Digital Intervention to Treat Anxiety and Depression Among Persons Receiving Treatment for Opioid Use Disorder

Study Overview
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Brief Summary
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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.

Detailed Description
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The study team will recruit a population of 60 adults who are receiving medication treatment for OUD from an online study based on Google Adwords, Reddit, and Facebook advertisements as online recruitment has been shown to be a viable and cost-effective recruitment method for opioid users. The total sample size may be expanded if recruitment costs are lower than expected. Participants will complete self-report assessments on their anxiety symptoms, depressive symptoms, opioid cravings, and opioid use behaviors. Participants will be randomized to a smartphone-based digital intervention or waitlist control condition. The digital intervention will be designed to treat participants' anxiety and depressive symptoms, and participants will be asked to use the intervention four times per week for four weeks (16 digital sessions).The smartphone intervention will also collect passive sensing data continuously during the 4 week period. Participants will complete post measures and one-month follow-up measures on anxiety symptoms, depressive symptoms, opioid cravings, and opioid use behaviors. The urine drug screen will be mailed to participants. Participants will also be asked to complete five urine tests to detect substance use (amphetamines, barbiturates, benzodiazepines, cocaine, ecstasy, marijuana, methamphetamine, opioids, oxycodone, and pcp) across the study (1 at pre-digital intervention, 1 during the digital intervention, 1 post-digital intervention, 1 between post and follow-up of the digital intervention, and 1 at the 1-month follow-up of the digital intervention). Participants will be instructed when to complete each urine test and will be asked to take a photo of the back the label of each test showing the results to the experimenters and to text these photos to a Google Voice Number maintained by the experimenters. Thus, this proposal seeks to address a crucial deficit in the availability of treatments for anxiety and depressive disorders among persons with OUD to ultimately augment treatment for OUD.

Official Title
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Digital Intervention to Treat Anxiety and Depression Among Persons Receiving Treatment for Opioid Use Disorder

Conditions
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Opioid-use Disorder, Anxiety Disorders, Depressive Disorder

Intervention / Treatment
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* Behavioral: Smartphone-Based Digital Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Smartphone Digital Intervention Group<br>The Smartphone Digital Intervention Group is the experimental group. Participants randomized to this group will download the smartphone intervention and be asked to use the intervention four times per week for four weeks ( 16 digital sessions). The smartphone digital intervention will also continuously collect passive sensing data. The smartphone digital intervention will be designed to treat anxiety and depression by providing informational videos to help participants treat these symptoms. These videos include information about physical activity, muscle relaxation, and other proven helpful interventions to help with anxiety and depression. | Behavioral: Smartphone-Based Digital Intervention<br>* The digital intervention will be a prototype, and the current trial will be used to continue to both develop and refine the intervention. The current intervention will be based on a combination of cognitive-behavioral principles. As with prior research, the mobile platform will be delivered via Qualtrics, a HIPAA compliant and mobile-friendly platform. The cognitive-behavioral therapy will be primarily based on components with strongest support in digital interventions. The app will continuously collect passive sensing data on patterns in 1) sleep duration and quality;(2) light (3) location; (4) movement (5) social contact including duration and frequency of incoming and outcoming calls and text messages; (6) screen time; and (7) heart rate variability; (8) sound levels captured through passively collected smartphone The platform will deliver interactive interventions where participants will view texts and images, and it will also allow user interaction.<br>|
| No Intervention: Wait list Control Condition<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in anxiety symptoms as assessed by Generalized Anxiety Disorder- Q-IV Scale | Assesses anxiety symptoms. Possible GAD-Q-IV scores range from 0 to 12, with higher scores representing greater GAD symptom severity | at baseline, up to 3 days after enrollment | 
| Change in anxiety symptoms as assessed by Generalized Anxiety Disorder- Q-IV Scale | Assesses anxiety symptoms. Possible GAD-Q-IV scores range from 0 to 12, with higher scores representing greater GAD symptom severity | 4 weeks after enrollment | 
| Change in anxiety symptoms as assessed by Generalized Anxiety Disorder- Q-IV Scale | Assesses anxiety symptoms. Possible GAD-Q-IV scores range from 0 to 12, with higher scores representing greater GAD symptom severity | 8 weeks from enrollment | 
| Change in depressive symptoms as assessed by Patient Health Questionnaire-9 | 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) | at baseline, up to 3 days after enrollment | 
| Change in depressive symptoms as assessed by Patient Health Questionnaire-9 | 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) | 4 weeks after enrollment | 
| Change in depressive symptoms as assessed by Patient Health Questionnaire-9 | 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) | 8 weeks from enrollment | 
| Positive Test for Opioids | urine tests will detect substance use in participants | at baseline, up to 3 days after enrollment | 
| Positive Test for Opioids | urine tests will detect substance use in participants | 2 weeks after enrollment | 
| Positive Test for Opioids | urine tests will detect substance use in participants | 4 weeks after enrollment | 
| Positive Test for Opioids | urine tests will detect substance use in participants | 6 weeks after enrollment | 
| Positive Test for Opioids | urine tests will detect substance use in participants | 8 weeks after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid Dependency using the Rapid Opioid Dependence Screen | The RODS is an eight-item questionnaire inquiring about tolerance; withdrawal; unintended dosage or duration of use; persistent desire and unsuccessful quit attempts; time spent obtaining using and recovering from opioid use. | at baseline, up to 3 days after enrollment | 
| Opioid Dependency using the Opioid Craving Scale | The Opioid Craving Scale measures opioid cravings using three questions: (1) How much do you currently crave opiates (0 Not at all - 10 Extremely). | at baseline, up to 3 days after enrollment | 
| Difficulties in emotion regulation using the Modified Difficulties in Emotion Regulation Scale (DERS) | Measures difficulties in emotion regulation with 21 items and a 5 point Likert scale (1 almost never - 5 almost always) | at baseline, up to 3 days after enrollment | 
| Difficulties in emotion regulation using the Modified Difficulties in Emotion Regulation Scale (DERS) | Measures difficulties in emotion regulation with 21 items and a 5 point Likert scale (1 almost never - 5 almost always) | 4 weeks after enrollment | 
| Difficulties in emotion regulation using the Modified Difficulties in Emotion Regulation Scale (DERS) | Measures difficulties in emotion regulation with 21 items and a 5 point Likert scale (1 almost never - 5 almost always) | 8 weeks after enrollment | 
| Self Regulation Scale | 12-item momentary self-regulation scale that can capture self-regulatory dynamics at a momentary level using a 5 point scale (1 not at all- 5 extremely) | at baseline, up to 3 days after enrollment | 
| Self Regulation Scale | 12-item momentary self-regulation scale that can capture self-regulatory dynamics at a momentary level using a 5 point scale (1 not at all- 5 extremely) | 4 weeks after enrollment | 
| Self Regulation Scale | 12-item momentary self-regulation scale that can capture self-regulatory dynamics at a momentary level using a 5 point scale (1 not at all- 5 extremely) | 8 weeks after enrollment | 
| Estimates of Activities | Use mobile sensor and phone utilization data to develop individualized estimates of activities. | 56 days (or 8-weeks) | 
| Estimates of sociability | Use mobile sensor and phone utilization data to develop individualized estimates of sociability | 56 days (or 8-weeks) | 
| Estimates of Light Exposure | Use mobile sensor and phone utilization data to develop individualized estimates of light exposure. | 56 days (or 8-weeks) |