Trial Outcomes & Findings for Digital Intervention to Treat Anxiety and Depression Among Persons Receiving Treatment for Opioid Use Disorder (NCT NCT05047627)
NCT ID: NCT05047627
Last Updated: 2025-11-05
Results Overview
Assesses anxiety symptoms. Possible GAD-Q-IV scores range from 0 to 12, with higher scores representing greater GAD symptom severity
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
63 participants
Primary outcome timeframe
From Baseline to 4 weeks (post-intervention) and from Baseline to 8 weeks (follow-up).
Results posted on
2025-11-05
Participant Flow
Participant milestones
| Measure |
Smartphone Digital Intervention Group
Participants in the smartphone digital intervention group downloaded the "Mood Triggers" application and were asked to engage with the intervention four to six times per week for four weeks, completing 20 brief (\~2 minute) CBT-based video sessions. The app passively collected data on ambient light, GPS location, call/text logs, and screen time. Each video guided participants through exercises designed to manage anxiety and depression symptoms, such as progressive muscle relaxation and problem-solving strategies. The videos were categorized into modules including Actions, Mental Hygiene, Exposure, Acceptance, Cognitions, Regulation and Positive Feelings, and Preparation. The app also included optional daily prompts on mood and anxiety, adapted from the PANAS-X, to encourage self-monitoring.
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Wait List Control Condition
The waitlist control group did not receive the digital intervention treatment during the eight-week study. Participants in this group were offered access to the intervention after completing the study. A phone onboarding session was available but not mandatory for the control group, unlike the intervention group.
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|---|---|---|
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Overall Study
STARTED
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32
|
31
|
|
Overall Study
COMPLETED
|
27
|
29
|
|
Overall Study
NOT COMPLETED
|
5
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2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Digital Intervention to Treat Anxiety and Depression Among Persons Receiving Treatment for Opioid Use Disorder
Baseline characteristics by cohort
| Measure |
Smartphone Digital Intervention Group
n=32 Participants
The Smartphone Digital Intervention Group was the experimental group. Participants randomized to this group downloaded the "Mood Triggers" smartphone application and were asked to use it 4-6 times per week for four weeks, completing 20 digital video sessions. The app passively and continuously collected data on ambient light, GPS location, call and text logs, and screen time. The intervention, based on cognitive-behavioral therapy (CBT) principles, delivered brief informational videos (averaging \~2 minutes) that guided participants through exercises to manage symptoms of anxiety and depression. Examples of these exercises included progressive muscle relaxation, problem-solving strategies, and relapse prevention. The app also featured optional daily prompts, adapted from the PANAS-X, to encourage self-monitoring of mood and anxiety. The videos were organized into modules addressing actions, mental hygiene, exposure, acceptance, cognitions, regulation and positive feelings, and preparation.
|
Wait List Control Condition
n=31 Participants
The waitlist control group did not receive the digital intervention treatment during the eight-week study. They provided urine samples bi-weekly and were offered access to the digital intervention after completing their study participation.
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Total
n=63 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
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38.74 years
STANDARD_DEVIATION 9.20 • n=15 Participants
|
35.47 years
STANDARD_DEVIATION 9.89 • n=161 Participants
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37.08 years
STANDARD_DEVIATION 9.62 • n=100 Participants
|
|
Sex/Gender, Customized
Gender · Man
|
18 Participants
n=15 Participants
|
14 Participants
n=161 Participants
|
32 Participants
n=100 Participants
|
|
Sex/Gender, Customized
Gender · Woman
|
13 Participants
n=15 Participants
|
16 Participants
n=161 Participants
|
29 Participants
n=100 Participants
|
|
Sex/Gender, Customized
Gender · Prefer not to disclose
|
1 Participants
n=15 Participants
|
1 Participants
n=161 Participants
|
2 Participants
n=100 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
27 Participants
n=15 Participants
|
17 Participants
n=161 Participants
|
44 Participants
n=100 Participants
|
|
Race/Ethnicity, Customized
Race · Other/multiracial
|
4 Participants
n=15 Participants
|
12 Participants
n=161 Participants
|
16 Participants
n=100 Participants
|
|
Race/Ethnicity, Customized
Race · Prefer not to disclose
|
1 Participants
n=15 Participants
|
2 Participants
n=161 Participants
|
3 Participants
n=100 Participants
|
|
Depression Severity as Measured by the Patient Health Questionnaire-9 (PHQ-9)
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16.05 units on a scale
STANDARD_DEVIATION 6.37 • n=15 Participants
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16.41 units on a scale
STANDARD_DEVIATION 6.04 • n=161 Participants
|
16.23 units on a scale
STANDARD_DEVIATION 6.16 • n=100 Participants
|
|
Anxiety Severity as Measured by the Generalized Anxiety Disorder Questionnaire-IV (GAD-Q-IV)
|
10.13 units on a scale
STANDARD_DEVIATION 2.17 • n=15 Participants
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10.18 units on a scale
STANDARD_DEVIATION 2.2 • n=161 Participants
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10.15 units on a scale
STANDARD_DEVIATION 2.17 • n=100 Participants
|
|
Opioid Use Disorder Severity as Measured by the Rapid Opioid Dependence Screen (RODS)
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8.79 units on a scale
STANDARD_DEVIATION 0.75 • n=15 Participants
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8.82 units on a scale
STANDARD_DEVIATION 0.62 • n=161 Participants
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8.80 units on a scale
STANDARD_DEVIATION 0.68 • n=100 Participants
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Opioid Craving Severity as Measured by the Opioid Craving Scale (OCS)
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6.54 units on a scale
STANDARD_DEVIATION 3.91 • n=15 Participants
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6.35 units on a scale
STANDARD_DEVIATION 3.21 • n=161 Participants
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6.45 units on a scale
STANDARD_DEVIATION 3.56 • n=100 Participants
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PRIMARY outcome
Timeframe: From Baseline to 4 weeks (post-intervention) and from Baseline to 8 weeks (follow-up).Assesses anxiety symptoms. Possible GAD-Q-IV scores range from 0 to 12, with higher scores representing greater GAD symptom severity
Outcome measures
| Measure |
Smartphone Digital Intervention Group (Experimental Group)
n=32 Participants
Participants in the smartphone digital intervention group downloaded the "Mood Triggers" application and were asked to engage with the intervention four to six times per week for four weeks, completing 20 brief (\~2 minute) CBT-based video sessions. The app passively collected data on ambient light, GPS location, call/text logs, and screen time. Each video guided participants through exercises designed to manage anxiety and depression symptoms, such as progressive muscle relaxation and problem-solving strategies. The videos were categorized into modules including Actions, Mental Hygiene, Exposure, Acceptance, Cognitions, Regulation and Positive Feelings, and Preparation. The app also included optional daily prompts on mood and anxiety, adapted from the PANAS-X, to encourage self-monitoring.
|
Wait List Control Condition
n=31 Participants
The wait list control condition will not receive the digital intervention treatment for the duration of the study. They will still provide urine samples during the study. Participants assigned to this condition will be able to access the digital intervention after their participation in the study.
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|---|---|---|
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Change in Anxiety Symptoms as Assessed by Generalized Anxiety Disorder- Q-IV Scale
Pre-Post
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-1.8 units on a scale
Interval -4.36 to 0.76
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-1.04 units on a scale
Interval -5.37 to 3.28
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Change in Anxiety Symptoms as Assessed by Generalized Anxiety Disorder- Q-IV Scale
Pre-Followup
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-2.47 units on a scale
Interval -5.72 to 0.78
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-1.53 units on a scale
Interval -4.64 to 1.59
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PRIMARY outcome
Timeframe: From Baseline to 4 weeks (post-intervention) and from Baseline to 8 weeks (follow-up).Assesses depressive symptoms, the PHQ-9 score can range from 0 to 27, since each of the 9 items can be scored from 0 (not at all) to 3 (nearly every day)
Outcome measures
| Measure |
Smartphone Digital Intervention Group (Experimental Group)
n=32 Participants
Participants in the smartphone digital intervention group downloaded the "Mood Triggers" application and were asked to engage with the intervention four to six times per week for four weeks, completing 20 brief (\~2 minute) CBT-based video sessions. The app passively collected data on ambient light, GPS location, call/text logs, and screen time. Each video guided participants through exercises designed to manage anxiety and depression symptoms, such as progressive muscle relaxation and problem-solving strategies. The videos were categorized into modules including Actions, Mental Hygiene, Exposure, Acceptance, Cognitions, Regulation and Positive Feelings, and Preparation. The app also included optional daily prompts on mood and anxiety, adapted from the PANAS-X, to encourage self-monitoring.
|
Wait List Control Condition
n=31 Participants
The wait list control condition will not receive the digital intervention treatment for the duration of the study. They will still provide urine samples during the study. Participants assigned to this condition will be able to access the digital intervention after their participation in the study.
|
|---|---|---|
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Change in Depressive Symptoms as Assessed by Patient Health Questionnaire-9
pre-post
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-4.03 units on a scale
Interval -9.07 to 1.0
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-2.65 units on a scale
Interval -8.34 to 3.04
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Change in Depressive Symptoms as Assessed by Patient Health Questionnaire-9
pre-followup
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-5.36 units on a scale
Interval -11.29 to 0.57
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-1.45 units on a scale
Interval -5.73 to 2.84
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PRIMARY outcome
Timeframe: From Baseline to 4 weeks (post-intervention) and from Baseline to 8 weeks (follow-up).This outcome measures the change in the likelihood of a positive urine drug screen (UDS) for opioids (MOP). The result of each UDS was coded as a binary variable (0 = negative test, 1 = positive test). The reported data are the beta coefficients (estimated mean change) from a robust linear mixed-effects model, which are presented on a unitless scale. A negative value indicates a reduction in the likelihood of testing positive and represents a better outcome.
Outcome measures
| Measure |
Smartphone Digital Intervention Group (Experimental Group)
n=32 Participants
Participants in the smartphone digital intervention group downloaded the "Mood Triggers" application and were asked to engage with the intervention four to six times per week for four weeks, completing 20 brief (\~2 minute) CBT-based video sessions. The app passively collected data on ambient light, GPS location, call/text logs, and screen time. Each video guided participants through exercises designed to manage anxiety and depression symptoms, such as progressive muscle relaxation and problem-solving strategies. The videos were categorized into modules including Actions, Mental Hygiene, Exposure, Acceptance, Cognitions, Regulation and Positive Feelings, and Preparation. The app also included optional daily prompts on mood and anxiety, adapted from the PANAS-X, to encourage self-monitoring.
|
Wait List Control Condition
n=31 Participants
The wait list control condition will not receive the digital intervention treatment for the duration of the study. They will still provide urine samples during the study. Participants assigned to this condition will be able to access the digital intervention after their participation in the study.
|
|---|---|---|
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Change in Likelihood of a Positive Urine Screen for Opioids (MOP)
pre-post
|
-0.71 beta coefficient
Interval -1.81 to 0.39
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0.33 beta coefficient
Interval -1.29 to 1.94
|
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Change in Likelihood of a Positive Urine Screen for Opioids (MOP)
pre-followup
|
-0.62 beta coefficient
Interval -1.83 to 0.59
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1.09 beta coefficient
Interval -0.74 to 2.92
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SECONDARY outcome
Timeframe: From Baseline to 4 weeks (post-intervention) and from Baseline to 8 weeks (follow-up).The Rapid Opioid Dependence Screen (RODS) is an 8-item measure used to assess opioid dependence severity. For this study, a total score was calculated by summing two components: 1) The number of endorsed opioid types from Item 1 (which lists 8 types, range 0-8), and 2) The number of "yes" responses to the 7 dependence-related questions in Items 2-8 (range 0-7). This method results in a total possible score range of 0 to 15. Higher scores indicate a greater breadth of lifetime opioid use and a higher number of dependence symptoms. A reduction in score represents improvement.
Outcome measures
| Measure |
Smartphone Digital Intervention Group (Experimental Group)
n=32 Participants
Participants in the smartphone digital intervention group downloaded the "Mood Triggers" application and were asked to engage with the intervention four to six times per week for four weeks, completing 20 brief (\~2 minute) CBT-based video sessions. The app passively collected data on ambient light, GPS location, call/text logs, and screen time. Each video guided participants through exercises designed to manage anxiety and depression symptoms, such as progressive muscle relaxation and problem-solving strategies. The videos were categorized into modules including Actions, Mental Hygiene, Exposure, Acceptance, Cognitions, Regulation and Positive Feelings, and Preparation. The app also included optional daily prompts on mood and anxiety, adapted from the PANAS-X, to encourage self-monitoring.
|
Wait List Control Condition
n=31 Participants
The wait list control condition will not receive the digital intervention treatment for the duration of the study. They will still provide urine samples during the study. Participants assigned to this condition will be able to access the digital intervention after their participation in the study.
|
|---|---|---|
|
Change in Opioid Use Disorder Severity as Measured by the Rapid Opioid Dependence Screen (RODS)
pre-post
|
-5.23 units on a scale
Interval -6.37 to -4.1
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-5.56 units on a scale
Interval -6.96 to -4.15
|
|
Change in Opioid Use Disorder Severity as Measured by the Rapid Opioid Dependence Screen (RODS)
pre-followup
|
-4.72 units on a scale
Interval -6.36 to -3.08
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-4.29 units on a scale
Interval -7.54 to -1.03
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SECONDARY outcome
Timeframe: From Baseline to 4 weeks (post-intervention) and from Baseline to 8 weeks (follow-up).Opioid Craving Scale (OCS) is a 3-item self-report measure used to assess opioid craving. Each of the three items is rated on a scale from 0 to 9. The total score is calculated by taking the average of the three item scores, resulting in a final score range of 0 to 9. Higher scores indicate a greater severity of craving. A reduction in score represents improvement.
Outcome measures
| Measure |
Smartphone Digital Intervention Group (Experimental Group)
n=32 Participants
Participants in the smartphone digital intervention group downloaded the "Mood Triggers" application and were asked to engage with the intervention four to six times per week for four weeks, completing 20 brief (\~2 minute) CBT-based video sessions. The app passively collected data on ambient light, GPS location, call/text logs, and screen time. Each video guided participants through exercises designed to manage anxiety and depression symptoms, such as progressive muscle relaxation and problem-solving strategies. The videos were categorized into modules including Actions, Mental Hygiene, Exposure, Acceptance, Cognitions, Regulation and Positive Feelings, and Preparation. The app also included optional daily prompts on mood and anxiety, adapted from the PANAS-X, to encourage self-monitoring.
|
Wait List Control Condition
n=31 Participants
The wait list control condition will not receive the digital intervention treatment for the duration of the study. They will still provide urine samples during the study. Participants assigned to this condition will be able to access the digital intervention after their participation in the study.
|
|---|---|---|
|
Change in Opioid Craving as Measured by the Opioid Craving Scale (OCS)
pre-post
|
0.46 units on a scale
Interval -1.04 to 1.96
|
-1.83 units on a scale
Interval -4.87 to 1.19
|
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Change in Opioid Craving as Measured by the Opioid Craving Scale (OCS)
pre-followup
|
0.06 units on a scale
Interval -2.25 to 2.36
|
-1.61 units on a scale
Interval -4.38 to 1.16
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Adverse Events
Smartphone Digital Intervention Group (Experimental Group)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Wait List Control 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