater, 23298
- Virginia Commonwealth University
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 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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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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Ingen indgriben: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Parkinson Anxiety Scale (PAS)
Tidsramme: 6 weeks following onset of focused breathing twice daily practice.
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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.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Geriatric Depression Scale
Tidsramme: 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.
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6 weeks
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Parkinson Sleep Scale - 2 (PSS-2)
Tidsramme: 6 weeks
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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.
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6 weeks
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General Self Efficacy Scale (GSES)
Tidsramme: 6 weeks
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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. |
6 weeks
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Parkinson's Quality Scale-8 (PDQ-8)
Tidsramme: 6 weeks
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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). |
6 weeks
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Jo Lynne Robins, PhD, Virginia Commonwealth University
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- HM20014147
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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