NCT02132481

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
401

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 7, 2014

Completed
1.1 years until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2018

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2021

Completed
Last Updated

July 28, 2021

Status Verified

July 1, 2021

Enrollment Period

2.7 years

First QC Date

May 5, 2014

Last Update Submit

July 27, 2021

Conditions

Keywords

SmartphonesMobile phonesSubstance use disorderRecovery Support ServicesEcological Momentary Assessment (EMA)Ecological Momentary Intervention (EMI)Randomized field experimentEffectivenessPost-Discharge

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

EXPERIMENTAL

See intervention

Other: EMA OnlyOther: Neither - RSAU

EMI Only

EXPERIMENTAL

See intervention

Other: EMI OnlyOther: Neither - RSAU

EMA+EMI

EXPERIMENTAL

See intervention

Other: EMA OnlyOther: EMI OnlyOther: EMA+EMIOther: Neither - RSAU

Neither - RSAU

ACTIVE COMPARATOR

See intervention

Other: Neither - RSAU

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.

Also known as: Ecological Momentary Assessment (EMA)
EMA OnlyEMA+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.

Also known as: Ecological Momentary Intervention (EMI)
EMA+EMIEMI Only
EMA+EMIOTHER

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" .

Also known as: Combined Ecological Momentary Assessment (EMA), and Ecological Momentary Interventions (EMI)
EMA+EMI

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.

Also known as: Recovery support as usual (RSAU)
EMA OnlyEMA+EMIEMI OnlyNeither - RSAU

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (3)

Haymarket

Chicago, Illinois, 60607, United States

Location

Chestnut Health Systems

Chicago, Illinois, 60610, United States

Location

Chestnut Health Systems

Normal, Illinois, 61761, United States

Location

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.

Related Links

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Ecological Momentary Assessment

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and Activities

Study Officials

  • Christy K Scott, Ph.D.

    Chestnut Health Systems

    PRINCIPAL INVESTIGATOR
  • William L White, M.A.

    Chestnut Health Systems

    STUDY CHAIR

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.

Locations