Using Smartphones to Provide Recovery Support Services
SRSS
2 other identifiers
interventional
401
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2015
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 5, 2014
CompletedFirst Posted
Study publicly available on registry
May 7, 2014
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2021
CompletedJuly 28, 2021
July 1, 2021
2.7 years
May 5, 2014
July 27, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
3 and 6 months post discharge
Secondary Outcomes (2)
EMA & EMI utilization
Continuous over 6 months post discharge
HIV Risk Behavior Index
Months 4-6 post discharge
Study Arms (4)
EMA Only
EXPERIMENTALSee intervention
EMI Only
EXPERIMENTALSee intervention
EMA+EMI
EXPERIMENTALSee intervention
Neither - RSAU
ACTIVE COMPARATORSee intervention
Interventions
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.
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.
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" .
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chestnut Health Systemslead
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (3)
Haymarket
Chicago, Illinois, 60607, United States
Chestnut Health Systems
Chicago, Illinois, 60610, United States
Chestnut Health Systems
Normal, Illinois, 61761, United States
Related Publications (1)
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.
PMID: 28797307DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christy K Scott, Ph.D.
Chestnut Health Systems
- STUDY CHAIR
William L White, M.A.
Chestnut Health Systems
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Research and Development
Study Record Dates
First Submitted
May 5, 2014
First Posted
May 7, 2014
Study Start
June 1, 2015
Primary Completion
January 31, 2018
Study Completion
February 28, 2021
Last Updated
July 28, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will share
After the study is completed, interested researchers can contact the study PI for permission to use the individual level (but de-identified) data.