NCT07611916

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
10mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress15%
Apr 2026Apr 2027

Study Start

First participant enrolled

April 22, 2026

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

May 21, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 28, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Last Updated

May 28, 2026

Status Verified

May 1, 2026

Enrollment Period

6 months

First QC Date

May 21, 2026

Last Update Submit

May 21, 2026

Conditions

Keywords

ecological momentary interventionsuicidebehavioral activationdepressioninpatient

Outcome Measures

Primary Outcomes (2)

  • Behavioral activation measured using the Behavioral Activation for Depression Scale (BADS)

    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

    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 Outcomes (1)

  • Suicide-related cognitions measured using the Suicide Cognitions Scale (SCS)

    From enrollment until the end of the three-month follow-up period

Study Arms (1)

Treatment as usual (TAU) + ecological momentary intervention (EMI)

EXPERIMENTAL

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.

Behavioral: Behavioral Activation

Interventions

This intervention has a mobile app that corresponds to the treatment received during the inpatient stay, which has not been done before.

Treatment as usual (TAU) + ecological momentary intervention (EMI)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rutgers University Behavioral Healthcare

Piscataway, New Jersey, 08854, United States

Location

MeSH Terms

Conditions

Consciousness DisordersSuicideDepression

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersSelf-Injurious BehaviorBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Open pilot where all participants receive the study app.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 21, 2026

First Posted

May 28, 2026

Study Start

April 22, 2026

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

April 30, 2027

Last Updated

May 28, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Data are from a sensitive population.

Locations