Clinical trial NCT05047627: Digital Intervention to Treat Anxiety and Depression Among Persons Receiving Treatment for Opioid Use Disorder
Official title: Digital Intervention to Treat Anxiety and Depression Among Persons Receiving Treatment for Opioid Use Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-use Disorder
Anxiety Disorders
Depressive Disorder
Lead sponsor: Trustees of Dartmouth College
Sponsor class: OTHER
First posted: 2021-09-17
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: Change in anxiety symptoms as assessed by Generalized Anxiety Disorder- Q-IV Scale
timeFrame: at baseline, up to 3 days after enrollment
measure: Change in anxiety symptoms as assessed by Generalized Anxiety Disorder- Q-IV Scale
timeFrame: 4 weeks after enrollment
measure: Change in anxiety symptoms as assessed by Generalized Anxiety Disorder- Q-IV Scale
timeFrame: 8 weeks from enrollment
measure: Change in depressive symptoms as assessed by Patient Health Questionnaire-9
timeFrame: at baseline, up to 3 days after enrollment
measure: Change in depressive symptoms as assessed by Patient Health Questionnaire-9
timeFrame: 4 weeks after enrollment
measure: Change in depressive symptoms as assessed by Patient Health Questionnaire-9
timeFrame: 8 weeks from enrollment
measure: Positive Test for Opioids
timeFrame: at baseline, up to 3 days after enrollment
measure: Positive Test for Opioids
timeFrame: 2 weeks after enrollment
measure: Positive Test for Opioids
timeFrame: 4 weeks after enrollment
measure: Positive Test for Opioids
timeFrame: 6 weeks after enrollment
measure: Positive Test for Opioids
timeFrame: 8 weeks after enrollment
Secondary outcomes:
measure: Opioid Dependency using the Rapid Opioid Dependence Screen
timeFrame: at baseline, up to 3 days after enrollment
measure: Opioid Dependency using the Opioid Craving Scale
timeFrame: at baseline, up to 3 days after enrollment
measure: Difficulties in emotion regulation using the Modified Difficulties in Emotion Regulation Scale (DERS)
timeFrame: at baseline, up to 3 days after enrollment
measure: Difficulties in emotion regulation using the Modified Difficulties in Emotion Regulation Scale (DERS)
timeFrame: 4 weeks after enrollment
measure: Difficulties in emotion regulation using the Modified Difficulties in Emotion Regulation Scale (DERS)
timeFrame: 8 weeks after enrollment
measure: Self Regulation Scale
timeFrame: at baseline, up to 3 days after enrollment
measure: Self Regulation Scale
timeFrame: 4 weeks after enrollment
measure: Self Regulation Scale
timeFrame: 8 weeks after enrollment
measure: Estimates of Activities
timeFrame: 56 days (or 8-weeks)
measure: Estimates of sociability
timeFrame: 56 days (or 8-weeks)
measure: Estimates of Light Exposure
timeFrame: 56 days (or 8-weeks)
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Center For Technology and Behavioral Health
state: New Hampshire
Study officials:
affiliation: Dartmouth College
name: Nicholas C Jacobson, PhD
role: PRINCIPAL_INVESTIGATOR
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