Trial Outcomes & Findings for Evaluation of a Therapeutic Mobile App for Depression (NCT NCT05601362)
NCT ID: NCT05601362
Last Updated: 2026-07-06
Results Overview
8-item self-report measure of depression symptom severity (Range: 0-24, higher scores indicate greater depression severity)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
110 participants
Primary outcome timeframe
End of treatment (4 week treatment phase)
Results posted on
2026-07-06
Participant Flow
Participant milestones
| Measure |
Active Training
In this group, participants were trained to look at happy faces over sad faces 80% of the time.
|
Control Training
In this condition, participants were trained to look at happy faces only 50% of the time.
|
|---|---|---|
|
Overall Study
STARTED
|
55
|
55
|
|
Overall Study
COMPLETED
|
50
|
47
|
|
Overall Study
NOT COMPLETED
|
5
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Some participants may have identified with more than one race.
Baseline characteristics by cohort
| Measure |
Gamified Attention Bias Modification
n=50 Participants
Digital therapeutic intervention based on Attention Bias Modification Training (ABMT) designed to decrease negative attention bias.
Gamified Attention Bias Modification: Gamified computerized behavioral therapy with therapeutic intervention based on Attention Bias Modification Training (ABMT).
|
Gamified Placebo Training
n=47 Participants
Identical version of the gamified behavioral intervention without manipulation designed to decrease negative attention bias
Gamified Placebo Training: Placebo version of Gamified Attention Bias Modification. (Identical version of the gamified behavioral intervention without manipulation designed to decrease negative attention bias).
|
Total
n=97 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
50 Participants
n=9 Participants
|
47 Participants
n=27 Participants
|
97 Participants
n=267 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Age, Continuous
|
30.88 Years
STANDARD_DEVIATION 6.68 • n=9 Participants
|
29.57 Years
STANDARD_DEVIATION 7.25 • n=27 Participants
|
30.25 Years
STANDARD_DEVIATION 6.96 • n=267 Participants
|
|
Sex/Gender, Customized
Sex · Male
|
4 Participants
n=9 Participants
|
7 Participants
n=27 Participants
|
11 Participants
n=267 Participants
|
|
Sex/Gender, Customized
Sex · Female
|
36 Participants
n=9 Participants
|
38 Participants
n=27 Participants
|
74 Participants
n=267 Participants
|
|
Sex/Gender, Customized
Sex · Other
|
10 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
12 Participants
n=267 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
2 Participants
n=9 Participants • Some participants may have identified with more than one race.
|
1 Participants
n=27 Participants • Some participants may have identified with more than one race.
|
3 Participants
n=267 Participants • Some participants may have identified with more than one race.
|
|
Race/Ethnicity, Customized
Race · Asian
|
5 Participants
n=9 Participants • Some participants may have identified with more than one race.
|
5 Participants
n=27 Participants • Some participants may have identified with more than one race.
|
10 Participants
n=267 Participants • Some participants may have identified with more than one race.
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
2 Participants
n=9 Participants • Some participants may have identified with more than one race.
|
2 Participants
n=27 Participants • Some participants may have identified with more than one race.
|
4 Participants
n=267 Participants • Some participants may have identified with more than one race.
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants • Some participants may have identified with more than one race.
|
0 Participants
n=27 Participants • Some participants may have identified with more than one race.
|
0 Participants
n=267 Participants • Some participants may have identified with more than one race.
|
|
Race/Ethnicity, Customized
Race · White
|
41 Participants
n=9 Participants • Some participants may have identified with more than one race.
|
38 Participants
n=27 Participants • Some participants may have identified with more than one race.
|
79 Participants
n=267 Participants • Some participants may have identified with more than one race.
|
|
Race/Ethnicity, Customized
Race · Other
|
0 Participants
n=9 Participants • Some participants may have identified with more than one race.
|
1 Participants
n=27 Participants • Some participants may have identified with more than one race.
|
1 Participants
n=267 Participants • Some participants may have identified with more than one race.
|
|
Race/Ethnicity, Customized
Race · Declined to answer
|
0 Participants
n=9 Participants • Some participants may have identified with more than one race.
|
0 Participants
n=27 Participants • Some participants may have identified with more than one race.
|
0 Participants
n=267 Participants • Some participants may have identified with more than one race.
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic/Latino
|
4 Participants
n=9 Participants
|
6 Participants
n=27 Participants
|
10 Participants
n=267 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Non-Hispanic
|
46 Participants
n=9 Participants
|
41 Participants
n=27 Participants
|
87 Participants
n=267 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=9 Participants
|
47 participants
n=27 Participants
|
97 participants
n=267 Participants
|
PRIMARY outcome
Timeframe: End of treatment (4 week treatment phase)8-item self-report measure of depression symptom severity (Range: 0-24, higher scores indicate greater depression severity)
Outcome measures
| Measure |
Active Training
n=50 Participants
In this group, participants were trained to look at happy faces over sad faces 80% of the time.
|
Control Training
n=47 Participants
In this condition, participants were trained to look at happy faces only 50% of the time.
|
|---|---|---|
|
Patient Health Questionnaire - 8 (PHQ-8)
|
11.4 points
Standard Error 0.566
|
11.9 points
Standard Error 0.591
|
SECONDARY outcome
Timeframe: End of treatment (4 week treatment phase)5-item self-report measure of rumination frequency (Range: 1-20, higher scores indicate more rumination)
Outcome measures
| Measure |
Active Training
n=50 Participants
In this group, participants were trained to look at happy faces over sad faces 80% of the time.
|
Control Training
n=47 Participants
In this condition, participants were trained to look at happy faces only 50% of the time.
|
|---|---|---|
|
Ruminative Response Scale - Brooding Subscale (RRS-B)
|
12.3 points
Standard Error 0.378
|
11.8 points
Standard Error 0.398
|
SECONDARY outcome
Timeframe: End of treatment (4 week treatment phase)3-item self-report measure of rumination frequency (Range: 0-12, higher scores indicate more rumination)
Outcome measures
| Measure |
Active Training
n=50 Participants
In this group, participants were trained to look at happy faces over sad faces 80% of the time.
|
Control Training
n=47 Participants
In this condition, participants were trained to look at happy faces only 50% of the time.
|
|---|---|---|
|
Perseverative Thinking Questionnaire (PTQ) -"Difficult to Disengage From" Subscale
|
6.26 points
Standard Error 0.355
|
6.49 points
Standard Error 0.371
|
SECONDARY outcome
Timeframe: End of treatment (4 week treatment phase)10-item measure of dysphoria and depression symptoms (Range: 10-50, higher scores indicate greater dysphoria)
Outcome measures
| Measure |
Active Training
n=50 Participants
In this group, participants were trained to look at happy faces over sad faces 80% of the time.
|
Control Training
n=47 Participants
In this condition, participants were trained to look at happy faces only 50% of the time.
|
|---|---|---|
|
Inventory of Depression and Anxiety Symptoms (IDAS) Dysphoria Subscale
|
28.3 points
Standard Error 0.914
|
29.4 points
Standard Error 0.955
|
OTHER_PRE_SPECIFIED outcome
Timeframe: End of treatment (4 week treatment phase)Mean scan time for viewing sad stimuli assessed via mousetracking, controlling for baseline score
Outcome measures
| Measure |
Active Training
n=50 Participants
In this group, participants were trained to look at happy faces over sad faces 80% of the time.
|
Control Training
n=47 Participants
In this condition, participants were trained to look at happy faces only 50% of the time.
|
|---|---|---|
|
Attention Bias (Mousetracking)
|
6572 milliseconds
Standard Error 253
|
6654 milliseconds
Standard Error 265
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed daily over 4 weeks, end of treatment at week 4 reportedRumination assessed via smartphone-delivered ecological momentary assessment items used in prior EMA research (Smith et al., 2021)). (Range: 4-20, higher scores indicate more rumination); tested time by condition interaction
Outcome measures
| Measure |
Active Training
n=50 Participants
In this group, participants were trained to look at happy faces over sad faces 80% of the time.
|
Control Training
n=47 Participants
In this condition, participants were trained to look at happy faces only 50% of the time.
|
|---|---|---|
|
General Rumination
|
10.4 points
Standard Error 0.522
|
10.5 points
Standard Error 0.535
|
Adverse Events
Active Training
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Training
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