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

Trustees of Dartmouth College

Status: Completed

Conditions: Opioid-use Disorder; Anxiety Disorders; Depressive Disorder

Treatments: Behavioral: Smartphone-Based Digital Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05047627

AWD00010555

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 63 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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63 participants in 2 patient groups

Smartphone Digital Intervention Group

Experimental group

Description:

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.

Treatment:

Behavioral: Smartphone-Based Digital Intervention

Wait list Control Condition

No Intervention group

Description:

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.