Trial Outcomes & Findings for Self-guided Treatment for Adolescents Navigating Depression (NCT NCT05462652)
NCT ID: NCT05462652
Last Updated: 2024-06-12
Results Overview
Measured by the Patient Health Questionnaire (PHQ-8), an 8-item participant-report measure for screening for depression and for establishing depression severity. The total score ranges from 0-24, with a higher score indicating greater depression symptom severity.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
223 participants
Primary outcome timeframe
Post-intervention (5 week timepoint)
Results posted on
2024-06-12
Participant Flow
Participant milestones
| Measure |
Active Intervention
The active intervention is a 5-week program divided into 5 levels intended to be completed weekly. Each level is expected to take about 60 minutes to complete. Activities in each level may include reading text on the screen, answering multiple choice style questions, swiping or clicking a button to move through screens, dragging and dropping elements on screen, and completing tasks outside of the app. Certain on-demand resources can be accessed in the apps at any time, including crisis resources. Where appropriate, text entries in the app that match a database of concerning words/phrases will trigger an automated pop-up suggesting participants visit the in-app crisis resources if they need additional support. Text entries will also be monitored by study staff for safety, though not in real-time. Participants will be instructed to complete a weekly PHQ-8 assessment in the mobile app.
|
Usual Care
UC is based on a stepped care model for treatment for symptoms of depression. It can include any of the following: active monitoring of depressive symptoms and suicidality, supportive counseling by a healthcare provider, psychosocial support interventions, collaborative care (e.g. facilitation of parental and patient self-management, referral for peer support or other community or school-based behavioral health programs), psychoeducation, complementary and alternative medicine approaches, psychotherapy (e.g. behavioral treatment, interpersonal therapy, cognitive behavioral therapy), pharmacotherapy for mood problems, visit to a primary care provider, behavioral or mental health specialist or therapist, counselor or coach for mood disorder. For purposes of this study, UC will be enhanced by prompting participants to complete a weekly PHQ-8 assessment in a mobile app.
|
|---|---|---|
|
Overall Study
STARTED
|
111
|
112
|
|
Overall Study
COMPLETED
|
96
|
98
|
|
Overall Study
NOT COMPLETED
|
15
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
One participant from each group indicated that their sex at birth was "Unknown". Due to system constraints, it is not possible to enter anything other than Female or Male on this form.
Baseline characteristics by cohort
| Measure |
Active Intervention
n=111 Participants
The active intervention is a 5-week program divided into 5 levels intended to be completed weekly. Each level is expected to take about 60 minutes to complete. Activities in each level may include reading text on the screen, answering multiple choice style questions, swiping or clicking a button to move through screens, dragging and dropping elements on screen, and completing tasks outside of the app. Certain on-demand resources can be accessed in the apps at any time, including crisis resources. Where appropriate, text entries in the app that match a database of concerning words/phrases will trigger an automated pop-up suggesting participants visit the in-app crisis resources if they need additional support. Text entries will also be monitored by study staff for safety, though not in real-time. Participants will be instructed to complete a weekly PHQ-8 assessment in the mobile app.
|
Usual Care
n=112 Participants
UC is based on a stepped care model for treatment for symptoms of depression. It can include any of the following: active monitoring of depressive symptoms and suicidality, supportive counseling by a healthcare provider, psychosocial support interventions, collaborative care (e.g. facilitation of parental and patient self-management, referral for peer support or other community or school-based behavioral health programs), psychoeducation, complementary and alternative medicine approaches, psychotherapy (e.g. behavioral treatment, interpersonal therapy, cognitive behavioral therapy), pharmacotherapy for mood problems, visit to a primary care provider, behavioral or mental health specialist or therapist, counselor or coach for mood disorder. For purposes of this study, UC will be enhanced by prompting participants to complete a weekly PHQ-8 assessment in a mobile app.
|
Total
n=223 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
54 Participants
n=111 Participants
|
56 Participants
n=112 Participants
|
110 Participants
n=223 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
57 Participants
n=111 Participants
|
56 Participants
n=112 Participants
|
113 Participants
n=223 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=111 Participants
|
0 Participants
n=112 Participants
|
0 Participants
n=223 Participants
|
|
Age, Continuous
|
17.3 years
STANDARD_DEVIATION 2.6 • n=111 Participants
|
17.2 years
STANDARD_DEVIATION 2.7 • n=112 Participants
|
17.3 years
STANDARD_DEVIATION 2.6 • n=223 Participants
|
|
Sex/Gender, Customized
Gender Identity : Girl/Woman
|
61 participants
n=111 Participants
|
65 participants
n=112 Participants
|
126 participants
n=223 Participants
|
|
Sex/Gender, Customized
Gender Identity : Boy/Man
|
35 participants
n=111 Participants
|
33 participants
n=112 Participants
|
68 participants
n=223 Participants
|
|
Sex/Gender, Customized
Gender Identity : Non-binary
|
13 participants
n=111 Participants
|
16 participants
n=112 Participants
|
29 participants
n=223 Participants
|
|
Sex/Gender, Customized
Gender Identity : Transgender
|
13 participants
n=111 Participants
|
10 participants
n=112 Participants
|
23 participants
n=223 Participants
|
|
Sex/Gender, Customized
Gender Identity : Intersex
|
1 participants
n=111 Participants
|
0 participants
n=112 Participants
|
1 participants
n=223 Participants
|
|
Sex/Gender, Customized
Gender Identity : Other
|
8 participants
n=111 Participants
|
4 participants
n=112 Participants
|
12 participants
n=223 Participants
|
|
Sex/Gender, Customized
Gender Identity : I prefer not to say
|
2 participants
n=111 Participants
|
3 participants
n=112 Participants
|
5 participants
n=223 Participants
|
|
Sex: Female, Male
Female
|
82 Participants
n=110 Participants • One participant from each group indicated that their sex at birth was "Unknown". Due to system constraints, it is not possible to enter anything other than Female or Male on this form.
|
81 Participants
n=111 Participants • One participant from each group indicated that their sex at birth was "Unknown". Due to system constraints, it is not possible to enter anything other than Female or Male on this form.
|
163 Participants
n=221 Participants • One participant from each group indicated that their sex at birth was "Unknown". Due to system constraints, it is not possible to enter anything other than Female or Male on this form.
|
|
Sex: Female, Male
Male
|
28 Participants
n=110 Participants • One participant from each group indicated that their sex at birth was "Unknown". Due to system constraints, it is not possible to enter anything other than Female or Male on this form.
|
30 Participants
n=111 Participants • One participant from each group indicated that their sex at birth was "Unknown". Due to system constraints, it is not possible to enter anything other than Female or Male on this form.
|
58 Participants
n=221 Participants • One participant from each group indicated that their sex at birth was "Unknown". Due to system constraints, it is not possible to enter anything other than Female or Male on this form.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=111 Participants
|
15 Participants
n=112 Participants
|
30 Participants
n=223 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
87 Participants
n=111 Participants
|
89 Participants
n=112 Participants
|
176 Participants
n=223 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=111 Participants
|
8 Participants
n=112 Participants
|
17 Participants
n=223 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=111 Participants
|
1 Participants
n=112 Participants
|
3 Participants
n=223 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=111 Participants
|
4 Participants
n=112 Participants
|
11 Participants
n=223 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=111 Participants
|
0 Participants
n=112 Participants
|
0 Participants
n=223 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=111 Participants
|
8 Participants
n=112 Participants
|
19 Participants
n=223 Participants
|
|
Race (NIH/OMB)
White
|
77 Participants
n=111 Participants
|
86 Participants
n=112 Participants
|
163 Participants
n=223 Participants
|
|
Race (NIH/OMB)
More than one race
|
11 Participants
n=111 Participants
|
11 Participants
n=112 Participants
|
22 Participants
n=223 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=111 Participants
|
2 Participants
n=112 Participants
|
5 Participants
n=223 Participants
|
|
Patient Health Questionnaire-8 (PHQ-8)
|
12.14 units on a scale
STANDARD_DEVIATION 4.28 • n=111 Participants
|
12.59 units on a scale
STANDARD_DEVIATION 4.24 • n=112 Participants
|
12.37 units on a scale
STANDARD_DEVIATION 4.26 • n=223 Participants
|
PRIMARY outcome
Timeframe: Post-intervention (5 week timepoint)Population: Intention to Treat
Measured by the Patient Health Questionnaire (PHQ-8), an 8-item participant-report measure for screening for depression and for establishing depression severity. The total score ranges from 0-24, with a higher score indicating greater depression symptom severity.
Outcome measures
| Measure |
Active Intervention
n=111 Participants
The active intervention is a 5-week program divided into 5 levels intended to be completed weekly. Each level is expected to take about 60 minutes to complete. Activities in each level may include reading text on the screen, answering multiple choice style questions, swiping or clicking a button to move through screens, dragging and dropping elements on screen, and completing tasks outside of the app. Certain on-demand resources can be accessed in the apps at any time, including crisis resources. Where appropriate, text entries in the app that match a database of concerning words/phrases will trigger an automated pop-up suggesting participants visit the in-app crisis resources if they need additional support. Text entries will also be monitored by study staff for safety, though not in real-time. Participants will be instructed to complete a weekly PHQ-8 assessment in the mobile app.
|
Usual Care
n=112 Participants
UC is based on a stepped care model for treatment for symptoms of depression. It can include any of the following: active monitoring of depressive symptoms and suicidality, supportive counseling by a healthcare provider, psychosocial support interventions, collaborative care (e.g. facilitation of parental and patient self-management, referral for peer support or other community or school-based behavioral health programs), psychoeducation, complementary and alternative medicine approaches, psychotherapy (e.g. behavioral treatment, interpersonal therapy, cognitive behavioral therapy), pharmacotherapy for mood problems, visit to a primary care provider, behavioral or mental health specialist or therapist, counselor or coach for mood disorder. For purposes of this study, UC will be enhanced by prompting participants to complete a weekly PHQ-8 assessment in a mobile app.
|
|---|---|---|
|
Depressive Symptom Severity at Post-intervention
|
8.39 units on a scale
Standard Error 0.38
|
11.03 units on a scale
Standard Error 0.37
|
SECONDARY outcome
Timeframe: Change from baseline to post-intervention (5 weeks)Population: Missing values imputed with multiple imputation.
Measured by the Patient Health Questionnaire (PHQ-8) an 8-item participant-report measure for screening for depression and for establishing depression severity. The total score ranges from 0-24, with a higher score indicating greater depression symptom severity. Intervention response is defined as a 50% reduction in PHQ-8 score from baseline.
Outcome measures
| Measure |
Active Intervention
n=111 Participants
The active intervention is a 5-week program divided into 5 levels intended to be completed weekly. Each level is expected to take about 60 minutes to complete. Activities in each level may include reading text on the screen, answering multiple choice style questions, swiping or clicking a button to move through screens, dragging and dropping elements on screen, and completing tasks outside of the app. Certain on-demand resources can be accessed in the apps at any time, including crisis resources. Where appropriate, text entries in the app that match a database of concerning words/phrases will trigger an automated pop-up suggesting participants visit the in-app crisis resources if they need additional support. Text entries will also be monitored by study staff for safety, though not in real-time. Participants will be instructed to complete a weekly PHQ-8 assessment in the mobile app.
|
Usual Care
n=112 Participants
UC is based on a stepped care model for treatment for symptoms of depression. It can include any of the following: active monitoring of depressive symptoms and suicidality, supportive counseling by a healthcare provider, psychosocial support interventions, collaborative care (e.g. facilitation of parental and patient self-management, referral for peer support or other community or school-based behavioral health programs), psychoeducation, complementary and alternative medicine approaches, psychotherapy (e.g. behavioral treatment, interpersonal therapy, cognitive behavioral therapy), pharmacotherapy for mood problems, visit to a primary care provider, behavioral or mental health specialist or therapist, counselor or coach for mood disorder. For purposes of this study, UC will be enhanced by prompting participants to complete a weekly PHQ-8 assessment in a mobile app.
|
|---|---|---|
|
Intervention Response at Post-intervention
Intervention Response (Yes)
|
31.7 percentage of participants
Interval 22.5 to 40.8
|
11.6 percentage of participants
Interval 5.2 to 18.0
|
|
Intervention Response at Post-intervention
Intervention Response (No)
|
68.3 percentage of participants
Interval 59.2 to 77.5
|
88.4 percentage of participants
Interval 82.0 to 94.8
|
SECONDARY outcome
Timeframe: Post-intervention (5 week timepoint)Population: Missing values imputed with multiple imputation.
Measured by the Patient Health Questionnaire (PHQ-8) an 8-item participant-report measure for screening for depression and for establishing depression severity. The total score ranges from 0-24, with a higher score indicating greater depression symptom severity. Remission is defined as a PHQ-8 score less than 5 at post-intervention.
Outcome measures
| Measure |
Active Intervention
n=111 Participants
The active intervention is a 5-week program divided into 5 levels intended to be completed weekly. Each level is expected to take about 60 minutes to complete. Activities in each level may include reading text on the screen, answering multiple choice style questions, swiping or clicking a button to move through screens, dragging and dropping elements on screen, and completing tasks outside of the app. Certain on-demand resources can be accessed in the apps at any time, including crisis resources. Where appropriate, text entries in the app that match a database of concerning words/phrases will trigger an automated pop-up suggesting participants visit the in-app crisis resources if they need additional support. Text entries will also be monitored by study staff for safety, though not in real-time. Participants will be instructed to complete a weekly PHQ-8 assessment in the mobile app.
|
Usual Care
n=112 Participants
UC is based on a stepped care model for treatment for symptoms of depression. It can include any of the following: active monitoring of depressive symptoms and suicidality, supportive counseling by a healthcare provider, psychosocial support interventions, collaborative care (e.g. facilitation of parental and patient self-management, referral for peer support or other community or school-based behavioral health programs), psychoeducation, complementary and alternative medicine approaches, psychotherapy (e.g. behavioral treatment, interpersonal therapy, cognitive behavioral therapy), pharmacotherapy for mood problems, visit to a primary care provider, behavioral or mental health specialist or therapist, counselor or coach for mood disorder. For purposes of this study, UC will be enhanced by prompting participants to complete a weekly PHQ-8 assessment in a mobile app.
|
|---|---|---|
|
Remission at Post-intervention
|
24.9 percentage of participants
Interval 16.4 to 33.4
|
9.4 percentage of participants
Interval 3.9 to 15.0
|
SECONDARY outcome
Timeframe: Change from baseline to post-intervention (5 weeks)Population: Intention to treat. Missing values are imputed with multiple imputation.
Measured by the Patient Health Questionnaire (PHQ-8) an 8-item participant-report measure for screening for depression and for establishing depression severity. The total score ranges from 0-24, with a higher score indicating greater depression symptom severity. Clinically-meaningful reduction is defined as a ≥5 point reduction in PHQ-8 score from baseline.
Outcome measures
| Measure |
Active Intervention
n=111 Participants
The active intervention is a 5-week program divided into 5 levels intended to be completed weekly. Each level is expected to take about 60 minutes to complete. Activities in each level may include reading text on the screen, answering multiple choice style questions, swiping or clicking a button to move through screens, dragging and dropping elements on screen, and completing tasks outside of the app. Certain on-demand resources can be accessed in the apps at any time, including crisis resources. Where appropriate, text entries in the app that match a database of concerning words/phrases will trigger an automated pop-up suggesting participants visit the in-app crisis resources if they need additional support. Text entries will also be monitored by study staff for safety, though not in real-time. Participants will be instructed to complete a weekly PHQ-8 assessment in the mobile app.
|
Usual Care
n=112 Participants
UC is based on a stepped care model for treatment for symptoms of depression. It can include any of the following: active monitoring of depressive symptoms and suicidality, supportive counseling by a healthcare provider, psychosocial support interventions, collaborative care (e.g. facilitation of parental and patient self-management, referral for peer support or other community or school-based behavioral health programs), psychoeducation, complementary and alternative medicine approaches, psychotherapy (e.g. behavioral treatment, interpersonal therapy, cognitive behavioral therapy), pharmacotherapy for mood problems, visit to a primary care provider, behavioral or mental health specialist or therapist, counselor or coach for mood disorder. For purposes of this study, UC will be enhanced by prompting participants to complete a weekly PHQ-8 assessment in a mobile app.
|
|---|---|---|
|
Clinically-meaningful Reduction in Severity at Post-intervention
|
40.5 percentage of participants
Interval 30.9 to 50.1
|
15.8 percentage of participants
Interval 8.9 to 22.7
|
Adverse Events
Active Intervention
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Active Intervention
n=111 participants at risk
The active intervention is a 5-week program divided into 5 levels intended to be completed weekly. Each level is expected to take about 60 minutes to complete. Activities in each level may include reading text on the screen, answering multiple choice style questions, swiping or clicking a button to move through screens, dragging and dropping elements on screen, and completing tasks outside of the app. Certain on-demand resources can be accessed in the apps at any time, including crisis resources. Where appropriate, text entries in the app that match a database of concerning words/phrases will trigger an automated pop-up suggesting participants visit the in-app crisis resources if they need additional support. Text entries will also be monitored by study staff for safety, though not in real-time. Participants will be instructed to complete a weekly PHQ-8 assessment in the mobile app.
|
Usual Care
n=112 participants at risk
UC is based on a stepped care model for treatment for symptoms of depression. It can include any of the following: active monitoring of depressive symptoms and suicidality, supportive counseling by a healthcare provider, psychosocial support interventions, collaborative care (e.g. facilitation of parental and patient self-management, referral for peer support or other community or school-based behavioral health programs), psychoeducation, complementary and alternative medicine approaches, psychotherapy (e.g. behavioral treatment, interpersonal therapy, cognitive behavioral therapy), pharmacotherapy for mood problems, visit to a primary care provider, behavioral or mental health specialist or therapist, counselor or coach for mood disorder. For purposes of this study, UC will be enhanced by prompting participants to complete a weekly PHQ-8 assessment in a mobile app.
|
|---|---|---|
|
Psychiatric disorders
Hospitalization
|
1.8%
2/111 • Through study completion, up to 11 weeks after randomization
|
0.00%
0/112 • Through study completion, up to 11 weeks after randomization
|
|
Social circumstances
Victim of violence
|
0.00%
0/111 • Through study completion, up to 11 weeks after randomization
|
0.89%
1/112 • Through study completion, up to 11 weeks after randomization
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place