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Using Smartphones to Provide Recovery Support Services (SRSS)

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ClinicalTrials.gov Identifier: NCT02132481
Recruitment Status : Active, not recruiting
First Posted : May 7, 2014
Last Update Posted : January 22, 2020
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Christy Scott, Chestnut Health Systems

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.


Condition or disease Intervention/treatment Phase
Substance Use Disorder (SUD) Recovery Other: EMA Only Other: EMI Only Other: EMA+EMI Other: Neither - RSAU Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 401 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Using Smartphones to Provide Recovery Support Services Experiment
Study Start Date : June 2015
Actual Primary Completion Date : October 2018
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: EMA Only
See intervention
Other: EMA Only
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 Name: Ecological Momentary Assessment (EMA)

Other: Neither - 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 Name: Recovery support as usual (RSAU)

Experimental: EMI Only
See intervention
Other: EMI Only
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 Name: Ecological Momentary Intervention (EMI)

Other: Neither - 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 Name: Recovery support as usual (RSAU)

Experimental: EMA+EMI
See intervention
Other: EMA Only
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 Name: Ecological Momentary Assessment (EMA)

Other: EMI Only
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 Name: Ecological Momentary Intervention (EMI)

Other: EMA+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 Names:
  • Combined Ecological Momentary Assessment (EMA)
  • and Ecological Momentary Interventions (EMI)

Other: Neither - 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 Name: Recovery support as usual (RSAU)

Active Comparator: Neither - RSAU
See intervention
Other: Neither - 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 Name: Recovery support as usual (RSAU)




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. EMA & EMI utilization [ Time Frame: Continuous over 6 months post discharge ]
    EMA & EMI utilization: Computer logs of the EMA responses and EMI utilization (including time/date stamps) will be used to document implementation.

  2. HIV Risk Behavior Index [ Time Frame: Months 4-6 post discharge ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02132481


Locations
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United States, Illinois
Haymarket
Chicago, Illinois, United States, 60607
Chestnut Health Systems
Chicago, Illinois, United States, 60610
Chestnut Health Systems
Normal, Illinois, United States, 61761
Sponsors and Collaborators
Chestnut Health Systems
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Christy K Scott, Ph.D. Chestnut Health Systems
Study Chair: William L White, M.A. Chestnut Health Systems
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Christy Scott, Director of Research and Development, Chestnut Health Systems
ClinicalTrials.gov Identifier: NCT02132481    
Other Study ID Numbers: SRSS Experiment
R01DA035879 ( U.S. NIH Grant/Contract )
First Posted: May 7, 2014    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Keywords provided by Christy Scott, Chestnut Health Systems:
Smartphones
Mobile phones
Substance use disorder
Recovery Support Services
Ecological Momentary Assessment (EMA)
Ecological Momentary Intervention (EMI)
Randomized field experiment
Effectiveness
Post-Discharge
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders