Substance Use Disorders
Conditions
Brief summary
The goal of this clinical trial is to evaluate the feasibility and acceptability of a digital mindfulness-based treatment for individuals in early recovery from substance use disorders. Participants are randomized to treatment-as-usual (TAU) or TAU plus the digital mindfulness-based treatment. The digital treatment will be completed over an 8-week period.
Interventions
BEHAVIORALTreatment-as-Usual (TAU)
TAU consists of weekly outpatient-based group therapy for substance use disorder
BEHAVIORALDigital Mindfulness Treatment
The digital mindfulness-based treatment is a multimedia app-based program teaching mindfulness skills to facilitate recovery from substance use disorder
Sponsors
Yale University
National Center for Complementary and Integrative Health (NCCIH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older * Fluent in English and have a 6th grade or higher reading level * Have completed 1 month or more of SUD treatment * Report use of their primary substance of choice in past 6 months * Are not currently enrolled in residential/inpatient treatment * Are willing to be randomized * Are willing and able to participate for the entire study period * Are willing to provide locator information for follow-up * Own a working, WIFI-enabled smartphone
Exclusion criteria
* Current psychotic disorder * High suicide risk characterized by suicidal ideation with intent * Homicidal ideation posing imminent danger to others * Pending legal case, imminent incarceration, or a planned move that results in inability to commit to procedures during the entire study period * Participation in the Phase 1 User Testing study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to the Digital Treatment | 8-week treatment period that begins on the day participants are randomized | Number of randomized participants completing 50% or more of the digital treatment modules. This outcome was only assessed in the digital mindfulness arm. |
| Completion Rates for the Post-treatment Assessment Visit | Approximately 9 weeks after randomization | Percentage of participants that completed post-treatment assessment visit of all randomized participants |
| Completion Rates for the 2-month Follow-up Assessment Visit | 2-month post-treatment follow-up (approximately 16 weeks post-randomization) | Percentage of participants that completed 2-month post-treatment assessment visit of all randomized participants |
| Completion Rates for Ecological Momentary Assessment at Baseline | 2-week period at baseline prior to randomization | Percentage of participants that completed 50% or more of EMA surveys at baseline of all randomized participants |
| Completion Rates for Ecological Momentary Assessment Post-treatment | Post-treatment during weeks 10 and 11 post-randomization | Percentage of participants that completed 50% or more of EMA surveys post-treatment of all randomized participants |
| Dimensions of Treatment Acceptability | Ratings made at the post-treatment assessment, which is approximately 9 weeks after randomization | Single-items measuring ratings of acceptability dimensions for the digital treatment, including willingness to engage, usability, understandability, engage-ability, visual appeal, helpfulness, skill acquisition, and confidence implementing skills. Scores for each item range from 1 to 5, with higher scores indicating better acceptability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Percent Days of Any Substance Use | Baseline, at end-of-treatment (end of week 8 post-randomization) and at the 2-month follow-up period (weeks 9 to 16 weeks post-randomization) | The Timeline Follow Back, a calendar-based interview, will be used to assess substance use. A T-statistic of 0 indicates no change; more positive scores indicate a better outcome. |
| Change in Percent Days of Primary Substance Use | Baseline through end-of-treatment (end of week 8 post-randomization) and through the 2-month follow-up period (weeks 9 to 16 weeks post-randomization) | The Timeline Follow Back, a calendar-based interview, will be used to assess substance use. A T-statistic of 0 indicates no change; more positive scores indicate a better outcome. |
| Change in Substance-related Problems | Baseline through end-of-treatment (end of week 8 post-randomization) and through the 2-month follow-up period (weeks 9 to 16 weeks post-randomization) | Short-inventory of problems Revised (SIP-R), a self-report questionnaire of substance-related problems. Total score range from 0 to 51, with higher scores indicating greater substance related problems. A T-statistic of 0 indicates no change; more positive scores indicate a better outcome. |
| Change in Brief Symptom Inventory (BSI) Score | Baseline through end-of-treatment (end of week 8 post-randomization) and through the 2-month follow-up period (weeks 9 to 16 weeks post-randomization) | BSI assesses psychiatric distress using a 5-point Likert scale, ranging from 0 ("not at all") to 4 ("extremely"). Higher scores indicate more distress. A T-statistic of 0 indicates no change; more positive scores indicate a better outcome. |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 39.53 years STANDARD_DEVIATION 9.89 |
| Education Bachelor's degree or higher | 3 Participants |
| Education High school or GED | 8 Participants |
| Education Less than high school | 3 Participants |
| Education Some college or Associate degree | 6 Participants |
| Employment status Employed | 8 Participants |
| Employment status Unemployed | 7 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Mean number of previous outpatient treatments for SUD | 3.56 treatments STANDARD_DEVIATION 1.67 |
| Mean number of previous residential treatments for SUD | 1.75 treaments STANDARD_DEVIATION 2.95 |
| Number of participants currently enrolled in Intensive Outpatient Program (IOP) for SUD | 9 Participants |
| Number of participants currently enrolled in outpatient relapse prevention groups for SUD | 17 Participants |
| Number of participants on public assistance | 11 Participants |
| Number of participants referred by criminal justice system | 13 Participants |
| Number of participants that use two or more substances | 16 Participants |
| Primary substance used Alcohol | 4 Participants |
| Primary substance used Cocaine | 8 Participants |
| Primary substance used Dissociative Drugs | 4 Participants |
| Primary substance used Hallucinogens | 0 Participants |
| Primary substance used Heroin | 1 Participants |
| Primary substance used Marijuana | 3 Participants |
| Primary substance used Opioid Pills | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) White | 13 Participants |
| Severity of Substance Use Disorder (SUD) diagnosis Mild | 4 Participants |
| Severity of Substance Use Disorder (SUD) diagnosis Moderate | 3 Participants |
| Severity of Substance Use Disorder (SUD) diagnosis Severe | 28 Participants |
| Sex/Gender, Customized Man | 9 Participants |
| Sex/Gender, Customized Transgender man | 0 Participants |
| Sex/Gender, Customized Woman | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 16 |
| other Total, other adverse events | 0 / 20 | 0 / 16 |
| serious Total, serious adverse events | 0 / 20 | 0 / 16 |
Outcome results
None listed