search
Back to results

Using Smartphones to Provide Recovery Support Services (SRSS)

Primary Purpose

Substance Use Disorder (SUD), Recovery

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EMA Only
EMI Only
EMA+EMI
Neither - RSAU
Sponsored by
Chestnut Health Systems
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Substance Use Disorder (SUD) focused on measuring Smartphones, Mobile phones, Substance use disorder, Recovery Support Services, Ecological Momentary Assessment (EMA), Ecological Momentary Intervention (EMI), Randomized field experiment, Effectiveness, Post-Discharge

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. meet criteria for SUDs in year prior to treatment intake,
  2. alcohol or other drug use during the 90 days prior to treatment,
  3. discharged to the community (vs. jail or prison) from outpatient, intensive outpatient or residential treatment,
  4. age 18 or older,
  5. communicate in English or Spanish, and
  6. are cognitively able to provide informed consent.

    Exclusion Criteria:

  7. already live outside of Chicago
  8. plan to live outside of Chicago in the 6 months post discharge
  9. Expected to be in jail or prison or other setting that would prevent the use of smartphones during the 6 months post discharge
  10. Not able to use smartphone due to disability or health condition

Sites / Locations

  • Haymarket
  • Chestnut Health Systems
  • Chestnut Health Systems

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

EMA Only

EMI Only

EMA+EMI

Neither - RSAU

Arm Description

See intervention

See intervention

See intervention

See intervention

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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

Full Information

First Posted
May 5, 2014
Last Updated
July 27, 2021
Sponsor
Chestnut Health Systems
Collaborators
National Institute on Drug Abuse (NIDA)
search

1. Study Identification

Unique Protocol Identification Number
NCT02132481
Brief Title
Using Smartphones to Provide Recovery Support Services
Acronym
SRSS
Official Title
Using Smartphones to Provide Recovery Support Services Experiment
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
January 31, 2018 (Actual)
Study Completion Date
February 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chestnut Health Systems
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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, Post-Discharge

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
401 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EMA Only
Arm Type
Experimental
Arm Description
See intervention
Arm Title
EMI Only
Arm Type
Experimental
Arm Description
See intervention
Arm Title
EMA+EMI
Arm Type
Experimental
Arm Description
See intervention
Arm Title
Neither - RSAU
Arm Type
Active Comparator
Arm Description
See intervention
Intervention Type
Other
Intervention Name(s)
EMA Only
Other Intervention Name(s)
Ecological Momentary Assessment (EMA)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
EMI Only
Other Intervention Name(s)
Ecological Momentary Intervention (EMI)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
EMA+EMI
Other Intervention Name(s)
Combined Ecological Momentary Assessment (EMA), and Ecological Momentary Interventions (EMI)
Intervention Description
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" .
Intervention Type
Other
Intervention Name(s)
Neither - RSAU
Other Intervention Name(s)
Recovery support as usual (RSAU)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Days of Abstinence
Description
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.
Time Frame
3 and 6 months post discharge
Secondary Outcome Measure Information:
Title
EMA & EMI utilization
Description
EMA & EMI utilization: Computer logs of the EMA responses and EMI utilization (including time/date stamps) will be used to document implementation.
Time Frame
Continuous over 6 months post discharge
Title
HIV Risk Behavior Index
Description
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
Time Frame
Months 4-6 post discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christy K Scott, Ph.D.
Organizational Affiliation
Chestnut Health Systems
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
William L White, M.A.
Organizational Affiliation
Chestnut Health Systems
Official's Role
Study Chair
Facility Information:
Facility Name
Haymarket
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Facility Name
Chestnut Health Systems
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60610
Country
United States
Facility Name
Chestnut Health Systems
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
After the study is completed, interested researchers can contact the study PI for permission to use the individual level (but de-identified) data.
Citations:
PubMed Identifier
28797307
Citation
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.
Results Reference
derived
Links:
URL
http://www.chestnut.org/li
Description
Chestnut Health Systems
URL
http://www.hcenter.org
Description
Haymarket Center

Learn more about this trial

Using Smartphones to Provide Recovery Support Services

We'll reach out to this number within 24 hrs