Trial Outcomes & Findings for Reducing Suicide Risk in Adolescents and Young Adults Via a Psychobehavioral Intervention to Regularize Daily Rhythms (NCT NCT05317481)
NCT ID: NCT05317481
Last Updated: 2026-04-13
Results Overview
CHRT-SR is a validated, self-reported measure with a propensity subscore (9 items) identifying risk factors. Each item is scored on a five-point Likert scale with responses ranging from 0 ("Strongly disagree") to 4 ("Strongly agree"), thereby creating a total propensity score ranging from 0-36,with higher scores showing higher levels of suicidal propensity.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
65 participants
Primary outcome timeframe
Baseline (pre- intervention), 6 weeks (midpoint of intervention), 12 weeks (immediately after the intervention)
Results posted on
2026-04-13
Participant Flow
Participant milestones
| Measure |
BE-SMART-DR
Participation will include research clinical/behavioral interviews and symptom self-ratings, magnetic resonance imaging (MRI) scanning, actigraphy wearables, and use of smart phones for ecological momentary assessment (EMA). Subjects will participate in 12 weekly sessions and 6-month in person follow-up.
BE-SMART-DR: Therapy that provides self-directed strategies to regularize sleep and other DRs to reduce short-term suicide risk that can be used lifelong to potentially also reduce long-term suicide risk
|
Control Comparator Condition
Matched for experimental, participation will include research clinical/behavioral interviews and symptom self-ratings, magnetic resonance imaging (MRI) scanning, actigraphy wearables, and use of smart phones for ecological momentary assessment (EMA). Subjects will participate in 12 weekly sessions and 6-month in person follow-up.
psychoeducational control comparator condition (CC): Structured sessions, matched for BE-SMART-DR session number and time, that will emphasize established strategies to manage health and well being
|
|---|---|---|
|
Overall Study
STARTED
|
43
|
22
|
|
Overall Study
COMPLETED
|
30
|
17
|
|
Overall Study
NOT COMPLETED
|
13
|
5
|
Reasons for withdrawal
| Measure |
BE-SMART-DR
Participation will include research clinical/behavioral interviews and symptom self-ratings, magnetic resonance imaging (MRI) scanning, actigraphy wearables, and use of smart phones for ecological momentary assessment (EMA). Subjects will participate in 12 weekly sessions and 6-month in person follow-up.
BE-SMART-DR: Therapy that provides self-directed strategies to regularize sleep and other DRs to reduce short-term suicide risk that can be used lifelong to potentially also reduce long-term suicide risk
|
Control Comparator Condition
Matched for experimental, participation will include research clinical/behavioral interviews and symptom self-ratings, magnetic resonance imaging (MRI) scanning, actigraphy wearables, and use of smart phones for ecological momentary assessment (EMA). Subjects will participate in 12 weekly sessions and 6-month in person follow-up.
psychoeducational control comparator condition (CC): Structured sessions, matched for BE-SMART-DR session number and time, that will emphasize established strategies to manage health and well being
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
1
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Moved/Job or School Commitment Changes
|
6
|
0
|
|
Overall Study
Met Exclusion Criteria
|
0
|
1
|
|
Overall Study
Did not complete primary outcome assessments for the baseline visit
|
0
|
1
|
Baseline Characteristics
Reducing Suicide Risk in Adolescents and Young Adults Via a Psychobehavioral Intervention to Regularize Daily Rhythms
Baseline characteristics by cohort
| Measure |
BE-SMART-DR
n=43 Participants
Participation will include research clinical/behavioral interviews and symptom self-ratings, magnetic resonance imaging (MRI) scanning, actigraphy wearables, and use of smart phones for ecological momentary assessment (EMA). Subjects will participate in 12 weekly sessions and 6-month in person follow-up.
BE-SMART-DR: Therapy that provides self-directed strategies to regularize sleep and other DRs to reduce short-term suicide risk that can be used lifelong to potentially also reduce long-term suicide risk
|
Control Comparator Condition
n=22 Participants
Matched for experimental, participation will include research clinical/behavioral interviews and symptom self-ratings, magnetic resonance imaging (MRI) scanning, actigraphy wearables, and use of smart phones for ecological momentary assessment (EMA). Subjects will participate in 12 weekly sessions and 6-month in person follow-up.
psychoeducational control comparator condition (CC): Structured sessions, matched for BE-SMART-DR session number and time, that will emphasize established strategies to manage health and well being
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
3 Participants
n=193 Participants
|
3 Participants
n=193 Participants
|
6 Participants
n=386 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
40 Participants
n=193 Participants
|
19 Participants
n=193 Participants
|
59 Participants
n=386 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=193 Participants
|
20 Participants
n=193 Participants
|
50 Participants
n=386 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=193 Participants
|
2 Participants
n=193 Participants
|
15 Participants
n=386 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=193 Participants
|
4 Participants
n=193 Participants
|
8 Participants
n=386 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=193 Participants
|
18 Participants
n=193 Participants
|
57 Participants
n=386 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
3 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=193 Participants
|
2 Participants
n=193 Participants
|
4 Participants
n=386 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=193 Participants
|
19 Participants
n=193 Participants
|
55 Participants
n=386 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=193 Participants
|
1 Participants
n=193 Participants
|
3 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Region of Enrollment
United States
|
43 participants
n=193 Participants
|
22 participants
n=193 Participants
|
65 participants
n=386 Participants
|
PRIMARY outcome
Timeframe: Baseline (pre- intervention), 6 weeks (midpoint of intervention), 12 weeks (immediately after the intervention)Population: Adolescents and young adults with MDD or BD, at risk of suicide, and received BE-SMART-DR or the psychoeducational control condition (CC) and completed the CHRT-SR at baseline (pre-intervention), 6 weeks (midpoint of intervention), and 12 weeks (immediately after the intervention).
CHRT-SR is a validated, self-reported measure with a propensity subscore (9 items) identifying risk factors. Each item is scored on a five-point Likert scale with responses ranging from 0 ("Strongly disagree") to 4 ("Strongly agree"), thereby creating a total propensity score ranging from 0-36,with higher scores showing higher levels of suicidal propensity.
Outcome measures
| Measure |
BE-SMART-DR
n=30 Participants
Participation will include research clinical/behavioral interviews and symptom self-ratings, magnetic resonance imaging (MRI) scanning, actigraphy wearables, and use of smart phones for ecological momentary assessment (EMA). Subjects will participate in 12 weekly sessions and 6-month in person follow-up.
BE-SMART-DR: Therapy that provides self-directed strategies to regularize sleep and other DRs to reduce short-term suicide risk that can be used lifelong to potentially also reduce long-term suicide risk
|
Control Comparator Condition
n=17 Participants
Matched for experimental, participation will include research clinical/behavioral interviews and symptom self-ratings, magnetic resonance imaging (MRI) scanning, actigraphy wearables, and use of smart phones for ecological momentary assessment (EMA). Subjects will participate in 12 weekly sessions and 6-month in person follow-up.
psychoeducational control comparator condition (CC): Structured sessions, matched for BE-SMART-DR session number and time, that will emphasize established strategies to manage health and well being
|
|---|---|---|
|
Mean Score Measuring Suicidal Ideation/Propensity (SI/P) Using Concise Health Risk Tracking Scale-Self Reported (CHRT-SR) to Assess for Propensity
Baseline
|
12.83 score on a scale
Standard Error 1.08
|
12.41 score on a scale
Standard Error 1.44
|
|
Mean Score Measuring Suicidal Ideation/Propensity (SI/P) Using Concise Health Risk Tracking Scale-Self Reported (CHRT-SR) to Assess for Propensity
6 weeks
|
10.84 score on a scale
Standard Error 1.09
|
12.76 score on a scale
Standard Error 1.44
|
|
Mean Score Measuring Suicidal Ideation/Propensity (SI/P) Using Concise Health Risk Tracking Scale-Self Reported (CHRT-SR) to Assess for Propensity
12 weeks
|
9.20 score on a scale
Standard Error 1.08
|
10.29 score on a scale
Standard Error 1.44
|
PRIMARY outcome
Timeframe: Baseline (pre- intervention), 6 weeks (midpoint of intervention), 12 weeks (immediately after the intervention)Population: Adolescents and young adults with MDD or BD, at risk of suicide, and received BE-SMART-DR or the psychoeducational control condition (CC) and completed the Beck SSI at baseline (pre-intervention), 6 weeks (midpoint of intervention), and 12 weeks (immediately after the intervention).
Beck SSI is one of the most widely used measures to assess suicidal ideation. This nineteen item scale has scores ranging from 0 to 38, with higher values indicating a greater risk of suicide.
Outcome measures
| Measure |
BE-SMART-DR
n=30 Participants
Participation will include research clinical/behavioral interviews and symptom self-ratings, magnetic resonance imaging (MRI) scanning, actigraphy wearables, and use of smart phones for ecological momentary assessment (EMA). Subjects will participate in 12 weekly sessions and 6-month in person follow-up.
BE-SMART-DR: Therapy that provides self-directed strategies to regularize sleep and other DRs to reduce short-term suicide risk that can be used lifelong to potentially also reduce long-term suicide risk
|
Control Comparator Condition
n=17 Participants
Matched for experimental, participation will include research clinical/behavioral interviews and symptom self-ratings, magnetic resonance imaging (MRI) scanning, actigraphy wearables, and use of smart phones for ecological momentary assessment (EMA). Subjects will participate in 12 weekly sessions and 6-month in person follow-up.
psychoeducational control comparator condition (CC): Structured sessions, matched for BE-SMART-DR session number and time, that will emphasize established strategies to manage health and well being
|
|---|---|---|
|
Mean Score Measuring Suicidal Ideation/Propensity (SI/P) Using Beck Scale for Suicide Ideation (SSI) to Assess for Suicide Ideation.
Baseline
|
17.1 score on a scale
Standard Error 1.67
|
18.76 score on a scale
Standard Error 2.22
|
|
Mean Score Measuring Suicidal Ideation/Propensity (SI/P) Using Beck Scale for Suicide Ideation (SSI) to Assess for Suicide Ideation.
6 weeks
|
3.97 score on a scale
Standard Error 1.30
|
4.59 score on a scale
Standard Error 1.69
|
|
Mean Score Measuring Suicidal Ideation/Propensity (SI/P) Using Beck Scale for Suicide Ideation (SSI) to Assess for Suicide Ideation.
12 weeks
|
1.13 score on a scale
Standard Error 0.82
|
3.06 score on a scale
Standard Error 1.08
|
PRIMARY outcome
Timeframe: Baseline (pre- intervention), 6 weeks (midpoint of intervention), 12 weeks (immediately after the intervention)Population: Adolescents and young adults with MDD or BD, at risk for suicide, and received BE-SMART-DR or the psychoeducational control condition (CC) and completed the BSRS at baseline (pre-intervention), 6 weeks (midpoint of intervention), and 12 weeks (immediately after the intervention).
BSRS is a measure of DR regularity for 10 activities that include social contexts. It uses a scale ranging from 1 (very regularly) to 6 (very irregularly). Total scores range from 10 to 60, with higher scores indicating greater irregularity.
Outcome measures
| Measure |
BE-SMART-DR
n=30 Participants
Participation will include research clinical/behavioral interviews and symptom self-ratings, magnetic resonance imaging (MRI) scanning, actigraphy wearables, and use of smart phones for ecological momentary assessment (EMA). Subjects will participate in 12 weekly sessions and 6-month in person follow-up.
BE-SMART-DR: Therapy that provides self-directed strategies to regularize sleep and other DRs to reduce short-term suicide risk that can be used lifelong to potentially also reduce long-term suicide risk
|
Control Comparator Condition
n=17 Participants
Matched for experimental, participation will include research clinical/behavioral interviews and symptom self-ratings, magnetic resonance imaging (MRI) scanning, actigraphy wearables, and use of smart phones for ecological momentary assessment (EMA). Subjects will participate in 12 weekly sessions and 6-month in person follow-up.
psychoeducational control comparator condition (CC): Structured sessions, matched for BE-SMART-DR session number and time, that will emphasize established strategies to manage health and well being
|
|---|---|---|
|
Mean Score Measuring BE-SMART-DRs Daily Rhythms (DR) Using the Brief Social Rhythm Scale (BSRS)
Baseline
|
33.63 score on a scale
Standard Error 1.36
|
33.24 score on a scale
Standard Error 1.81
|
|
Mean Score Measuring BE-SMART-DRs Daily Rhythms (DR) Using the Brief Social Rhythm Scale (BSRS)
6 weeks
|
30.11 score on a scale
Standard Error 1.38
|
34.18 score on a scale
Standard Error 1.81
|
|
Mean Score Measuring BE-SMART-DRs Daily Rhythms (DR) Using the Brief Social Rhythm Scale (BSRS)
12 weeks
|
27.57 score on a scale
Standard Error 1.36
|
35.35 score on a scale
Standard Error 1.81
|
PRIMARY outcome
Timeframe: Baseline (pre-intervention), 6 weeks (midpoint of intervention), 12 weeks (immediately after the intervention)Population: Adolescents and young adults with MDD or BD, at risk for suicide, and received BE-SMART-DR or the psychoeducational control condition (CC) and completed the PSQI at baseline (pre-intervention), 6 weeks (midpoint of intervention), and 12 weeks (immediately after the intervention).
PSQI is a self reported questionnaire that assesses sleep quality over a 1 month period. It consists of seven component scores with each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21) with higher scores indicating worse sleep quality.
Outcome measures
| Measure |
BE-SMART-DR
n=30 Participants
Participation will include research clinical/behavioral interviews and symptom self-ratings, magnetic resonance imaging (MRI) scanning, actigraphy wearables, and use of smart phones for ecological momentary assessment (EMA). Subjects will participate in 12 weekly sessions and 6-month in person follow-up.
BE-SMART-DR: Therapy that provides self-directed strategies to regularize sleep and other DRs to reduce short-term suicide risk that can be used lifelong to potentially also reduce long-term suicide risk
|
Control Comparator Condition
n=17 Participants
Matched for experimental, participation will include research clinical/behavioral interviews and symptom self-ratings, magnetic resonance imaging (MRI) scanning, actigraphy wearables, and use of smart phones for ecological momentary assessment (EMA). Subjects will participate in 12 weekly sessions and 6-month in person follow-up.
psychoeducational control comparator condition (CC): Structured sessions, matched for BE-SMART-DR session number and time, that will emphasize established strategies to manage health and well being
|
|---|---|---|
|
Mean Score Measuring BE-SMART-DRs Daily Rhythms (DR) Using the Pittsburgh Sleep Quality Index (PSQI)
6 weeks
|
7.25 score on a scale
Standard Error 0.46
|
8.18 score on a scale
Standard Error 0.61
|
|
Mean Score Measuring BE-SMART-DRs Daily Rhythms (DR) Using the Pittsburgh Sleep Quality Index (PSQI)
12 weeks
|
6.27 score on a scale
Standard Error 0.50
|
7.65 score on a scale
Standard Error 0.67
|
|
Mean Score Measuring BE-SMART-DRs Daily Rhythms (DR) Using the Pittsburgh Sleep Quality Index (PSQI)
Baseline
|
7.53 score on a scale
Standard Error 0.65
|
7.94 score on a scale
Standard Error 0.86
|
Adverse Events
BE-SMART-DR
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Comparator Condition
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place