Trial Outcomes & Findings for Text-Message-Based Depression Prevention for High-Risk Youth in the ED (NCT NCT02332239)
NCT ID: NCT02332239
Last Updated: 2020-02-05
Results Overview
Becks Depression Inventory (BDI-2): To analyze changes in past-two-week depressive symptoms in iDOVE participants, relative to an automated health-and-safety brief intervention and text message program. The Beck Depression Inventory (BDI-2) is a 1996 revision of the BDI, developed in response to the Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV, which changed many of the diagnostic criteria for Major Depressive Disorder. Participants were asked to rate how they have been feeling for the past two weeks. It contains 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms. The standardized cutoffs used differ from the original: 0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression; 29-63: severe depression.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
116 participants
Primary outcome timeframe
Enrollment, 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment (8 wks after close of intervention)
Results posted on
2020-02-05
Participant Flow
Of 1,190 potential screening subjects presenting to the ED for any reason during from February-December 2015, 1063 consented to screening. Of these, 1031 were successfully screened and 142 met eligibility criteria for the full trial. Of those eligible for the full randomized controlled trial (RCT), 116 consented.
Participant milestones
| Measure |
iDOVE Intervention (ED+Text)
1. In-ED brief session, introducing basic principles of cognitive behavioral theory and the structure of the text-message portion of the intervention
2. Eight-week longitudinal tailored CBT-based text-message program
iDOVE Intervention (ED+text): 1) In-ED brief session, introducing basic principles of cognitive behavioral theory and the structure of the text-message portion of the intervention 2) Eight-week longitudinal tailored text-message program
|
Control (EUC)
1. In-ED brief session, discussing home safety \& nutrition
2. Eight-week longitudinal home safety \& nutrition text-message program
Control (EUC): 1) In-ED brief session, discussing home safety \& nutrition 2) Eight-week longitudinal home safety \& nutrition text-message program
|
|---|---|---|
|
Overall Study
STARTED
|
58
|
58
|
|
Overall Study
COMPLETED
|
54
|
52
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
Reasons for withdrawal
| Measure |
iDOVE Intervention (ED+Text)
1. In-ED brief session, introducing basic principles of cognitive behavioral theory and the structure of the text-message portion of the intervention
2. Eight-week longitudinal tailored CBT-based text-message program
iDOVE Intervention (ED+text): 1) In-ED brief session, introducing basic principles of cognitive behavioral theory and the structure of the text-message portion of the intervention 2) Eight-week longitudinal tailored text-message program
|
Control (EUC)
1. In-ED brief session, discussing home safety \& nutrition
2. Eight-week longitudinal home safety \& nutrition text-message program
Control (EUC): 1) In-ED brief session, discussing home safety \& nutrition 2) Eight-week longitudinal home safety \& nutrition text-message program
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
6
|
Baseline Characteristics
Text-Message-Based Depression Prevention for High-Risk Youth in the ED
Baseline characteristics by cohort
| Measure |
iDOVE Intervention (ED+Text)
n=58 Participants
1. In-ED brief session, introducing basic principles of cognitive behavioral theory and the structure of the text-message portion of the intervention
2. Eight-week longitudinal tailored CBT-based text-message program
iDOVE Intervention (ED+text): 1) In-ED brief session, introducing basic principles of cognitive behavioral theory and the structure of the text-message portion of the intervention 2) Eight-week longitudinal tailored text-message program
|
Control (EUC)
n=58 Participants
1. In-ED brief session, discussing home safety \& nutrition
2. Eight-week longitudinal home safety \& nutrition text-message program
Control (EUC): 1) In-ED brief session, discussing home safety \& nutrition 2) Eight-week longitudinal home safety \& nutrition text-message program
|
Total
n=116 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
14.83 years
STANDARD_DEVIATION 1.23 • n=5 Participants
|
15.05 years
STANDARD_DEVIATION 1.13 • n=7 Participants
|
14.94 years
STANDARD_DEVIATION 1.18 • n=5 Participants
|
|
Sex/Gender, Customized
Gender · Female
|
34 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender · Male
|
24 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender · Transgender, Other, Prefer not to answer
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
58 participants
n=5 Participants
|
58 participants
n=7 Participants
|
116 participants
n=5 Participants
|
|
School Year
Grades 6-8
|
16 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
School Year
Grades 9-12
|
37 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
School Year
College
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
School Year
Not in school
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Socio-economic status
Low SES
|
36 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Socio-economic status
High SES
|
20 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Socio-economic status
Prefer not to answer
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sexual Orientation
Straight
|
43 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Sexual Orientation
LGBQ
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sexual Orientation
Prefer not to answer
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
The Revised Conflict Tactics Scales (CTS-2)
|
5.07 units on a scale
STANDARD_DEVIATION 6.72 • n=5 Participants
|
2.69 units on a scale
STANDARD_DEVIATION 2.64 • n=7 Participants
|
3.88 units on a scale
STANDARD_DEVIATION 5.22 • n=5 Participants
|
|
The Patient Health Questionnaire (PHQ-9)
|
9.43 units on a scale
STANDARD_DEVIATION 3.82 • n=5 Participants
|
8.78 units on a scale
STANDARD_DEVIATION 3.49 • n=7 Participants
|
9.10 units on a scale
STANDARD_DEVIATION 3.66 • n=5 Participants
|
|
The Beck Depression Inventory (BDI-2)
|
13.60 units on a scale
STANDARD_DEVIATION 8.59 • n=5 Participants
|
13.41 units on a scale
STANDARD_DEVIATION 10.10 • n=7 Participants
|
13.51 units on a scale
STANDARD_DEVIATION 9.33 • n=5 Participants
|
PRIMARY outcome
Timeframe: Enrollment, 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment (8 wks after close of intervention)Population: Stratified by baseline "moderate depressive symptoms" (BDI\>=20).
Becks Depression Inventory (BDI-2): To analyze changes in past-two-week depressive symptoms in iDOVE participants, relative to an automated health-and-safety brief intervention and text message program. The Beck Depression Inventory (BDI-2) is a 1996 revision of the BDI, developed in response to the Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV, which changed many of the diagnostic criteria for Major Depressive Disorder. Participants were asked to rate how they have been feeling for the past two weeks. It contains 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms. The standardized cutoffs used differ from the original: 0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression; 29-63: severe depression.
Outcome measures
| Measure |
iDOVE Intervention (ED+Text)
n=58 Participants
1. In-ED brief session, introducing basic principles of cognitive behavioral theory (CBT) and the structure of the text-message portion of the intervention
2. Eight-week longitudinal tailored CBT-based text-message program
iDOVE Intervention (ED+text): 1) In-ED brief session, introducing basic principles of cognitive behavioral theory (CBT) and the structure of the text-message portion of the intervention 2) Eight-week longitudinal tailored text-message program
|
Control (EUC)
n=58 Participants
1. In-ED brief session, discussing home safety \& nutrition
2. Eight-week longitudinal home safety \& nutrition text-message program
Control (Enhanced Usual Care (EUC)): 1) In-ED brief session, discussing home safety \& nutrition 2) Eight-week longitudinal home safety \& nutrition text-message program
|
|---|---|---|
|
Change in Depressive Symptoms
BDI Score: 16 week
|
12.5 units on a scale
Standard Deviation 12.8
|
11.7 units on a scale
Standard Deviation 11.0
|
|
Change in Depressive Symptoms
BDI Score where baseline >=20: Baseline
|
24.5 units on a scale
Standard Deviation 4.2
|
27.9 units on a scale
Standard Deviation 9.2
|
|
Change in Depressive Symptoms
BDI Score where baseline >=20: 8 week
|
19.9 units on a scale
Standard Deviation 12.1
|
27.2 units on a scale
Standard Deviation 11.5
|
|
Change in Depressive Symptoms
BDI Score where baseline >=20: 16 week
|
21.9 units on a scale
Standard Deviation 14.9
|
25.2 units on a scale
Standard Deviation 10.0
|
|
Change in Depressive Symptoms
BDI Score: Baseline
|
13.6 units on a scale
Standard Deviation 8.6
|
13.4 units on a scale
Standard Deviation 10.1
|
|
Change in Depressive Symptoms
BDI Score: 8 week
|
14.8 units on a scale
Standard Deviation 12.4
|
15.0 units on a scale
Standard Deviation 11.9
|
PRIMARY outcome
Timeframe: Enrollment, 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment (8 wks after close of intervention)Population: Stratified by higher baseline violence (CTS score \>=4)
The Physical Assault subscale of the Conflict Tactics Scale (CTS-2), developed by Straus et al. (1996), was used to analyze changes in past-two-month peer violence in iDOVE participants, relative to an automated health-and-safety brief intervention and text message program. There are 14 items that measure violent behavior, each scored based on how frequently the participant has experienced the behavior (0=never to 6=20+ times). Score is summed, so the minimum score possible is 14\*0=0 (lowest level of violence) and the maximum score possible is 14\*6=84 (highest level of violence).
Outcome measures
| Measure |
iDOVE Intervention (ED+Text)
n=58 Participants
1. In-ED brief session, introducing basic principles of cognitive behavioral theory (CBT) and the structure of the text-message portion of the intervention
2. Eight-week longitudinal tailored CBT-based text-message program
iDOVE Intervention (ED+text): 1) In-ED brief session, introducing basic principles of cognitive behavioral theory (CBT) and the structure of the text-message portion of the intervention 2) Eight-week longitudinal tailored text-message program
|
Control (EUC)
n=58 Participants
1. In-ED brief session, discussing home safety \& nutrition
2. Eight-week longitudinal home safety \& nutrition text-message program
Control (Enhanced Usual Care (EUC)): 1) In-ED brief session, discussing home safety \& nutrition 2) Eight-week longitudinal home safety \& nutrition text-message program
|
|---|---|---|
|
Change in Peer Violence Involvement
CTS Score: Baseline
|
3.0 units on a scale
Interval 0.0 to 36.0
|
2.0 units on a scale
Interval 0.0 to 9.0
|
|
Change in Peer Violence Involvement
CTS Score: 16 week
|
2.0 units on a scale
Interval 0.0 to 29.0
|
1.0 units on a scale
Interval 0.0 to 32.0
|
|
Change in Peer Violence Involvement
CTS Score where baseline >=4: Baseline
|
8.0 units on a scale
Interval 0.0 to 32.0
|
6.5 units on a scale
Interval 0.0 to 15.0
|
|
Change in Peer Violence Involvement
CTS Score where baseline >=4: 8 week
|
4.0 units on a scale
Interval 0.0 to 27.0
|
4.0 units on a scale
Interval 0.0 to 14.0
|
|
Change in Peer Violence Involvement
CTS Score where baseline >=4: 16 week
|
2.0 units on a scale
Interval 0.0 to 29.0
|
5.0 units on a scale
Interval 0.0 to 32.0
|
|
Change in Peer Violence Involvement
CTS Score: 8 week
|
2.5 units on a scale
Interval 0.0 to 29.0
|
3.0 units on a scale
Interval 0.0 to 15.0
|
SECONDARY outcome
Timeframe: 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment (8 wks after close of intervention)Retention Rate: % of consented participants who completed follow up
Outcome measures
| Measure |
iDOVE Intervention (ED+Text)
n=58 Participants
1. In-ED brief session, introducing basic principles of cognitive behavioral theory (CBT) and the structure of the text-message portion of the intervention
2. Eight-week longitudinal tailored CBT-based text-message program
iDOVE Intervention (ED+text): 1) In-ED brief session, introducing basic principles of cognitive behavioral theory (CBT) and the structure of the text-message portion of the intervention 2) Eight-week longitudinal tailored text-message program
|
Control (EUC)
n=58 Participants
1. In-ED brief session, discussing home safety \& nutrition
2. Eight-week longitudinal home safety \& nutrition text-message program
Control (Enhanced Usual Care (EUC)): 1) In-ED brief session, discussing home safety \& nutrition 2) Eight-week longitudinal home safety \& nutrition text-message program
|
|---|---|---|
|
Acceptability/Feasibility: Follow Up Rate
8 week follow up
|
55 Participants
|
55 Participants
|
|
Acceptability/Feasibility: Follow Up Rate
16 week follow up
|
54 Participants
|
52 Participants
|
SECONDARY outcome
Timeframe: Enrollment to 16 weeks post-enrollmentAmong the intervention group, how many participants responded to at least one of the daily text message queries, and how many requested on-demand support text-messages.
Outcome measures
| Measure |
iDOVE Intervention (ED+Text)
n=58 Participants
1. In-ED brief session, introducing basic principles of cognitive behavioral theory (CBT) and the structure of the text-message portion of the intervention
2. Eight-week longitudinal tailored CBT-based text-message program
iDOVE Intervention (ED+text): 1) In-ED brief session, introducing basic principles of cognitive behavioral theory (CBT) and the structure of the text-message portion of the intervention 2) Eight-week longitudinal tailored text-message program
|
Control (EUC)
1. In-ED brief session, discussing home safety \& nutrition
2. Eight-week longitudinal home safety \& nutrition text-message program
Control (Enhanced Usual Care (EUC)): 1) In-ED brief session, discussing home safety \& nutrition 2) Eight-week longitudinal home safety \& nutrition text-message program
|
|---|---|---|
|
Acceptability/Feasibility: Engagement of Intervention Group
Responded to >=1 of the daily mood queries
|
56 Participants
|
—
|
|
Acceptability/Feasibility: Engagement of Intervention Group
Requested on-demand support text-messages
|
22 Participants
|
—
|
SECONDARY outcome
Timeframe: 8 weeks post-enrollment (close of intervention)The Customer Satisfaction Questionnaire (CSQ-8) developed by Larsen et al. (1979) is an 8-item survey where each item is scored 1 (poor) to 4 (excellent). It is scored by summing the individual item scores to produce a range of 8 to 32, with high scores indicating greater satisfaction.
Outcome measures
| Measure |
iDOVE Intervention (ED+Text)
n=58 Participants
1. In-ED brief session, introducing basic principles of cognitive behavioral theory (CBT) and the structure of the text-message portion of the intervention
2. Eight-week longitudinal tailored CBT-based text-message program
iDOVE Intervention (ED+text): 1) In-ED brief session, introducing basic principles of cognitive behavioral theory (CBT) and the structure of the text-message portion of the intervention 2) Eight-week longitudinal tailored text-message program
|
Control (EUC)
n=58 Participants
1. In-ED brief session, discussing home safety \& nutrition
2. Eight-week longitudinal home safety \& nutrition text-message program
Control (Enhanced Usual Care (EUC)): 1) In-ED brief session, discussing home safety \& nutrition 2) Eight-week longitudinal home safety \& nutrition text-message program
|
|---|---|---|
|
Acceptability/Feasibility: Participant Satisfaction
|
32.3 units on a scale
Standard Deviation 5.7
|
31.2 units on a scale
Standard Deviation 5.5
|
Adverse Events
iDOVE Intervention (ED+Text)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control (EUC)
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
Megan L. Ranney, MD, MPH, FACEP
Department of Emergency Medicine, Alpert Medical School, Brown University
Phone: 401-444-2557
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place