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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05047627
Other study ID # AWD00010555
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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, 

References & Publications (34)

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Hassan AN, Howe AS, Samokhvalov AV, Le Foll B, George TP. Management of mood and anxiety disorders in patients receiving opioid agonist therapy: Review and meta-analysis. Am J Addict. 2017 Sep;26(6):551-563. doi: 10.1111/ajad.12581. Epub 2017 Jul 4. — View Citation

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Kosten TR, Rounsaville BJ, Kleber HD. A 2.5-year follow-up of depression, life crises, and treatment effects on abstinence among opioid addicts. Arch Gen Psychiatry. 1986 Aug;43(8):733-8. doi: 10.1001/archpsyc.1986.01800080019003. — View Citation

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Kroenke, Kurt, & Spitzer, R. L. (2002). The PHQ-9: A new depression diagnostic and severity measure. Psychiatric Annals, 32(9), 509-515. https://doi.org/10.3928/0048-5713-20020901-06

Krupnick JL, Green BL, Amdur R, Alaoui A, Belouali A, Roberge E, Cueva D, Roberts M, Melnikoff E, Dutton MA. An Internet-based writing intervention for PTSD in veterans: A feasibility and pilot effectiveness trial. Psychol Trauma. 2017 Jul;9(4):461-470. doi: 10.1037/tra0000176. Epub 2016 Sep 8. — View Citation

Lange A, Rietdijk D, Hudcovicova M, van de Ven JP, Schrieken B, Emmelkamp PM. Interapy: a controlled randomized trial of the standardized treatment of posttraumatic stress through the internet. J Consult Clin Psychol. 2003 Oct;71(5):901-9. doi: 10.1037/0022-006X.71.5.901. — View Citation

Levin ME, Navarro C, Cruz RA, Haeger J. Comparing in-the-moment skill coaching effects from tailored versus non-tailored acceptance and commitment therapy mobile apps in a non-clinical sample. Cogn Behav Ther. 2019 May;48(3):200-216. doi: 10.1080/16506073.2018.1503706. Epub 2018 Aug 17. — View Citation

Maloney E, Degenhardt L, Darke S, Nelson EC. Are non-fatal opioid overdoses misclassified suicide attempts? Comparing the associated correlates. Addict Behav. 2009 Sep;34(9):723-9. doi: 10.1016/j.addbeh.2009.04.011. Epub 2009 May 3. — View Citation

Marshall BDL, Green TC, Elston B, Yedinak JL, Hadland SE, Clark MA. The Effectiveness of Internet- and Field-Based Methods to Recruit Young Adults Who Use Prescription Opioids Nonmedically. Subst Use Misuse. 2018 Aug 24;53(10):1688-1699. doi: 10.1080/10826084.2018.1425725. Epub 2018 Jan 24. — View Citation

McHugh RK, Fitzmaurice GM, Carroll KM, Griffin ML, Hill KP, Wasan AD, Weiss RD. Assessing craving and its relationship to subsequent prescription opioid use among treatment-seeking prescription opioid dependent patients. Drug Alcohol Depend. 2014 Dec 1;145:121-6. doi: 10.1016/j.drugalcdep.2014.10.002. Epub 2014 Oct 16. — View Citation

Moore MT, Anderson NL, Barnes JM, Haigh EA, Fresco DM. Using the GAD-Q-IV to identify generalized anxiety disorder in psychiatric treatment seeking and primary care medical samples. J Anxiety Disord. 2014 Jan;28(1):25-30. doi: 10.1016/j.janxdis.2013.10.009. Epub 2013 Nov 20. — View Citation

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* Note: There are 34 references in allClick 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)
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