N/A
N=63
Digital Intervention to Treat Anxiety and Depression Among Persons Receiving Treatment for Opioid Use Disorder
Opioid-use Disorder · Anxiety Disorders · Depressive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT05047627 ↗Enrolled (actual)
63
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcome: Primary: Change in Anxiety Symptoms as Assessed by Generalized Anxiety Disorder- Q-IV Scale — -1.8; -1.04; -2.47; -1.53 units on a scale — p=.755
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Smartphone-Based Digital Intervention (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Trustees of Dartmouth College
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Anxiety Symptoms as Assessed by Generalized Anxiety Disorder- Q-IV Scale |
-1.8; -1.04; -2.47; -1.53 | .755 |
| PRIMARY Change in Depressive Symptoms as Assessed by Patient Health Questionnaire-9 |
-4.03; -2.65; -5.36; -1.45 | 0.713 |
| PRIMARY Change in Likelihood of a Positive Urine Screen for Opioids (MOP) |
-0.71; 0.33; -0.62; 1.09 | 0.323 |
| SECONDARY Change in Opioid Use Disorder Severity as Measured by the Rapid Opioid Dependence Screen (RODS) |
-5.23; -5.56; -4.72; -4.29 | .692 |
| SECONDARY Change in Opioid Craving as Measured by the Opioid Craving Scale (OCS) |
0.46; -1.83; 0.06; -1.61 | 0.1 |
Summary
The majority of opioid users meet criteria for anxiety and depressive disorders, but most substance use disorder treatment programs do not offer treatment for co-occurring mental health problems. Anxiety and depression may also be directly linked to opioid use itself. Although treatments have been developed for anxiety and depressive symptoms for opioid users within face-to-face settings, few treatment facilities offer these in-person interventions due to their high cost and time burden. Given the deficits in research on treatments for anxiety and depression among those with opioid use disorder, the current research will examine the efficacy of a digital intervention designed to treat anxiety and depressive symptoms by augmenting the state of the science medication-based opioid use disorder treatment. Over the course of the proposed study, the research team will design and test the feasibility and acceptability of a standalone mobile intervention designed to treat persons receiving medication treatment for opioid use disorder. Participants receiving medication treatment for opioid use disorder will be randomized to receive a digital intervention to treat anxiety and depression or care as usual for a total of four weeks. The overarching goal of the proposed work is to test the feasibility and acceptability of the proposed mobile intervention. The Investigators will also explore the preliminary efficacy by examining reductions in anxiety and depressive symptoms and opioid cravings and use. This work could lead to a low-cost scalable solution to augment gold-standard treatment as usual in opioid use disorder by decreasing levels of comorbidity of anxiety and depressive disorders, thereby ultimately improving the outcomes of opioid use disorder itself.
Eligibility Criteria
Inclusion Criteria
- Adults (age 18 or older)
- fluent in English
- able to provide informed consent
- meet current criteria for OUD (as defined by a Rapid Opioid Dependence Screen)
- are receiving methadone, buprenorphine, and/or naltrexone for OUD
- meet current criteria for an anxiety and/or depressive disorder (based on the Patient Health Questionnaire and the Generalized Anxiety Disorder Questionnaire).
Exclusion Criteria
- active suicidality
- psychosis
- bipolar disorder
Data sourced from ClinicalTrials.gov (NCT05047627). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.