Wywiady motywacyjne w celu ograniczenia używania substancji wśród pacjentów z depresją
8 czerwca 2015 zaktualizowane przez: University of California, San Francisco
Badanie ma na celu ocenę skuteczności interwencji mającej na celu ograniczenie używania alkoholu i narkotyków oraz objawów depresji, poprawę stanu funkcjonalnego i promowanie odpowiedniego korzystania z usług zdrowotnych na próbie 300 dorosłych szukających leczenia depresji, którzy zgłaszają również ryzykowne picie lub używanie narkotyków z depresją .
Przegląd badań
Status
Zakończony
Interwencja / Leczenie
Szczegółowy opis
Niniejsze badanie odpowiada na ważne pytania dotyczące identyfikacji i leczenia pacjentów w psychiatrii, którzy zgłaszają się na usługi z powodu używania alkoholu lub narkotyków, które mogą zaostrzyć depresję.
Badacze proponują badanie krótkiej interwencji motywacyjnej (BMI) w celu ograniczenia używania narkotyków i alkoholu wśród pacjentów z depresją oraz w razie potrzeby zwiększenia zaangażowania w program odzyskiwania uzależnienia chemicznego Kaiser (CDRP).
Pacjenci z depresją, którzy używają narkotyków lub alkoholu nawet na poziomie subdiagnostycznym, są narażeni na wysokie ryzyko eskalacji problemów związanych z substancjami.
BMI to innowacyjne, oparte na dowodach podejście, które może zmniejszyć spożycie narkotyków i alkoholu oraz poprawić wyniki.
Ale nie został przetestowany wśród pacjentów z depresją.
Ta próba badawcza obejmie 300 pacjentów ambulatoryjnych leczonych z powodu depresji w Kaiser Permanente Northern California Hayward/Fremont Psychiatry.
Kryteria włączenia opierają się na używaniu narkotyków (wszelkie nielegalne zażywanie narkotyków i stosowanie leków na receptę bez recepty) i piciu niebezpiecznym (tj. ≥ 3 drinki dziennie dla kobiet i ≥ 4 drinki dziennie dla mężczyzn) oraz umiarkowane do ciężkiego objawy depresji przy przyjęciu.
Trzysta pacjentów zostanie losowo przydzielonych do jednej osobistej sesji BMI i dwóch telefonicznych sesji BMI w ciągu 6 tygodni od przyjęcia (interwencja) lub broszury na temat ryzyka związanego z używaniem narkotyków i alkoholu (kontrola).
Badacze przewidują, że interwencja będzie skuteczna w zmniejszaniu częstości używania narkotyków i picia ryzykownego podczas 3-, 6- i 12-miesięcznych rozmów telefonicznych; poprawa nastroju i wyników funkcjonalnych; zwiększenie retencji w leczeniu depresji (liczba wizyt w poradniach psychiatrycznych na podstawie standardów HEDIS dotyczących efektywności opieki zdrowotnej); oraz ułatwienie pacjentowi rozpoczęcia programu leczenia uzależnienia chemicznego, jeśli zajdzie taka potrzeba, i będzie to opłacalne.
W celu poprawy opieki nad pacjentem, dostarczy również ważnych informacji na temat integracji interwencji alkoholowych i narkotykowych w psychiatrii oraz jak najlepiej pomóc pacjentom w razie potrzeby uzyskać dostęp do specjalistycznych usług CDRP.
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
307
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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California
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Union City, California, Stany Zjednoczone, 94545
- Kaiser Permanente Medical Center Southern Alameda County
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat i starsze (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
Kryteria przyjęcia:
- Picie niebezpieczne (tj. ≥ 3 drinki dziennie dla kobiet i ≥ 4 drinki dziennie dla mężczyzn)
- Używanie narkotyków (w tym wszelkie nielegalne używanie narkotyków i stosowanie leków na receptę bez recepty w ciągu ostatnich 30 dni)
- Umiarkowane lub nasilone objawy depresji na podstawie wyniku ≥ 5 w Kwestionariuszu Zdrowia Pacjenta (PHQ-9)
Kryteria wyłączenia:
- Obecna mania lub psychoza
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Badania usług zdrowotnych
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: Wywiady motywacyjne
Interwencja wywiadu motywacyjnego (MI) składała się z jednej 45-minutowej sesji MI, po której następowały dwie 15-minutowe sesje telefoniczne „wzmacniające”
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Aktywny komparator: Kontrola
Uczestnicy otrzymali broszurę na temat zagrożeń związanych z używaniem alkoholu i narkotyków.
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Uczestnicy otrzymali broszurę na temat zagrożeń związanych z używaniem alkoholu i narkotyków.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Niebezpieczne picie w ciągu ostatnich 30 dni (zgłoszona przez samych siebie liczba dni niebezpiecznego picia)
Ramy czasowe: 6 miesięcy
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Zgłoszona przez samych siebie liczba dni picia niebezpiecznego (3+ drinki dziennie dla kobiet / 4+ drinki dziennie dla mężczyzn) w ciągu ostatnich 30 dni.
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6 miesięcy
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Zażywanie narkotyków w ciągu ostatnich 30 dni (liczba dni używania narkotyków podana przez respondentów)
Ramy czasowe: 6 miesięcy
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Zgłoszona przez siebie liczba dni zażywania narkotyków (nielegalnego lub niewłaściwego stosowania leków na receptę) w ciągu ostatnich 30 dni.
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6 miesięcy
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Niebezpieczne picie w ciągu ostatnich 30 dni (zgłoszona przez samych siebie liczba dni niebezpiecznego picia)
Ramy czasowe: 12 miesięcy
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Zgłoszona przez samych siebie liczba dni picia niebezpiecznego (3+ drinki dziennie dla kobiet / 4+ drinki dziennie dla mężczyzn) w ciągu ostatnich 30 dni.
Badamy zmianę między stosowaniem po 6 miesiącach a stosowaniem po 12 miesiącach, aby zmierzyć długoterminowy wpływ interwencji.
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12 miesięcy
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Zażywanie narkotyków w ciągu ostatnich 30 dni (liczba dni używania narkotyków podana przez respondentów)
Ramy czasowe: 12 miesięcy
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Zgłoszona przez siebie liczba dni zażywania narkotyków (nielegalnego lub niewłaściwego stosowania leków na receptę) w ciągu ostatnich 30 dni.
Badamy zmianę użytkowania między 6 a 12 miesiącami, aby zmierzyć długoterminowy wpływ interwencji.
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12 miesięcy
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Objawy depresji (wynik kwestionariusza zdrowia pacjenta (PHQ-9))
Ramy czasowe: 12 miesięcy
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mierzone podczas wywiadów telefonicznych. PHQ-9 ocenia częstość występowania 9 rodzajów problemów w ciągu ostatnich 2 tygodni; odpowiedzi wahają się od 0 (wcale) do 3 (prawie codziennie).
Jeśli co najmniej 4 z 9 są >0, suma wyników pozycji jest używana do wskazania nasilenia depresji: 1-4 Minimalna; 5-9 Łagodny; 10-14 Umiarkowane; 15-19 Umiarkowanie ciężki; 20-27 Ciężkie.
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12 miesięcy
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Odpowiednie leczenie w zakresie zdrowia psychicznego (liczba uczestników otrzymujących nieprzerwane 12-tygodniowe leczenie w Przychodni Psychiatrycznej Kaiser Permanente)
Ramy czasowe: 3 miesiące
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Liczba uczestników otrzymujących nieprzerwane 12-tygodniowe leczenie w Oddziale Psychiatrycznym Kaiser Permanente
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3 miesiące
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Współpracownicy
Śledczy
- Główny śledczy: Derek D Satre, PhD, University of California, San Francisco
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
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Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 października 2010
Zakończenie podstawowe (Rzeczywisty)
1 sierpnia 2014
Ukończenie studiów (Rzeczywisty)
1 sierpnia 2014
Daty rejestracji na studia
Pierwszy przesłany
7 kwietnia 2015
Pierwszy przesłany, który spełnia kryteria kontroli jakości
17 kwietnia 2015
Pierwszy wysłany (Oszacować)
20 kwietnia 2015
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
10 czerwca 2015
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
8 czerwca 2015
Ostatnia weryfikacja
1 czerwca 2015
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 10-03323
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
Badania kliniczne na Zaburzenia związane z substancjami
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University of Michigan Rogel Cancer CenterNational Cancer Institute (NCI)Jeszcze nie rekrutacjaSyndrom Lyncha | Dziedziczny zespół nowotworowy | BRCA1-Related Hereditary Breast and Ovarian Cancer Syndrome | BRCA2-Related Hereditary Breast and Ovarian Cancer SyndromeStany Zjednoczone