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Supplementing Inpatient Behavioral Activation Group Psychotherapy

21 de mayo de 2026 actualizado por: Evan M. Kleiman, Ph.D., Rutgers, The State University of New Jersey

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.

Descripción general del estudio

Estado

Inscripción por invitación

Intervención / Tratamiento

Descripción detallada

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

Tipo de estudio

Intervencionista

Inscripción (Estimado)

30

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • New Jersey
      • Piscataway, New Jersey, Estados Unidos, 08854
        • Rutgers University Behavioral Healthcare

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
This intervention has a mobile app that corresponds to the treatment received during the inpatient stay, which has not been done before.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Behavioral activation measured using the Behavioral Activation for Depression Scale (BADS)
Periodo de tiempo: From enrollment until the end of the three-month follow-up period
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.
From enrollment until the end of the three-month follow-up period
Depressive symptoms measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Scale
Periodo de tiempo: From enrollment until the end of the three-month follow-up period
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.
From enrollment until the end of the three-month follow-up period

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Suicide-related cognitions measured using the Suicide Cognitions Scale (SCS)
Periodo de tiempo: From enrollment until the end of the three-month follow-up period
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.
From enrollment until the end of the three-month follow-up period

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

22 de abril de 2026

Finalización primaria (Estimado)

31 de octubre de 2026

Finalización del estudio (Estimado)

30 de abril de 2027

Fechas de registro del estudio

Enviado por primera vez

21 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

21 de mayo de 2026

Publicado por primera vez (Actual)

28 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

28 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

21 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

Data are from a sensitive population.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre Behavioral Activation

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