Suicide IdeationNCT07611916
Supplementing Inpatient Behavioral Activation Group Psychotherapy
A study testing Behavioral Activation in people with Suicide Ideation and Depressed, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide Ideation, Depressed
- What is being tested?
- Behavioral Activation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2026to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Rutgers University Behavioral Healthcare
Piscataway, New Jersey, 08854
About this study
Official title: 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.
Read more
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.
Read the 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
- Conditions
- Suicide Ideation, Depressed
- Being tested
- Behavioral Activation
- Keywords
- ecological momentary intervention, suicide, behavioral activation, depression, inpatient
- Medical subject headings
- Consciousness Disorders, Suicide, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral ActivationBehavioural
This intervention has a mobile app that corresponds to the treatment received during the inpatient stay, which has not been done before.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Behavioral Activation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
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.
Measured: From enrollment until the end of the three-month follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start22 Apr 2026
- Primary completion31 Oct 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicide IdeationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open pilot where all participants receive the study app.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evan M. Kleiman, Ph.D., Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07611916
- Sponsor's protocol ID
- Pro2025000588
- Status last verified
- Jul 2026
- First submitted
- 21 May 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data are from a sensitive population.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supplementing Inpatient Group Psychotherapy
- ClinicalTrials.gov ID
- NCT07611916
- Acronym / sponsor ID
- Pro2025000588
- Conditions
- Suicide Ideation, Depressed
- Keywords
- ecological momentary intervention, suicide, behavioral activation, depression, inpatient
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 22 Apr 2026 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 28 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open pilot where all participants receive the study app.
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual (TAU) + ecological momentary intervention (EMI) | Experimental | Behavioral: Behavioral ActivationThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral ActivationThis intervention has a mobile app that corresponds to the treatment received during the inpatient stay, which has not been done before. | Behavioural | Treatment as usual (TAU) + ecological momentary intervention (EMI) |
Primary outcome
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.
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.
1 secondary outcome
Suicide-related cognitions measured using the Suicide Cognitions Scale (SCS)
Time frame: From enrollment until the end of the three-month follow-up period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: No. Data are from a sensitive population.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Activation in people with Suicide Ideation and Depressed, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.