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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05047627

Enrollment

Registered

2021-09-17

Start date

2021-09-15

Completion date

2023-03-01

Last updated

2025-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety Disorders, Depressive Disorder, Opioid-use Disorder

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.

Interventions

BEHAVIORALSmartphone-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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change in Anxiety Symptoms as Assessed by Generalized Anxiety Disorder- Q-IV Scale	From Baseline to 4 weeks (post-intervention) and from Baseline to 8 weeks (follow-up).	Assesses anxiety symptoms. Possible GAD-Q-IV scores range from 0 to 12, with higher scores representing greater GAD symptom severity
Change in Depressive Symptoms as Assessed by Patient Health Questionnaire-9	From Baseline to 4 weeks (post-intervention) and from Baseline to 8 weeks (follow-up).	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)
Change in Likelihood of a Positive Urine Screen for Opioids (MOP)	From Baseline to 4 weeks (post-intervention) and from Baseline to 8 weeks (follow-up).	This outcome measures the change in the likelihood of a positive urine drug screen (UDS) for opioids (MOP). The result of each UDS was coded as a binary variable (0 = negative test, 1 = positive test). The reported data are the beta coefficients (estimated mean change) from a robust linear mixed-effects model, which are presented on a unitless scale. A negative value indicates a reduction in the likelihood of testing positive and represents a better outcome.

Secondary

Measure	Time frame	Description
Change in Opioid Use Disorder Severity as Measured by the Rapid Opioid Dependence Screen (RODS)	From Baseline to 4 weeks (post-intervention) and from Baseline to 8 weeks (follow-up).	The Rapid Opioid Dependence Screen (RODS) is an 8-item measure used to assess opioid dependence severity. For this study, a total score was calculated by summing two components: 1) The number of endorsed opioid types from Item 1 (which lists 8 types, range 0-8), and 2) The number of yes responses to the 7 dependence-related questions in Items 2-8 (range 0-7). This method results in a total possible score range of 0 to 15. Higher scores indicate a greater breadth of lifetime opioid use and a higher number of dependence symptoms. A reduction in score represents improvement.
Change in Opioid Craving as Measured by the Opioid Craving Scale (OCS)	From Baseline to 4 weeks (post-intervention) and from Baseline to 8 weeks (follow-up).	Opioid Craving Scale (OCS) is a 3-item self-report measure used to assess opioid craving. Each of the three items is rated on a scale from 0 to 9. The total score is calculated by taking the average of the three item scores, resulting in a final score range of 0 to 9. Higher scores indicate a greater severity of craving. A reduction in score represents improvement.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Smartphone Digital Intervention Group The Smartphone Digital Intervention Group was the experimental group. Participants randomized to this group downloaded the Mood Triggers smartphone application and were asked to use it 4-6 times per week for four weeks, completing 20 digital video sessions. The app passively and continuously collected data on ambient light, GPS location, call and text logs, and screen time. The intervention, based on cognitive-behavioral therapy (CBT) principles, delivered brief informational videos (averaging \ 2 minutes) that guided participants through exercises to manage symptoms of anxiety and depression. Examples of these exercises included progressive muscle relaxation, problem-solving strategies, and relapse prevention. The app also featured optional daily prompts, adapted from the PANAS-X, to encourage self-monitoring of mood and anxiety. The videos were organized into modules addressing actions, mental hygiene, exposure, acceptance, cognitions, regulation and positive feelings, and preparation.	32
Wait List Control Condition The waitlist control group did not receive the digital intervention treatment during the eight-week study. They provided urine samples bi-weekly and were offered access to the digital intervention after completing their study participation.	31
Total	63

Baseline characteristics

Characteristic	Wait List Control Condition	Total	Smartphone Digital Intervention Group
Age, Continuous	35.47 years STANDARD_DEVIATION 9.89	37.08 years STANDARD_DEVIATION 9.62	38.74 years STANDARD_DEVIATION 9.2
Anxiety Severity as Measured by the Generalized Anxiety Disorder Questionnaire-IV (GAD-Q-IV)	10.18 units on a scale STANDARD_DEVIATION 2.2	10.15 units on a scale STANDARD_DEVIATION 2.17	10.13 units on a scale STANDARD_DEVIATION 2.17
Depression Severity as Measured by the Patient Health Questionnaire-9 (PHQ-9)	16.41 units on a scale STANDARD_DEVIATION 6.04	16.23 units on a scale STANDARD_DEVIATION 6.16	16.05 units on a scale STANDARD_DEVIATION 6.37
Opioid Craving Severity as Measured by the Opioid Craving Scale (OCS)	6.35 units on a scale STANDARD_DEVIATION 3.21	6.45 units on a scale STANDARD_DEVIATION 3.56	6.54 units on a scale STANDARD_DEVIATION 3.91
Opioid Use Disorder Severity as Measured by the Rapid Opioid Dependence Screen (RODS)	8.82 units on a scale STANDARD_DEVIATION 0.62	8.80 units on a scale STANDARD_DEVIATION 0.68	8.79 units on a scale STANDARD_DEVIATION 0.75
Race/Ethnicity, Customized Race Other/multiracial	12 Participants	16 Participants	4 Participants
Race/Ethnicity, Customized Race Prefer not to disclose	2 Participants	3 Participants	1 Participants
Race/Ethnicity, Customized Race White	17 Participants	44 Participants	27 Participants
Sex/Gender, Customized Gender Man	14 Participants	32 Participants	18 Participants
Sex/Gender, Customized Gender Prefer not to disclose	1 Participants	2 Participants	1 Participants
Sex/Gender, Customized Gender Woman	16 Participants	29 Participants	13 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 32	0 / 31
other Total, other adverse events	0 / 32	0 / 31
serious Total, serious adverse events	0 / 32	0 / 31

Outcome results

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