Substance Use DisordersNCT04098614
Barriers to Substance Use Disorder Recovery
A study testing Recovery Coach Intervention in people with Substance Use Disorders, run by Prisma Health-Upstate at 1 site in United States.
Trial summary
The study purpose is to investigate how an inpatient recovery coaching intervention can overcome or mitigate specific risk factors and barriers to initiating and maintaining Substance Use Disorder recovery. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Substance Use Disorders
- What is being tested?
- Recovery Coach Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2019to 18 Dec 2020
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 - 60
- English speaking;
- Identified by healthcare provider as having Substance Use Disorder
- Recent substance use
- Currently admitted to the Medical Teaching Services, general medicine hospitalist services, or Infectious Disease Consult service at Greenville Memorial Hospital
Who cannot join
- Are unable to provide informed consent (intubation, confusion, etc.) during hospitalization
- Are admitted for marijuana use only
- Are admitted for cocaine use only
- Are pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Greenville Memorial Hospital
Greenville, South Carolina, 29605
About this study
The study purpose is to investigate how an inpatient recovery coaching intervention can overcome or mitigate specific risk factors and barriers to initiating and maintaining Substance Use Disorder recovery. This study will offer insight into how and why an inpatient link to recovery coaching is effective for promoting long-term Substance Use Disorder recovery.
Read the detailed description
Substance Use Disorder (SUD) is a prevalent disease that impacts an estimated 24 million Americans each year. The life-altering consequences of SUD are both diverse and severe, influencing mortality, the workplace, and economics. The goal of this study is to determine how specific risk factors of relapse and barriers to recovery, including neurocognitive, health, personal, social, financial, and situational barriers, can be overcome or changed through a recovery coaching intervention. This work seeks to provide a mechanism to demonstrate exactly how and why this potential new model of care (recovery coaching) is effective, rather than simply assessing if it can work. To accomplish this aim, the change between baseline and 6-month assessments will be assessed. Then, the difference in the change between individuals assigned to the current standard of care and patients assigned to inpatient recovery will be compared.
- Conditions
- Substance Use Disorders
- Being tested
- Recovery Coach Intervention
- Keywords
- recovery coaching, risk factors, substance abuse, EEG
- 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.
Recovery Coach InterventionBehavioural
Participants randomized to the intervention arm are linked to a recovery peer coach while they are in the hospital. Recovery peer coaches are provided to the participant by Faces and Voices of Recovery (FAVOR) - Greenville. Recovery coaches are Certified Peer Support Specialists (CPSS), individuals who have firsthand experience in successful recovery and are trained in using recovery-oriented tools to help peers overcome addiction. FAVOR offers immediate access to a personal coach, a local center, and assistance to off-site intervention and recovery resources in the community. They provide twice weekly contact with participants.
| Study group | Role | What they receive |
|---|---|---|
| Recovery Coach Intervention | Experimental | Experimental: Recovery Coach Intervention Participants randomized to the intervention arm are linked to a recovery peer coach while they are in the hospital. Recovery peer coaches are provided to the participant by Faces and Voices of Recovery (FAVOR)
- Greenville. Recovery coaches are Certified Peer Support Specialists (CPSS), individuals who have firsthand experience in successful recovery and are trained in using recovery-oriented tools to help peers overcome addiction. FAVOR offers immediate access to a personal coach, a local center, and assistance to off-site intervention and recovery resources in the community. They provide twice weekly contact with participants. Receives: Behavioral: Recovery Coach Intervention |
| Standard of Care Control | No intervention | Patients in the control condition receive the current standard of care, which entails a treatment referral with a list of addiction recovery facilities, groups, and resources. It is the patient's responsibility to call a treatment facility or group on the list and thus relies on self-referral. The medical team is not permitted to call a facility or group on behalf of the patient. The physician may counsel the patient on the dangers of substance abuse and addiction, but the extent of counseling is variable and dependent on the individual physician. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Social Support
Participants will complete the 5-item Social Support subscale of the Assessment of Recovery Capital (ARC) to assess social support. The difference between the post-baseline and baseline measures will be assessed.
Measured: intervals of 1, 2, 3, and 6 months post-baseline assessment
Change in Financial Barriers to SUD Recovery
These barriers include lack of stable housing, transportation, and cost of recovery services. Participants will complete the Housing and Safety Subscale of the Assessment of Recovery Capital (ARC) to assess social support and housing stability. The difference between the post-baseline and baseline measures will be assessed.
Measured: intervals of 1, 2, 3, and 6 months post-baseline assessment
Change in Situational Barriers to SUD Recovery
The barriers measured will be (1) long delays for treatment, (2) complexity of navigating the healthcare system, (3) lack of programs in one's community, (4)lack of professional help, (4) and not knowing where to go for help. The response options are binary (yes, they think this is a barrier to their recovery', or 'no, not a barrier to recovery'). Responses to these questions (0=no, 1=yes) will be summed to determine situational barriers. The difference between the post-baseline and baseline measures will be assessed.
Measured: intervals of 1, 2, 3, and 6 months post-baseline assessment
Change in Inhibitory Control
Inhibitory control will be assessed behaviorally using a 150 - 200 trial computerized 'Stop Signal' Task, the most common measure of this construct. Stop Signal Reaction Time (SSRT) and Stop trial accuracy will be measured and compared across time points.
Measured: baseline and 6 months post-baseline assessment
Change in Resting State EEG beta poewer
We will measure both absolute and relative powers for beta (14-25 Hz) bands using a 24-channel Soterix Medical EEG.
Measured: baseline and 6 months post-baseline assessment
Change in Striatal Dopaminergic Functioning
Consistent with previous research, we will assess average spontaneous eyeblink rate, a well-validated indirect proxy for available levels of striatal tonic dopamine.
Measured: baseline and 6 months post-baseline assessment
Change in Risk-Taking
Risk-taking will be measured using the 7-item Risk Propensity Scale (Meertens \& Lion, 2008). Higher scores on this scale indicate greater risk-taking propensity.
Measured: baseline and 6 months post-baseline assessment
Change in Emotion Regulation
The Emotion Regulation Questionnaire (ERQ-10) will be used to assess these emotion regulation strategies and skills.
Measured: baseline and 6 months post-baseline assessment
Change in Goal-Related Activities
Participants will complete the 5-item Meaningful Activities from the Assessment of Recovery Capital questionnaire. The 5 items will be summed for a total score.
Measured: baseline and 6 months post-baseline assessment
Secondary outcomes (5)
Engagement in Recovery Services
Active involvement in recovery programs. This is a binary response question. Participants are asked "Are you actively involved in a recovery program right now?". Response options are 'yes' or 'no'. We will measure the change over time in engagement for each participant and compare the percentage of those in the intervention and control arm that are actively involved in recovery services at each time point.
Measured: intervals of 1, 2, 3, and 6 months post-baseline assessment
Hospital Visit Frequency
number of readmissions and number of emergency department visits
Measured: six months pre- and post-baseline assessment
Substance Use Severity
Frequency of substance use in past 30 days measured using the Addiction Severity Index (ASI-Lite).
Measured: intervals of 1, 2, 3, and 6 months post-baseline assessment
Emotional Well-being
Participants will be asked to self-report two items about their emotion well-being on a scale of 0 (Not at all) to 9 (Severely). The questions are "In the past 30 days, how much have you been bothered by feeling sad, down, or uninterested in life?" and "In the past 30-days, have you felt anxious or nervous?".
Measured: intervals of 1, 2, 3, and 6 months post-baseline assessment
Life Satisfaction
Participants will be asked to self-report their life satisfaction using a single item question on a scale of 1 (Very Satisfied) to 4 (Very Dissatisfied). Change across time on this scale will be measured.
Measured: intervals of 1, 2, 3, and 6 months post-baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start3 Sep 2019
- Primary completion18 Dec 2020
- Study completion18 Dec 2020
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 DisordersStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The investigator/study personnel inform the participant regarding which arm they have been assigned and inform a recovery coach if the participant is randomized to the intervention arm.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prisma Health-Upstate
- Sponsor type
- University, hospital or other
- Collaborators
- Clemson University, Medical University of South Carolina
- Responsible party
- Principal investigator, Prerana Roth, Prisma Health-Upstate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04098614
- Sponsor's protocol ID
- Pro00087080
- Status last verified
- Feb 2021
- First submitted
- 11 Jun 2019
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cupp JA, Byrne KA, Herbert K, Roth PJ. Acute Care Utilization After Recovery Coaching Linkage During Substance-Related Inpatient Admission: Results of Two Randomized Controlled Trials. J Gen Intern Med. 2022 Aug;37(11):2768-2776. doi: 10.1007/s11606-021-07360-w. Epub 2022 Mar 16.
PubMed 35296984
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Barriers to Substance Use Disorder Recovery
- ClinicalTrials.gov ID
- NCT04098614
- Acronym / sponsor ID
- Pro00087080
- Conditions
- Substance Use Disorders
- Keywords
- recovery coaching, risk factors, substance abuse, EEG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Prisma Health-UpstateUniversity, hospital or other
- Collaborators
- Clemson University, Medical University of South Carolina
- Study start
- 3 Sep 2019 (actual)
- Primary completion
- 18 Dec 2020 (actual)
- Study completion
- 18 Dec 2020 (actual)
- First posted
- 23 Sep 2019 (actual)
- 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 study purpose is to investigate how an inpatient recovery coaching intervention can overcome or mitigate specific risk factors and barriers to initiating and maintaining Substance Use Disorder recovery. This study will offer insight into how and why an inpatient link to recovery coaching is effective for promoting long-term Substance Use Disorder recovery.
Detailed description
Substance Use Disorder (SUD) is a prevalent disease that impacts an estimated 24 million Americans each year. The life-altering consequences of SUD are both diverse and severe, influencing mortality, the workplace, and economics. The goal of this study is to determine how specific risk factors of relapse and barriers to recovery, including neurocognitive, health, personal, social, financial, and situational barriers, can be overcome or changed through a recovery coaching intervention. This work seeks to provide a mechanism to demonstrate exactly how and why this potential new model of care (recovery coaching) is effective, rather than simply assessing if it can work. To accomplish this aim, the change between baseline and 6-month assessments will be assessed. Then, the difference in the change between individuals assigned to the current standard of care and patients assigned to inpatient recovery will be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The investigator/study personnel inform the participant regarding which arm they have been assigned and inform a recovery coach if the participant is randomized to the intervention arm.
| Arm | Type | Receives |
|---|---|---|
| Recovery Coach Intervention | Experimental | Behavioral: Recovery Coach InterventionExperimental: Recovery Coach Intervention Participants randomized to the intervention arm are linked to a recovery peer coach while they are in the hospital. Recovery peer coaches are provided to the participant by Faces and Voices of Recovery (FAVOR) - Greenville. Recovery coaches are Certified Peer Support Specialists (CPSS), individuals who have firsthand experience in successful recovery and are trained in using recovery-oriented tools to help peers overcome addiction. FAVOR offers immediate access to a personal coach, a local center, and assistance to off-site intervention and recovery resources in the community. They provide twice weekly contact with participants. |
| Standard of Care Control | No intervention | –Patients in the control condition receive the current standard of care, which entails a treatment referral with a list of addiction recovery facilities, groups, and resources. It is the patient's responsibility to call a treatment facility or group on the list and thus relies on self-referral. The medical team is not permitted to call a facility or group on behalf of the patient. The physician may counsel the patient on the dangers of substance abuse and addiction, but the extent of counseling is variable and dependent on the individual physician. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18 - 60
- English speaking;
- Identified by healthcare provider as having Substance Use Disorder
- Recent substance use
- Currently admitted to the Medical Teaching Services, general medicine hospitalist services, or Infectious Disease Consult service at Greenville Memorial Hospital
Key exclusion criteria (4 listed)
- Are unable to provide informed consent (intubation, confusion, etc.) during hospitalization
- Are admitted for marijuana use only
- Are admitted for cocaine use only
- Are pregnant
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 |
|---|---|---|
| Recovery Coach InterventionParticipants randomized to the intervention arm are linked to a recovery peer coach while they are in the hospital. Recovery peer coaches are provided to the participant by Faces and Voices of Recovery (FAVOR) - Greenville. Recovery coaches are Certified Peer Support Specialists (CPSS), individuals who have firsthand experience in successful recovery and are trained in using recovery-oriented tools to help peers overcome addiction. FAVOR offers immediate access to a personal coach, a local center, and assistance to off-site intervention and recovery resources in the community. They provide twice weekly contact with participants. | Behavioural | Recovery Coach Intervention |
Primary outcome
Change in Social Support
Time frame: intervals of 1, 2, 3, and 6 months post-baseline assessment
Participants will complete the 5-item Social Support subscale of the Assessment of Recovery Capital (ARC) to assess social support. The difference between the post-baseline and baseline measures will be assessed.
Change in Financial Barriers to SUD Recovery
Time frame: intervals of 1, 2, 3, and 6 months post-baseline assessment
These barriers include lack of stable housing, transportation, and cost of recovery services. Participants will complete the Housing and Safety Subscale of the Assessment of Recovery Capital (ARC) to assess social support and housing stability. The difference between the post-baseline and baseline measures will be assessed.
Change in Situational Barriers to SUD Recovery
Time frame: intervals of 1, 2, 3, and 6 months post-baseline assessment
The barriers measured will be (1) long delays for treatment, (2) complexity of navigating the healthcare system, (3) lack of programs in one's community, (4)lack of professional help, (4) and not knowing where to go for help. The response options are binary (yes, they think this is a barrier to their recovery', or 'no, not a barrier to recovery'). Responses to these questions (0=no, 1=yes) will be summed to determine situational barriers. The difference between the post-baseline and baseline measures will be assessed.
Change in Inhibitory Control
Time frame: baseline and 6 months post-baseline assessment
Inhibitory control will be assessed behaviorally using a 150 - 200 trial computerized 'Stop Signal' Task, the most common measure of this construct. Stop Signal Reaction Time (SSRT) and Stop trial accuracy will be measured and compared across time points.
Change in Resting State EEG beta poewer
Time frame: baseline and 6 months post-baseline assessment
We will measure both absolute and relative powers for beta (14-25 Hz) bands using a 24-channel Soterix Medical EEG.
Change in Striatal Dopaminergic Functioning
Time frame: baseline and 6 months post-baseline assessment
Consistent with previous research, we will assess average spontaneous eyeblink rate, a well-validated indirect proxy for available levels of striatal tonic dopamine.
Change in Risk-Taking
Time frame: baseline and 6 months post-baseline assessment
Risk-taking will be measured using the 7-item Risk Propensity Scale (Meertens \& Lion, 2008). Higher scores on this scale indicate greater risk-taking propensity.
Change in Emotion Regulation
Time frame: baseline and 6 months post-baseline assessment
The Emotion Regulation Questionnaire (ERQ-10) will be used to assess these emotion regulation strategies and skills.
Change in Goal-Related Activities
Time frame: baseline and 6 months post-baseline assessment
Participants will complete the 5-item Meaningful Activities from the Assessment of Recovery Capital questionnaire. The 5 items will be summed for a total score.
5 secondary outcomes
Engagement in Recovery Services
Time frame: intervals of 1, 2, 3, and 6 months post-baseline assessment
Hospital Visit Frequency
Time frame: six months pre- and post-baseline assessment
Substance Use Severity
Time frame: intervals of 1, 2, 3, and 6 months post-baseline assessment
Emotional Well-being
Time frame: intervals of 1, 2, 3, and 6 months post-baseline assessment
Life Satisfaction
Time frame: intervals of 1, 2, 3, and 6 months post-baseline assessment
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 4 Nov 2024.
- Derived from this study: PubMed 35296984Cupp JA, Byrne KA, Herbert K, Roth PJ. Acute Care Utilization After Recovery Coaching Linkage During Substance-Related Inpatient Admission: Results of Two Randomized Controlled Trials. J Gen Intern Med. 2022 Aug;37(11):2768-2776. doi: 10.1007/s11606-021-07360-w. Epub 2022 Mar 16.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recovery Coach Intervention in people with Substance Use Disorders, run by Prisma Health-Upstate at 1 site 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 5 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 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Change in Social Support (time frame: intervals of 1, 2, 3, and 6 months post-baseline assessment). The study lists 9 primary outcomes in all. 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 NCT04098614, 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 4 Nov 2024.