Substance Use Disorder (SUD)SRSSNCT02132481
Using Smartphones to Provide Recovery Support Services
A study testing EMA Only, EMI Only and EMA+EMI in people with Substance Use Disorder (SUD) and Recovery, run by Chestnut Health Systems at 3 sites in United States.
Trial summary
The primary goal of the proposed trial is to examine the effect of combining frequent self-monitoring via Ecological Momentary Assessment (EMAs) and automated interventions via Ecological Momentary Interventions (EMIs) provided by smartphone, on days of abstinence from drugs and alcohol and HIV risk behaviors over 6… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Use Disorder (SUD), Recovery
- What is being tested?
- EMA Only, EMI Only and EMA+EMI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 401 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2015to 28 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- meet criteria for SUDs in year prior to treatment intake,
- alcohol or other drug use during the 90 days prior to treatment,
- discharged to the community (vs. jail or prison) from outpatient, intensive outpatient or residential treatment,
- age 18 or older,
- communicate in English or Spanish, and
- are cognitively able to provide informed consent.
Who cannot join
- already live outside of Chicago
- plan to live outside of Chicago in the 6 months post discharge
- Expected to be in jail or prison or other setting that would prevent the use of smartphones during the 6 months post discharge
- Not able to use smartphone due to disability or health condition
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Haymarket
Chicago, Illinois, 60607
Chestnut Health Systems
Chicago, Illinois, 60610
Chestnut Health Systems
Normal, Illinois, 61761
About this study
Official title: Using Smartphones to Provide Recovery Support Services Experiment
The primary goal of the proposed trial is to examine the effect of combining frequent self-monitoring via Ecological Momentary Assessment (EMAs) and automated interventions via Ecological Momentary Interventions (EMIs) provided by smartphone, on days of abstinence from drugs and alcohol and HIV risk behaviors over 6 months following treatment discharge. We will recruit 400 participants at discharge (both planned or unplanned) from Illinois' largest treatment organization and randomly assign them in a 2 x 2 factorial design to receive EMA only, EMI only, combined EMA+EMI, or neither (control). Participants in the 3 EMA and EMI groups will receive a smartphone and training after discharge. To help them self-monitor, individuals in the EMA groups will be randomly signaled 6 times daily for 6 months and asked to record their recent substance use, HIV risk behaviors (e.g., needle use, unprotected sex) and exposure to internal and external protective and risk factors, then to rate the extent to which these factors support their recovery or make them want to use drugs or alcohol. Individuals in the EMI groups will have 24/7 access to a smartphone recovery support system. In the combined EMA+EMI group, participants will receive feedback directly following completion of each 2-3 minute EMA, and EMA responses will be used to encourage EMI utilization. The primary hypotheses are
H1 Random assignment to a) EMA (vs. not), b) EMI (vs. not), and c) their interaction will be associated with more days of abstinence from drugs and alcohol over the 6 months post discharge.
Read more
H2 Random assignment to a) EMA, b) EMI, and c) their interaction will be a associated with fewer HIV risk behaviors over the 6 months post discharge.
H3 Days abstinent at 3 months post discharge will mediate the effects of a) EMA, b) EMI and c) their interaction on HIV Risk behavior at 6 months post discharge.
Read the detailed description
Nationwide cost estimates of 60 major illnesses place alcohol use disorders as the 2nd and drug use disorders as the 7th most costly health problems. Both are related to higher rates of HIV risk behaviors associated with the human immunodeficiency virus (HIV) and together they represent 3 of the top 10 modifiable behavioral causes of mortality in the US. Studies indicate that effective strategies for managing substance use disorders (SUD) must address their chronic and cyclical nature, of which HIV risk is a part. For many, substance use creates circumstances that increase HIV risk (e.g., needle use, trading sex) and for others, substance use is a coping mechanism for the negative impact of lifestyle choices (e.g. illegal activity, losing custody of their children, trading sex). Post-discharge monitoring, feedback and early re-intervention have become standard practice when managing numerous chronic conditions.10 Mobile technology has the potential to radically improve the odds of sustained recovery by providing tools for ongoing monitoring, assessment and access to recovery support interventions anytime and anywhere. This is particularly important for the 90% of those needing treatment that don't receive it. Therefore applying smartphone technology to provide recovery management anytime anywhere is potentially significant.
Using their smartphone-based suite of relapse-prevention interventions , Gustafson and colleagues11 conducted an RCT with a sample of 350 adults with alcohol use disorders discharged from 2 residential substance abuse treatment programs and followed them for 12 months. Patients self-initiated access to the interventions 24/7; the type of interventions ranged from being professionally supported EMIs like "ask an expert" which allowed participants to receive personal responses to their questions from addiction experts to a Panic Button which triggered automated reminders to the participant and, alerts to key people (e.g., counselor, sponsor, family member) who may reach out to the participant via phone or in person. Their system was designed to support recovery by promoting autonomous motivation, coping competence, and relatedness.12 Relative to participants assigned to recovery support services as usual, those receiving the support system reported significantly fewer heavy drinking days and were more likely to be abstinent from alcohol at the end of the study.13-15 In addition, this study demonstrated that providing recovery support via smart phones is feasible for this population.
Despite these encouraging outcomes, the full potential of providing 24/7 access to recovery support via smartphones may not yet have been realized. For example, while participants rated themselves on protective and risk factors weekly, opportunities to intervene "in the moments of need" were lost if the individuals did not self-initiate use of the application, ratings were subject to recall bias, and "teachable moments" in which participants could have cognitively linked the risk factors to their desire or actual use were unexplored. More frequent monitoring of current circumstances (vs. past generalized week) using methods like Ecological Momentary Assessment (EMA) may be better suited to this context as they can improve one's level of self-monitoring, provide additional opportunities to intervene in the moment of risk, minimize recall bias and provide participants with the opportunity to learn more about the relationship between current circumstances and their use.16,17 The primary goal of the proposed trial is to examine the effect of combining more frequent self-monitoring via EMAs and automated interventions via Ecological Momentary Interventions (EMIs) provided by smartphone, on days of abstinence from drugs and alcohol and HIV risk behaviors over 6 months following treatment discharge.
We will recruit a total of 400 participants in 4 cohorts of 100 people from sequential discharges (both planned or unplanned) over 2 months starting in months 7, 19, 31, 43 and follow them for 6 months post discharge. Using urn randomization, we will randomly assign participants at discharge in a 2 x 2 factorial design to receive EMAs only, EMIs only, combined EMA+EMI or control (no EMA or EMI). Post-randomization, participants assigned to the EMA, EMI and combined EMA/EMI groups will receive a smartphone for 6 months with 450 call minutes, 500 text messages and unlimited data plan monthly. Those in the EMA only and EMA/EMI combined group will be asked at 6 randomly selected times each day (183 days total) to record their past-30-minutes involvement in HIV risk behaviors and substance use, and their exposure to internal and external risk and protective factors and rate the extent to which these factors support their recovery, make them want to use drugs and/or alcohol. Those in the EMI only and EMA/EMI combined group will have continuous access to a suite of smartphone based support services (EMIs). To minimize interference with treatment, phones will be issued and trainings will be done after discharge. To minimize potential contamination across conditions, trainings for each condition will occur on separate days. During the month following treatment discharge \& training, participants in the three experimental groups will return to the research office 2 times a week for research staff to check participant's proficiency operating the phone and collect urine screens. To control for the effects of attention, the control group will also return to the research office 2 times a week for urine screens and a short survey on non-phone related topics. Research office visits and trainings will be done by Protocol Monitors (not interviewers). Research Interviewers blind to condition will conduct the discharge, 3 and 6 months post discharge interviews and urine tests. EMA and EMI utilization data will be electronically recorded immediately via a mobile/web application and used to track implementation.
The primary hypotheses are
H1 Random assignment to a) EMA (vs. not), b) EMI (vs. not), and c) their interaction will be associated with more days of abstinence from drugs and alcohol over the 6 months post discharge.
H2 Random assignment to a) EMA, b) EMI, and c) their interaction will be a associated with fewer HIV risk behaviors over the 6 months post discharge.
H3 Days abstinent at 3 months post discharge will mediate the effects of a) EMA, b) EMI and c) their interaction on HIV Risk behavior at 6 months post discharge.
- Conditions
- Substance Use Disorder (SUD), Recovery
- Being tested
- EMA Only, EMI Only, EMA+EMI, Neither - RSAU
- Keywords
- Smartphones, Mobile phones, Substance use disorder, Recovery Support Services, Ecological Momentary Assessment (EMA), Ecological Momentary Intervention (EMI), Randomized field experiment, Effectiveness, Post-Discharge
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMA OnlyOther
Also called Ecological Momentary Assessment (EMA)
The EMA only condition consists of: a) RSAU, b) an Android phone, c) a 6-hour EMA training on how to use the phone, HIV and SUD prevention, self-monitoring, procedures for completing the EMAs (see Appendix), d) an EMA signaling schedule covering 6 EMA prompts over a 16-hour time period per day tailored to each participant's schedule, e) research office visits twice a week during 1st month for staff to check participant's proficiency using the phone and completing EMAs, and f) collecting urine screens.
EMI OnlyOther
Also called Ecological Momentary Intervention (EMI)
The EMI only condition includes: a) RSAU, b) an Android phone, c) a 6-hour EMI training on how to use the phone, HIV and SUD prevention, how each EMI relates to relapse prevention or HIV risk reduction, and how to access each EMI, d) research office visits twice weekly in 1st month as described above except visits focus on EMIs, and e) collecting urine screens.
EMA+EMIOther
Also called Combined Ecological Momentary Assessment (EMA), and Ecological Momentary Interventions (EMI)
The combined condition includes: a) RSAU, b) an Android phone, c) the 6-hour EMA training, d) EMA signaling schedule, e) the 6-hour EMI training, f) research office visits 2 times a week during 1st month, and g) feedback following each EMA, which will include participants' current "risk of use in the next 7 days" .
Neither - RSAUOther
Also called Recovery support as usual (RSAU)
The "neither" smartphone condition will still have access to community recovery support as usual (RSAU). Standard discharge practice is to provide a recovery plan and relevant referrals. A recent RCT indicated that after leaving treatment, 37% of the clients attended self-help in the community, 41% participated in substance-free structured activities, and about 14% returned to treatment within 6 months. They will also participate in office visits twice a week during 1st month to complete non-phone related surveys and provide urine for screens.
| Study group | Role | What they receive |
|---|---|---|
| EMA Only | Experimental | See intervention Receives: Other: EMA Only; Other: Neither - RSAU |
| EMI Only | Experimental | See intervention Receives: Other: EMI Only; Other: Neither - RSAU |
| EMA+EMI | Experimental | See intervention Receives: Other: EMA Only; Other: EMI Only; Other: EMA+EMI; Other: Neither - RSAU |
| Neither - RSAU | Active comparator | See intervention Receives: Other: Neither - RSAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days of Abstinence
Days of Abstinence (test-retest rho=.96)= Self-reported days of no drug or alcohol use summed across follow-up waves. An alternative measure is also available, the Substance Frequency Scale (SFS; alpha=.85; test-retest rho=.94), which is the average percent of days reported of any substance use, days of heavy substance use, days of problems from substance use, and days of alcohol, marijuana, crack/cocaine and heroin use. Will be over all 6 months for H1, over the first 3 months for H3.
Measured: 3 and 6 months post discharge
Secondary outcomes (2)
EMA & EMI utilization
EMA \& EMI utilization: Computer logs of the EMA responses and EMI utilization (including time/date stamps) will be used to document implementation.
Measured: Continuous over 6 months post discharge
HIV Risk Behavior Index
HIV Risk Behavior Index (test-retest rho=.80)= A count of HIV risk behaviors in the past 90 days (any needle use, needle sharing, unprotected sex, multiple sexual partners, trading sex, victimization). Will be over all 6 months for H2, over the last 3 months for H3
Measured: Months 4-6 post discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2014 (estimated)
- Study startJun 2015
- Primary completion31 Jan 2018
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance Use Disorder (SUD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 401 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chestnut Health Systems
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Christy Scott, Chestnut Health Systems
- Investigators
- Christy K Scott, Ph.D., Principal investigator, Chestnut Health SystemsWilliam L White, M.A., Study chair, Chestnut Health Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02132481
- Sponsor's protocol ID
- SRSS Experiment
- Other IDs
- R01DA035879
- Acronym
- SRSS
- Status last verified
- Jul 2021
- First submitted
- 5 May 2014
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: After the study is completed, interested researchers can contact the study PI for permission to use the individual level (but de-identified) data.
Publications
Scott CK, Dennis ML, Gustafson DH. Using smartphones to decrease substance use via self-monitoring and recovery support: study protocol for a randomized control trial. Trials. 2017 Aug 10;18(1):374. doi: 10.1186/s13063-017-2096-z.
PubMed 28797307
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Smartphones to Provide Recovery Support Services Experiment
- ClinicalTrials.gov ID
- NCT02132481
- Acronym / sponsor ID
- SRSS / SRSS Experiment
- Conditions
- Substance Use Disorder (SUD), Recovery
- Keywords
- Smartphones, Mobile phones, Substance use disorder, Recovery Support Services, Ecological Momentary Assessment (EMA), Ecological Momentary Intervention (EMI), Randomized field experiment, Effectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 401 participants (actual)
- Lead sponsor
- Chestnut Health SystemsUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jun 2015
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 7 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary goal of the proposed trial is to examine the effect of combining frequent self-monitoring via Ecological Momentary Assessment (EMAs) and automated interventions via Ecological Momentary Interventions (EMIs) provided by smartphone, on days of abstinence from drugs and alcohol and HIV risk behaviors over 6 months following treatment discharge. We will recruit 400 participants at discharge (both planned or unplanned) from Illinois' largest treatment organization and randomly assign them in a 2 x 2 factorial design to receive EMA only, EMI only, combined EMA+EMI, or neither (control). Participants in the 3 EMA and EMI groups will receive a smartphone and training after discharge. To help them self-monitor, individuals in the EMA groups will be randomly signaled 6 times daily for 6 months and asked to record their recent substance use, HIV risk behaviors (e.g., needle use, unprotected sex) and exposure to internal and external protective and risk factors, then to rate the extent to which these factors support their recovery or make them want to use drugs or alcohol. Individuals in the EMI groups will have 24/7 access to a smartphone recovery support system. In the combined EMA+EMI group, participants will receive feedback directly following completion of each 2-3 minute EMA, and EMA responses will be used to encourage EMI utilization. The primary hypotheses are
H1 Random assignment to a) EMA (vs. not), b) EMI (vs. not), and c) their interaction will be associated with more days of abstinence from drugs and alcohol over the 6 months post discharge.
H2 Random assignment to a) EMA, b) EMI, and c) their interaction will be a associated with fewer HIV risk behaviors over the 6 months post discharge.
H3 Days abstinent at 3 months post discharge will mediate the effects of a) EMA, b) EMI and c) their interaction on HIV Risk behavior at 6 months post discharge.
Detailed description
Nationwide cost estimates of 60 major illnesses place alcohol use disorders as the 2nd and drug use disorders as the 7th most costly health problems. Both are related to higher rates of HIV risk behaviors associated with the human immunodeficiency virus (HIV) and together they represent 3 of the top 10 modifiable behavioral causes of mortality in the US. Studies indicate that effective strategies for managing substance use disorders (SUD) must address their chronic and cyclical nature, of which HIV risk is a part. For many, substance use creates circumstances that increase HIV risk (e.g., needle use, trading sex) and for others, substance use is a coping mechanism for the negative impact of lifestyle choices (e.g. illegal activity, losing custody of their children, trading sex). Post-discharge monitoring, feedback and early re-intervention have become standard practice when managing numerous chronic conditions.10 Mobile technology has the potential to radically improve the odds of sustained recovery by providing tools for ongoing monitoring, assessment and access to recovery support interventions anytime and anywhere. This is particularly important for the 90% of those needing treatment that don't receive it. Therefore applying smartphone technology to provide recovery management anytime anywhere is potentially significant.
Using their smartphone-based suite of relapse-prevention interventions , Gustafson and colleagues11 conducted an RCT with a sample of 350 adults with alcohol use disorders discharged from 2 residential substance abuse treatment programs and followed them for 12 months. Patients self-initiated access to the interventions 24/7; the type of interventions ranged from being professionally supported EMIs like "ask an expert" which allowed participants to receive personal responses to their questions from addiction experts to a Panic Button which triggered automated reminders to the participant and, alerts to key people (e.g., counselor, sponsor, family member) who may reach out to the participant via phone or in person. Their system was designed to support recovery by promoting autonomous motivation, coping competence, and relatedness.12 Relative to participants assigned to recovery support services as usual, those receiving the support system reported significantly fewer heavy drinking days and were more likely to be abstinent from alcohol at the end of the study.13-15 In addition, this study demonstrated that providing recovery support via smart phones is feasible for this population.
Despite these encouraging outcomes, the full potential of providing 24/7 access to recovery support via smartphones may not yet have been realized. For example, while participants rated themselves on protective and risk factors weekly, opportunities to intervene "in the moments of need" were lost if the individuals did not self-initiate use of the application, ratings were subject to recall bias, and "teachable moments" in which participants could have cognitively linked the risk factors to their desire or actual use were unexplored. More frequent monitoring of current circumstances (vs. past generalized week) using methods like Ecological Momentary Assessment (EMA) may be better suited to this context as they can improve one's level of self-monitoring, provide additional opportunities to intervene in the moment of risk, minimize recall bias and provide participants with the opportunity to learn more about the relationship between current circumstances and their use.16,17 The primary goal of the proposed trial is to examine the effect of combining more frequent self-monitoring via EMAs and automated interventions via Ecological Momentary Interventions (EMIs) provided by smartphone, on days of abstinence from drugs and alcohol and HIV risk behaviors over 6 months following treatment discharge.
We will recruit a total of 400 participants in 4 cohorts of 100 people from sequential discharges (both planned or unplanned) over 2 months starting in months 7, 19, 31, 43 and follow them for 6 months post discharge. Using urn randomization, we will randomly assign participants at discharge in a 2 x 2 factorial design to receive EMAs only, EMIs only, combined EMA+EMI or control (no EMA or EMI). Post-randomization, participants assigned to the EMA, EMI and combined EMA/EMI groups will receive a smartphone for 6 months with 450 call minutes, 500 text messages and unlimited data plan monthly. Those in the EMA only and EMA/EMI combined group will be asked at 6 randomly selected times each day (183 days total) to record their past-30-minutes involvement in HIV risk behaviors and substance use, and their exposure to internal and external risk and protective factors and rate the extent to which these factors support their recovery, make them want to use drugs and/or alcohol. Those in the EMI only and EMA/EMI combined group will have continuous access to a suite of smartphone based support services (EMIs). To minimize interference with treatment, phones will be issued and trainings will be done after discharge. To minimize potential contamination across conditions, trainings for each condition will occur on separate days. During the month following treatment discharge \& training, participants in the three experimental groups will return to the research office 2 times a week for research staff to check participant's proficiency operating the phone and collect urine screens. To control for the effects of attention, the control group will also return to the research office 2 times a week for urine screens and a short survey on non-phone related topics. Research office visits and trainings will be done by Protocol Monitors (not interviewers). Research Interviewers blind to condition will conduct the discharge, 3 and 6 months post discharge interviews and urine tests. EMA and EMI utilization data will be electronically recorded immediately via a mobile/web application and used to track implementation.
The primary hypotheses are
H1 Random assignment to a) EMA (vs. not), b) EMI (vs. not), and c) their interaction will be associated with more days of abstinence from drugs and alcohol over the 6 months post discharge.
H2 Random assignment to a) EMA, b) EMI, and c) their interaction will be a associated with fewer HIV risk behaviors over the 6 months post discharge.
H3 Days abstinent at 3 months post discharge will mediate the effects of a) EMA, b) EMI and c) their interaction on HIV Risk behavior at 6 months post discharge.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| EMA Only | Experimental | Other: EMA Only, Other: Neither - RSAUSee intervention |
| EMI Only | Experimental | Other: EMI Only, Other: Neither - RSAUSee intervention |
| EMA+EMI | Experimental | Other: EMA Only, Other: EMI Only, Other: EMA+EMI, Other: Neither - RSAUSee intervention |
| Neither - RSAU | Active comparator | Other: Neither - RSAUSee intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- meet criteria for SUDs in year prior to treatment intake,
- alcohol or other drug use during the 90 days prior to treatment,
- discharged to the community (vs. jail or prison) from outpatient, intensive outpatient or residential treatment,
- age 18 or older,
- communicate in English or Spanish, and
Key exclusion criteria (4 listed)
- already live outside of Chicago
- plan to live outside of Chicago in the 6 months post discharge
- Expected to be in jail or prison or other setting that would prevent the use of smartphones during the 6 months post discharge
- Not able to use smartphone due to disability or health condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMA OnlyAlso: Ecological Momentary Assessment (EMA)The EMA only condition consists of: a) RSAU, b) an Android phone, c) a 6-hour EMA training on how to use the phone, HIV and SUD prevention, self-monitoring, procedures for completing the EMAs (see Appendix), d) an EMA signaling schedule covering 6 EMA prompts over a 16-hour time period per day tailored to each participant's schedule, e) research office visits twice a week during 1st month for staff to check participant's proficiency using the phone and completing EMAs, and f) collecting urine screens. | Other | EMA Only, EMA+EMI |
| EMI OnlyAlso: Ecological Momentary Intervention (EMI)The EMI only condition includes: a) RSAU, b) an Android phone, c) a 6-hour EMI training on how to use the phone, HIV and SUD prevention, how each EMI relates to relapse prevention or HIV risk reduction, and how to access each EMI, d) research office visits twice weekly in 1st month as described above except visits focus on EMIs, and e) collecting urine screens. | Other | EMA+EMI, EMI Only |
| EMA+EMIAlso: Combined Ecological Momentary Assessment (EMA), and Ecological Momentary Interventions (EMI)The combined condition includes: a) RSAU, b) an Android phone, c) the 6-hour EMA training, d) EMA signaling schedule, e) the 6-hour EMI training, f) research office visits 2 times a week during 1st month, and g) feedback following each EMA, which will include participants' current "risk of use in the next 7 days" . | Other | EMA+EMI |
| Neither - RSAUAlso: Recovery support as usual (RSAU)The "neither" smartphone condition will still have access to community recovery support as usual (RSAU). Standard discharge practice is to provide a recovery plan and relevant referrals. A recent RCT indicated that after leaving treatment, 37% of the clients attended self-help in the community, 41% participated in substance-free structured activities, and about 14% returned to treatment within 6 months. They will also participate in office visits twice a week during 1st month to complete non-phone related surveys and provide urine for screens. | Other | EMA Only, EMA+EMI, EMI Only, Neither - RSAU |
Primary outcome
Days of Abstinence
Time frame: 3 and 6 months post discharge
Days of Abstinence (test-retest rho=.96)= Self-reported days of no drug or alcohol use summed across follow-up waves. An alternative measure is also available, the Substance Frequency Scale (SFS; alpha=.85; test-retest rho=.94), which is the average percent of days reported of any substance use, days of heavy substance use, days of problems from substance use, and days of alcohol, marijuana, crack/cocaine and heroin use. Will be over all 6 months for H1, over the first 3 months for H3.
2 secondary outcomes
EMA & EMI utilization
Time frame: Continuous over 6 months post discharge
HIV Risk Behavior Index
Time frame: Months 4-6 post discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- Derived from this study: PubMed 28797307Scott CK, Dennis ML, Gustafson DH. Using smartphones to decrease substance use via self-monitoring and recovery support: study protocol for a randomized control trial. Trials. 2017 Aug 10;18(1):374. doi: 10.1186/s13063-017-2096-z.
- Chestnut Health SystemsLink provided by the sponsor.
- Haymarket CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. After the study is completed, interested researchers can contact the study PI for permission to use the individual level (but de-identified) data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christy K Scott, Ph.D. principal investigator
Chestnut Health Systems
William L White, M.A. study chair
Chestnut Health Systems
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMA Only, EMI Only and EMA+EMI in people with Substance Use Disorder (SUD) and Recovery, run by Chestnut Health Systems at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days of Abstinence (time frame: 3 and 6 months post discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02132481, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2021.