Anxiety Disorders Clinical Trial
Official title:
Digital Intervention to Treat Anxiety and Depression Among Persons Receiving Treatment for Opioid Use Disorder
Verified date | March 2023 |
Source | Trustees of Dartmouth College |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Center For Technology and Behavioral Health | Lebanon | New Hampshire |
Lead Sponsor | Collaborator |
---|---|
Trustees of Dartmouth College |
United States,
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* Note: There are 34 references in all — Click here to view all references
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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