Trial results for a study investigating a digital intervention to treat Anxiety and Depressive Disorders among persons receiving treatment for Opioid-use Disorder were posted on ClinicalTrials.gov on 2025-11-05. The study enrolled 63 participants.
Background
The majority of individuals with opioid use disorder (OUD) also meet criteria for co-occurring anxiety and depressive disorders. However, many substance use disorder treatment programs do not offer comprehensive treatment for these co-occurring mental health problems. Anxiety and depression can also be directly linked to opioid use itself, complicating recovery. While face-to-face interventions for anxiety and depressive symptoms have been developed for opioid users, their high cost and time burden often limit their availability in treatment facilities. This highlights a critical need for accessible and effective treatments for anxiety and depression in this population, such as digital interventions.
Trial design
This completed study, designated as Phase NA, enrolled 63 participants to investigate conditions including Opioid-use Disorder, Anxiety Disorders, and Depressive Disorder. The trial compared a Smartphone Digital Intervention Group (Experimental Group) against a Wait List Control Condition. The intervention aimed to address anxiety and depressive symptoms among persons receiving treatment for opioid use disorder.
Key results
The trial reported several key measurements related to changes in anxiety, depressive symptoms, and opioid use:
- Change in Anxiety Symptoms as Assessed by Generalized Anxiety Disorder- Q-IV Scale (units on a scale):
- Smartphone Digital Intervention Group (Experimental Group): Mean change of -1.8.
- Wait List Control Condition: Mean change of -1.04.
- Smartphone Digital Intervention Group (Experimental Group): Mean change of -2.47.
- Wait List Control Condition: Mean change of -1.53.
- Change in Depressive Symptoms as Assessed by Patient Health Questionnaire-9 (units on a scale):
- Smartphone Digital Intervention Group (Experimental Group): Mean change of -4.03.
- Wait List Control Condition: Mean change of -2.65.
- Smartphone Digital Intervention Group (Experimental Group): Mean change of -5.36.
- Wait List Control Condition: Mean change of -1.45.
- Change in Likelihood of a Positive Urine Screen for Opioids (MOP) (beta coefficient):
- Smartphone Digital Intervention Group (Experimental Group): Mean change of -0.71.
- Wait List Control Condition: Mean change of 0.33.
- Smartphone Digital Intervention Group (Experimental Group): Mean change of -0.62.
- Wait List Control Condition: Mean change of 1.09.
Key analyses using robust linear mixed models for differences in slopes between groups showed:
- A difference in slopes of 0.76 (95% CI: -4.14 to 5.66) with a p-value of 0.755.
- A difference in slopes of 1.38 (95% CI: -6.15 to 8.91) with a p-value of 0.713.
- A difference in slopes of 1.03 (95% CI: -1.02 to 3.09) with a p-value of 0.323.
- A difference in slopes of -0.33 (95% CI: -1.95 to 1.3) with a p-value of 0.692.
- A difference in slopes of -2.92 (95% CI: -6.41 to 0.58) with a p-value of 0.1.
What this means
The trial results indicate that the smartphone digital intervention group experienced numerically greater mean reductions in both anxiety and depressive symptoms compared to the wait list control group. For instance, the experimental group showed mean depressive symptom reductions of -4.03 and -5.36, versus -2.65 and -1.45 in the control group. Similarly, for anxiety symptoms, the experimental group had mean reductions of -1.8 and -2.47, compared to -1.04 and -1.53 in the control. The digital intervention group also showed a negative mean change in the likelihood of a positive urine screen for opioids, while the control group showed positive mean changes. However, the robust linear mixed models analyzing the differences in slopes between the groups generally yielded high p-values (e.g., 0.755, 0.713, 0.323, 0.692, 0.1), suggesting that the observed differences in the rate of change for these outcomes between the intervention and control groups were not statistically significant.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05047627, titled "Digital Intervention to Treat Anxiety and Depression Among Persons Receiving Treatment for Opioid Use Disorder", were posted on 2025-11-05 on clinicaltrials.gov.