Förstärkande bensodiazepinreceptoragonist Beskrivning med akupunktur och yoga bland äldre vuxna
Förstärkande bensodiazepinreceptoragonist Beskrivning med akupunktur och yoga
The main purpose of this 12-week study is to see if a new combination of treatments can help older adults reduce benzodiazepine or related medication use. The treatment combination consists of 1) medical provider visits to gradually reduce the medication dose over 12 weeks, 2) acupuncture treatments, and 3) private yoga classes. Participants will be offered weekly visits for 12 weeks to receive combined treatments. Participants will be provided surveys before, during, and after the study to learn about their experience of the treatments. At the end of the study, participants will be invited to participate in a focus group to learn about their experience in the study.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
This study consists of a single-arm clinical study among 30 older adults taking benzodiazepine receptor antagonists (BRZA) to assess the feasibility of protocol-driven BRZA deprescribing augmented with combined acupuncture and yoga. Adults 65 years or older that are taking BRZA will be recruited. Deprescribing will be provided at weekly visits with a psychiatric nurse practitioner at the Osher Center for Integrative Health at Vanderbilt University Medical Center. Participants will receive acupuncture and yoga from a staff acupuncturist and yoga instruction from a yoga instructor at the Osher Center. Feasibility of study enrollment will occur through the study enrollment period. Feasibility of study treatments will be evaluated during and after study treatment delivery. Feasibility of study outcome assessments will occur at baseline, 4, 8, and 12 weeks. Throughout the research process, investigators will engage a Stakeholder Advisory Panel consisting of patients and clinicians.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Tennessee
-
Nashville, Tennessee, Förenta staterna, 37203
- Osher Center for Integrative Health at Vanderbilt
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- 65 years and older
- Taking benzodiazepines or related medications (i.e. zolpidem, zopiclone, eszopiclone, zaleplon) at least 4 times in the last month
- English speaking
- Ability to understand study procedures and to comply with them for the length of the study
Exclusion Criteria:
- Cognitive impairment
- Drinking more than 3 alcoholic beverages per day
- Substance abuse disorder
- Uncontrolled psychiatric disorder, such as major depression or psychosis
- Inability or unwillingness of individual or legal guardian.representative to give written informed consent.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Feasibility, Adherence and Acceptability Measure
Assay of feasibility of study enrollment and feasibility of study treatments, the latter of which is measured via fidelity, adherence, and acceptability of/to treatments and interventions. Interventions administered for 12 weeks. Fidelity, adherence, and acceptability will be measured via patient survey and engagement. |
Patients will receive acupuncture for 12 weeks. Patients will receive yoga therapy with one of three yoga instructors. Patients will remain with singular yoga instructor for duration of study. It is anticipated that patients will participate in yoga therapy for 12 weeks at home and in-clinic. Deprescribing of patients' benzodiazepine use will be monitored by psychiatric nurse. Tapering method will be followed for medication deprescription. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
BRZA Dose Change
Tidsram: Baseline to 12 weeks
|
Dose of BRZA for patients will be measured at baseline and 12 weeks |
Baseline to 12 weeks
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Insomnia
Tidsram: Baseline to12 weeks
|
Will use Patient Reported Outcomes Measurement Information System(PROMIS) Sleep Disturbance Computerized Adaptive Testing to assess difficulties staying and falling asleep. The minimum value is 0 and the maximum value is 100, with higher scores determining worse outcomes. |
Baseline to12 weeks
|
|
Anxiety
Tidsram: Baseline to 12 weeks
|
Will use Patient Reported Outcomes Measurement Information System(PROMIS) Anxiety Computerized Adaptive Testing. The minimum value is 0 and the maximum value is 100, with higher scores determining worse outcomes. |
Baseline to 12 weeks
|
|
Proportion of Participants Whom the Investigators Collect Primary and Secondary Outcomes.
Tidsram: Baseline to 12 weeks
|
Will estimate feasibility of data collection for study measures by calculating proportion of participants whom the investigators collect primary and secondary outcomes. |
Baseline to 12 weeks
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Gurjeet Birdee, Vanderbilt University Medical Center
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Sjukdomar i nervsystemet
- Mentala störningar
- Vakna sömnstörningar
- Sömnstörningar, inneboende
- Dyssomni
- Ångeststörningar
- Sömninitiering och underhållsstörningar
- Terapeutik
- Narkotikabehandling
- Mind-body terapier
- Kompletterande behandlingar
- Andlig terapi
- Träningstekniker
- Fysioterapimetoder
- Yoga
- Akupunkturterapi
- Departementen
Andra studie-ID-nummer
- 230716
- R24AG064025 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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