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

Anxiety Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05047627
• Other study ID #: AWD00010555
• Status: Completed
• Phase: N/A
• Start date: September 15, 2021
• Est. completion date: March 1, 2023

Study information

• Verified date: March 2023
• Source: Trustees of Dartmouth College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: March 1, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Depressive Disorder
• Disease
• Opioid-Related Disorders
• Opioid-use Disorder
• Substance-Related Disorders

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Center For Technology and Behavioral Health	Lebanon	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Trustees of Dartmouth College

Country where clinical trial is conducted

United States, 

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* Note: There are 34 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Positive Test for Opioids	urine tests will detect substance use in participants	at baseline, up to 3 days after enrollment
Primary	Positive Test for Opioids	urine tests will detect substance use in participants	2 weeks after enrollment
Primary	Positive Test for Opioids	urine tests will detect substance use in participants	4 weeks after enrollment
Primary	Positive Test for Opioids	urine tests will detect substance use in participants	6 weeks after enrollment
Primary	Positive Test for Opioids	urine tests will detect substance use in participants	8 weeks after enrollment
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Estimates of Activities	Use mobile sensor and phone utilization data to develop individualized estimates of activities.	56 days (or 8-weeks)
Secondary	Estimates of sociability	Use mobile sensor and phone utilization data to develop individualized estimates of sociability	56 days (or 8-weeks)
Secondary	Estimates of Light Exposure	Use mobile sensor and phone utilization data to develop individualized estimates of light exposure.	56 days (or 8-weeks)