- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07611916
Supplementing Inpatient Behavioral Activation Group Psychotherapy
Supplementing Inpatient Group Psychotherapy
This study will evaluate the feasibility, acceptability, and preliminary effectiveness of a behavioral activation intervention designed for adults hospitalized on an inpatient psychiatric unit. The intervention includes two connected components: (1) a brief inpatient behavioral activation group delivered during hospitalization by unit staff (which is delivered to everyone as part of standard clinical care and not considered part of the study) and (2) a smartphone application that supports behavioral activation skills practice during the first 28 days after discharge.
Behavioral activation is a psychological treatment that aims to increase engagement in meaningful and rewarding activities and reduce patterns of avoidance that can worsen mental health symptoms. The intervention was designed specifically for the short length of stay and group-based structure typical of psychiatric inpatient care in the United States.
Participants will be recruited from an adult inpatient psychiatric unit at Rutgers University Behavioral Health Care.
The study uses an open trial design where there is no control group. Participants in the intervention condition will receive the behavioral activation group plus access to the smartphone application after discharge.
Participants will complete self-report assessments during hospitalization and throughout a 6-month follow-up period. During the first 28 days after discharge, participants will also complete smartphone-based ecological momentary assessments multiple times per day. Outcomes include depression, anxiety, suicidal thoughts and behaviors, functioning, behavioral activation, emergency department visits, psychiatric readmission, outpatient treatment engagement, and intervention feasibility and acceptability.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
The current study is a hybrid type I implementation-effectiveness trial evaluating a multimodal behavioral activation intervention for adults receiving inpatient psychiatric treatment. The intervention was developed to address two major gaps in acute psychiatric care in the United States: limited access to evidence-based psychotherapy during hospitalization and limited support during the transition from inpatient to outpatient care. The intervention combines a brief inpatient behavioral activation group delivered by unit staff as part of standard care during hospitalization, supplemented with a smartphone-based digital intervention designed to support behavioral activation skills practice during the first 28 days after discharge.
Behavioral activation is an evidence-based psychological treatment that seeks to increase engagement in adaptive and rewarding activities while reducing patterns of avoidance associated with emotional distress and psychiatric symptoms. The intervention was specifically adapted for the structure of contemporary inpatient psychiatric care in the United States, including short lengths of stay, high patient turnover, and reliance on group-based treatment delivered by multidisciplinary staff with varying levels of formal psychotherapy training. The intervention was also designed to be transdiagnostic and appropriate for patients with a range of psychiatric disorders commonly treated in inpatient settings.
The inpatient component is flexible but generally consists of four stand-alone behavioral activation group sessions focused on activity planning, values identification, problem-solving, and reducing avoidance behaviors. Sessions are designed so that patients may benefit regardless of admission timing or number of sessions attended. Following discharge, participants will use a smartphone application that includes ecological momentary assessment prompts, behavioral activation skill reminders, activity planning tools, activity monitoring, and access to psychoeducational materials consistent with the inpatient group content. The application is intended to support behavioral activation skill implementation during participants' transition back into their daily environments
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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New Jersey
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Piscataway, New Jersey, Stany Zjednoczone, 08854
- Rutgers University Behavioral Healthcare
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria: adult status (18+ years), admission to a hospital-based psychiatric inpatient service, the ability to speak and write English fluently, ownership of and consistent access to an internet-capable smartphone (e.g., an iPhone or Android phone).
Exclusion Criteria: the presence of any factor that impairs an individual's ability to provide informed consent and comprehend and effectively participate in the study including: an inability to speak or write English fluently, the presence of gross cognitive impairment due to florid psychosis, intellectual disability, dementia, acute intoxication, or the presence of extremely agitated or violent behavior.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: Treatment as usual (TAU) + ecological momentary intervention (EMI)
The intervention consists of a mobile app that allows skills practice after discharge, which maps on to the behavioral activation content delivered during the inpatient stay.
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This intervention has a mobile app that corresponds to the treatment received during the inpatient stay, which has not been done before.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Behavioral activation measured using the Behavioral Activation for Depression Scale (BADS)
Ramy czasowe: From enrollment until the end of the three-month follow-up period
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The Behavioral Activation for Depression Scale (BADS) is a self-report measure assessing engagement in goal-directed and rewarding activities, avoidance behaviors, and functional impairment associated with depression.
Scores on the activation subscale and total scale will be used to assess changes in behavioral activation over time.
Higher activation scores indicate greater engagement in adaptive activities, whereas higher avoidance scores indicate greater behavioral avoidance.
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From enrollment until the end of the three-month follow-up period
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Depressive symptoms measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Scale
Ramy czasowe: From enrollment until the end of the three-month follow-up period
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The PROMIS Depression Scale is a self-report measure assessing negative mood, decreased positive affect, and other symptoms associated with depression.
Scores are converted to standardized T-scores, with higher scores indicating greater depressive symptom severity.
Changes in PROMIS Depression scores across the follow-up period will be compared between study conditions.
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From enrollment until the end of the three-month follow-up period
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Suicide-related cognitions measured using the Suicide Cognitions Scale (SCS)
Ramy czasowe: From enrollment until the end of the three-month follow-up period
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The Suicide Cognitions Scale (SCS) is a self-report measure assessing maladaptive beliefs and cognitive patterns associated with suicide risk, including hopelessness, perceived burdensomeness, helplessness, and beliefs about emotional unchangeability.
Higher scores indicate greater endorsement of suicide-related cognitions associated with elevated suicide risk.
Changes in SCS scores over time will be compared between study conditions.
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From enrollment until the end of the three-month follow-up period
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Współpracownicy i badacze
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- Pro2025000588
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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