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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05047627
Recruitment Status : Recruiting
First Posted : September 17, 2021
Last Update Posted : October 15, 2021
Sponsor:
Information provided by (Responsible Party):
Nicholas Jacobson, Trustees of Dartmouth College

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.

Condition or disease Intervention/treatment Phase
Opioid-use Disorder Anxiety Disorders Depressive Disorder Behavioral: Smartphone-Based Digital Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Digital Intervention to Treat Anxiety and Depression Among Persons Receiving Treatment for Opioid Use Disorder
Actual Study Start Date : September 15, 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: 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.
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.

No Intervention: 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.



Primary Outcome Measures :
  1. Change in anxiety symptoms as assessed by Generalized Anxiety Disorder- Q-IV Scale [ Time Frame: at baseline, up to 3 days after enrollment ]
    Assesses anxiety symptoms. Possible GAD-Q-IV scores range from 0 to 12, with higher scores representing greater GAD symptom severity

  2. Change in anxiety symptoms as assessed by Generalized Anxiety Disorder- Q-IV Scale [ Time Frame: 4 weeks after enrollment ]
    Assesses anxiety symptoms. Possible GAD-Q-IV scores range from 0 to 12, with higher scores representing greater GAD symptom severity

  3. Change in anxiety symptoms as assessed by Generalized Anxiety Disorder- Q-IV Scale [ Time Frame: 8 weeks from enrollment ]
    Assesses anxiety symptoms. Possible GAD-Q-IV scores range from 0 to 12, with higher scores representing greater GAD symptom severity

  4. Change in depressive symptoms as assessed by Patient Health Questionnaire-9 [ Time Frame: at baseline, up to 3 days after enrollment ]
    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)

  5. Change in depressive symptoms as assessed by Patient Health Questionnaire-9 [ Time Frame: 4 weeks after enrollment ]
    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)

  6. Change in depressive symptoms as assessed by Patient Health Questionnaire-9 [ Time Frame: 8 weeks from enrollment ]
    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)

  7. Positive Test for Opioids [ Time Frame: at baseline, up to 3 days after enrollment ]
    urine tests will detect substance use in participants

  8. Positive Test for Opioids [ Time Frame: 2 weeks after enrollment ]
    urine tests will detect substance use in participants

  9. Positive Test for Opioids [ Time Frame: 4 weeks after enrollment ]
    urine tests will detect substance use in participants

  10. Positive Test for Opioids [ Time Frame: 6 weeks after enrollment ]
    urine tests will detect substance use in participants

  11. Positive Test for Opioids [ Time Frame: 8 weeks after enrollment ]
    urine tests will detect substance use in participants


Secondary Outcome Measures :
  1. Opioid Dependency using the Rapid Opioid Dependence Screen [ Time Frame: at baseline, up to 3 days after enrollment ]
    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.

  2. Opioid Dependency using the Opioid Craving Scale [ Time Frame: at baseline, up to 3 days after enrollment ]
    The Opioid Craving Scale measures opioid cravings using three questions: (1) "How much do you currently crave opiates" (0 Not at all - 10 Extremely).

  3. Difficulties in emotion regulation using the Modified Difficulties in Emotion Regulation Scale (DERS) [ Time Frame: at baseline, up to 3 days after enrollment ]
    Measures difficulties in emotion regulation with 21 items and a 5 point Likert scale (1 almost never - 5 almost always)

  4. Difficulties in emotion regulation using the Modified Difficulties in Emotion Regulation Scale (DERS) [ Time Frame: 4 weeks after enrollment ]
    Measures difficulties in emotion regulation with 21 items and a 5 point Likert scale (1 almost never - 5 almost always)

  5. Difficulties in emotion regulation using the Modified Difficulties in Emotion Regulation Scale (DERS) [ Time Frame: 8 weeks after enrollment ]
    Measures difficulties in emotion regulation with 21 items and a 5 point Likert scale (1 almost never - 5 almost always)

  6. Self Regulation Scale [ Time Frame: at baseline, up to 3 days after enrollment ]
    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)

  7. Self Regulation Scale [ Time Frame: 4 weeks after enrollment ]
    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. Self Regulation Scale [ Time Frame: 8 weeks after enrollment ]
    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)

  9. Estimates of Sleep [ Time Frame: 56 days (or 8-weeks) ]
    Use mobile sensor and phone utilization data to develop individualized estimates of sleep.

  10. Estimates of Activities [ Time Frame: 56 days (or 8-weeks) ]
    Use mobile sensor and phone utilization data to develop individualized estimates of activities.

  11. Estimates of sociability [ Time Frame: 56 days (or 8-weeks) ]
    Use mobile sensor and phone utilization data to develop individualized estimates of sociability

  12. Estimates of Light Exposure [ Time Frame: 56 days (or 8-weeks) ]
    Use mobile sensor and phone utilization data to develop individualized estimates of light exposure.

  13. Estimates of Screen Time [ Time Frame: 56 days (or 8-weeks) ]
    Use mobile sensor and phone utilization data to develop individualized estimates of screen time.

  14. Estimates of Heart Rate Variability [ Time Frame: 56 days (or 8-weeks) ]
    Use mobile sensor and phone utilization data to develop individualized estimates of heart rate variability

  15. Estimates of Sound Levels [ Time Frame: 56 days (or 8-weeks) ]
    Use mobile sensor and phone utilization data to develop individualized estimates of sound levels.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05047627


Contacts
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Contact: Natalie X Thomas, B.S. 4109134746 natalie.thomas@dartmouth.edu

Locations
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United States, New Hampshire
Center For Technology and Behavioral Health Recruiting
Lebanon, New Hampshire, United States, 03766
Contact: Nicholas C Jacobson    603-646-7037    Nicholas.C.Jacobson@dartmouth.edu   
Principal Investigator: Nicholas C Jacobson, PhD         
Sponsors and Collaborators
Trustees of Dartmouth College
Investigators
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Principal Investigator: Nicholas C Jacobson, PhD Dartmouth College
Publications:
Blume, A. W., Schmaling, K. B., & Marlatt, G. A. (2000). Revisiting the self-medication hypothesis from a behavioral perspective. Cognitive and Behavioral Practice, 7(4), 379-384. https://doi.org/10.1016/S1077-7229(00)80048-6
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
Newman, M. G., Zuellig, A. R., Kachin, K. E., Constantino, M. J., Przeworski, A., Erickson, T., & Cashman-McGrath, L. (2002). Preliminary reliability and validity of the Generalized Anxiety Disorder Questionnaire-IV: A revised self-report diagnostic measure of generalized anxiety disorder. Behavior Therapy, 33(2), 215-233. https://doi.org/10.1016/S0005-7894(02)80026-0
Gratz, K.L., Roemer, L. Multidimensional Assessment of Emotion Regulation and Dysregulation: Development, Factor Structure, and Initial Validation of the Difficulties in Emotion Regulation Scale. J Psychopathol Behav Assess 30, 315 (2008). https://doi.org/10.1007/s10862-008-9102-4

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Responsible Party: Nicholas Jacobson, Principal Investigator, Trustees of Dartmouth College
ClinicalTrials.gov Identifier: NCT05047627    
Other Study ID Numbers: AWD00010555
First Posted: September 17, 2021    Key Record Dates
Last Update Posted: October 15, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disease
Opioid-Related Disorders
Substance-Related Disorders
Anxiety Disorders
Depressive Disorder
Pathologic Processes
Mental Disorders
Mood Disorders
Narcotic-Related Disorders
Chemically-Induced Disorders