- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New Jersey
-
Piscataway, New Jersey, United States, 08854
- Rutgers University Behavioral Healthcare
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Behavioral activation measured using the Behavioral Activation for Depression Scale (BADS)
Time Frame: 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
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Suicide-related cognitions measured using the Suicide Cognitions Scale (SCS)
Time Frame: 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
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro2025000588
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Suicide Ideation
-
Fundació Institut de Recerca de l'Hospital de la...Not yet recruitingSuicide | Suicide Risk | Suicide Attempt | Suicide Ideation | Suicide PreventionSpain
-
VA Office of Research and DevelopmentRecruitingSuicide Attempt | Suicide Ideation | Suicide PreventionUnited States
-
Vestre Viken Hospital TrustSouth-Eastern Norway Regional Health AuthorityActive, not recruitingEcological Momentary Assessment | Suicide Risk | Suicide Attempt | Suicide Ideation | Suicide PreventionNorway
-
University of Illinois at ChicagoNational Institute of Mental Health (NIMH)Enrolling by invitation
-
Northwestern UniversityNot yet recruitingSuicidal Ideation and Behavior
-
Hyung Keun ParkActive, not recruitingCognitive Behavioral Therapy | Suicide Attempt | Suicidal Ideation and BehaviorsSouth Korea
-
Shira BarzilaySchneider Children's Medical Center, IsraelRecruiting
-
Dartmouth-Hitchcock Medical CenterNational Institute of Nursing Research (NINR); Trustees of Dartmouth CollegeNot yet recruitingSuicide Attempt | Suicide IdeationUnited States
-
University of Sao PauloNot yet recruitingSuicide Ideation | Suicide Attempts
-
University of North Carolina, Chapel HillVillage Heartbeat, Inc.RecruitingSuicide | Suicide Attempt | Suicide Ideation | Suicide PreventionUnited States
Clinical Trials on Behavioral Activation
-
New York State Psychiatric InstituteCallen-Lorde Community Health CenterCompletedHIV Infection | FatigueUnited States
-
Hospital Miguel ServetCompletedMajor Depressive DisorderSpain
-
Medical University of South CarolinaNot yet recruiting
-
Medical University of South CarolinaNational Cancer Institute (NCI)Recruiting
-
Stanford UniversityCompletedDepression | Major Depressive Disorder | MDDUnited States
-
University of WashingtonNational Institute of Mental Health (NIMH)Completed
-
Central Arkansas Veterans Healthcare SystemNational Center for PTSDWithdrawn
-
Stanford UniversityCompletedDepression | Major Depressive Disorder | MDDUnited States
-
Seinajoki Central HospitalTampere UniversityCompletedAnxiety Disorders | Major Depression | Dual Diagnosis | Substance Related DisordersFinland
-
Northwestern UniversityCompletedDepression | Anhedonia | Bipolar DisorderUnited States