Digital Intervention to Treat Anxiety and Depression Among Persons Receiving Treatment for Opioid Use Disorder
NCT ID: NCT05047627
Last Updated: 2025-11-05
Study Results
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View full resultsBasic Information
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COMPLETED
NA
63 participants
INTERVENTIONAL
2021-09-15
2023-03-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Smartphone Digital Intervention Group
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.
Smartphone-Based Digital Intervention
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.
Wait list Control Condition
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.
No interventions assigned to this group
Interventions
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Smartphone-Based Digital Intervention
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* psychosis
* bipolar disorder
18 Years
ALL
No
Sponsors
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Trustees of Dartmouth College
OTHER
Responsible Party
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Nicholas Jacobson
Principal Investigator
Principal Investigators
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Nicholas C Jacobson, PhD
Role: PRINCIPAL_INVESTIGATOR
Dartmouth College
Locations
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Center For Technology and Behavioral Health
Lebanon, New Hampshire, United States
Countries
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References
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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AWD00010555
Identifier Type: -
Identifier Source: org_study_id
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