Substance AbusePhase 1/2NCT01465555
Evaluation of Web-Based Recovery Monitoring With Clinical Alerts
A Phase 1/2 study testing Cognitive Behavioral Intervention in people with Substance Abuse, run by Treatment Research Institute at 4 sites in United States.
Trial summary
The specific aims of the project are to conduct a three-phase study to develop a data-driven Clinical Alert feature to the RecoveryTrack™ Concurrent Recovery Monitoring (CRM) system and test its efficacy, as follows: Phase I - Analyze RecoveryTrack and outcomes data to create a clinical algorithm that predicts early… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Abuse
- What is being tested?
- Cognitive Behavioral Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 389 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2010to Dec 2013
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Client enrolled in outpatient treatment at participating facility and assigned to participating counselor.
- Counselor employed at participating facility.
Who cannot join
- Client unable to speak English
- Client too cognitively impaired to give informed consent
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Genesis Counseling Centers
Collingswood, New Jersey, 08108
Kent Sussex Counseling Services
Dover, Delaware, 19904
Sobriety Through Outpatient
Philadelphia, Pennsylvania, 19132
Brandywine Counseling & Community Services
Wilmington, Delaware, 19805
About this study
The specific aims of the project are to conduct a three-phase study to develop a data-driven Clinical Alert feature to the RecoveryTrack™ Concurrent Recovery Monitoring (CRM) system and test its efficacy, as follows:
Phase I - Analyze RecoveryTrack and outcomes data to create a clinical algorithm that predicts early treatment attrition; adapt elements of a cognitive behavioral intervention (CBI) for use in addressing Clinical Alerts, as well as adapting training and adherence measures; reprogram RecoveryTrack with a Clinical Alert feature for each of the first three monitoring assessments to inform counselors when a client is at High Risk to leave treatment.
Read more
Phase II -Conduct a feasibility trial to refine Clinical Alerts + CBI intervention and the study measures/procedures.
Phase III - Conduct a pilot randomized clinical trial comparing outcomes of clients whose counselors were randomized to Clinical Alerts + CBI to those of clients whose counselors were assigned to TAU (control condition). The primary hypothesis is that clients who evidence a High Risk for attrition will have longer lengths of stay in the Clinical Alerts + CBI condition than High Risk clients in the control condition. Secondary client hypotheses are that High Risk clients in the Clinical Alert + CBI condition will attend more treatment sessions, have more drug-free urine results, and receive more ancillary services than High Risk clients in the control condition.
Read the detailed description
Phase 1:Our study team completed Phase I of the project in June, 2011. Our initial plans called for our team to analyze RT data that was collected by Delaware treatment programs to determine specific predictors for early attrition from treatment. Eleven counselors were trained to use RT as part of their standard practice in May, 2011. In an effort to generate a predictive algorithm for Phase II, we analyzed data from three datasets available from IRB approved research projects. However, the results were inconclusive, possibly due to small sample sizes and differences in the recruitment and definition of drop out across samples. In order to proceed with Phase II, we created an algorithm based largely on severity of substance use, a consistent predictor of drop-out across the alcohol and illicit substance literature; the algorithm also addresses when clients are not using but their Risk factors greatly outweigh the influence of Protective factors. We determined that the algorithm did work to identify clients who self-reported using substances or high levels of risk. However, the identification rate of high-risk cases was too low, and so we modified the algorithm to identify: 1) clients with high use at baseline, 2) clients with positive urine samples, 3) clients with any use at subsequent [post-baseline] interviews, and 4) clients whose risk factors outweighed their protective factors. This increased our rate of identification of risk cases by about 32%.
As part of Phase I, we also completed the programming changes to RT to add a Clinical Alert feature that informs counselors when a client is at high risk based on the algorithm. The CBI intervention and training materials for Phase II was created. We developed the CBI into a brief clinical "toolkit" that enabled counselors to respond to clinical risk based on their judgment. This Toolkit allows counselors to exercise clinical judgment to determine whether clients are generating a Clinical Alert because 1) they are using drugs or alcohol, or are at risk to start using, 2) they have unmet psychosocial needs [i.e., need for psychiatric consultation], or 3) they have a poor alliance with the counselor / treatment provider and need some help building on the relationship. The Clinical Alert Toolkit included a series of exercises / interventions that counselors could deploy once they had determined which of the client's needs were most pressing (either based on their own judgment or in agreement with the client).
Phase 2:Three counselors consented to participate in this study and were trained to use RT in May, 2011 and were trained on the CBI intervention in June, 2011. Recruitment of client participants began in July, 2011. The training and intervention materials were well received by the participating counselors. One counselor ended their employment prior to the research staff beginning client recruitment. 30 clients out of 35 who were approached participated in the feasibility trial; 28 clients completed baseline (93%), 23 completed the one month follow up (77%), 21 completed the two month follow up (70%), and 21 completed the three month follow up (70%). Out of these clients, two clients were incarcerated for their 1 month follow up window, 2 clients were incarcerated for their 2 month follow up window, and three clients were incarcerated for their three month follow up window therefore they were not approached to complete the follow-up interview. We used our experiences during Phase II to make several changes in our training and clinical protocol for counselors to follow. We revised several of our Toolkit components (specifically the worksheets to make them more user-friendly and to reduce training burden). We also simplified our feedback strategy which took place during the clinical supervision sessions to focus much less on general therapeutic skills and more specifically on actual compliance with the trained Clinical Alert CBI. Additionally, we found that while our Phase II training counselors verbalized motivation to try to learn to use the CBI techniques, that the learning curve was slower than we desired, and we decided to employ a contingency management feedback strategy to increase their incentive to acquire the basic elements of the CBI more quickly. This revision required IRB approval; in the revised approach, counselors could earn bonuses when a rated audio recorded session showed that they had been at least minimally adherent in delivering the CBI. Finally, during Phase II we completed the Attention Control training (focused on treatment planning) for use in the TAU condition.
Phase 3: Because we needed to move the study from Delaware Site 1 (our original clinical site and partner), our team recruited Alternate Site 1 in Philadelphia and Alternate Site 2 in central New Jersey to conduct the Phase III clinical pilot trial. We enrolled 20 counselors who were trained to use RT on a monthly basis with their clients, starting at the first scheduled individual session and monthly thereafter. We randomly assigned these counselors to receive either TAU treatment planning training or to receive Clinical Alert (CA) training. After training, recruitment began. During the trial, three counselors in the CA condition either were noncompliant with the study protocol (N = 2), or never had any clients report any high risk (N = 1). We worked with all three of these counselors to encourage improved engagement with the intervention and study procedures, but this was not successful. Consequently, we decided that we would over-recruit additional counselors into the CA condition, to create additional opportunities to determine whether the Clinical Alerts + Intervention training would impact outcomes. We recruited an additional three counselors, but did not randomize them; rather, we assigned them directly to the CA condition.
We enrolled 336 clients in Phase 3. 142 self-reported clinical RT data which would result in a Clinical Alert profile (TAU: N = 78, CA: N = 64). Because of a low recruitment rate, the study was severely underpowered for our subanalyses to examine specific effects of the intervention training on dealing with High Risk cases; this is where we believed our strongest effects would present themselves.
- Conditions
- Substance Abuse
- Being tested
- Cognitive Behavioral Intervention
- Keywords
- Clinical Alert, Cognitive Behavioral Intervention, Web-based, Substance Abuse Treatment
- 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.
Cognitive Behavioral InterventionBehavioural
Counselors in this condition will work with the modified RecoveryTrack tested in the pilot study which has been altered to provide automated Clinical Alerts at either the intake, Month 1, or Month 2 CRM interview for High Risk patients. In addition, High Risk patients will be flagged in the counselor's caseload for discussion with clinical supervisors. Counselors in this condition will receive the Clinical Alert + Cognitive Behavioral Intervention (CBI) training, as well as monthly feedback from the Principal Investigator on their delivery of the CBI Months 1-3, with a booster session at Month 6.
| Study group | Role | What they receive |
|---|---|---|
| Clinical Alert | Experimental | Counselors in this condition will work with the modified RecoveryTrack tested in the pilot study which has been altered to provide automated Clinical Alerts at either the intake, Month 1, or Month 2 CRM interview for High Risk patients. In addition, High Risk patients will be flagged in the counselor's caseload for discussion with clinical supervisors. Counselors in this condition will receive the Clinical Alert + Cognitive Behavioral Intervention (CBI) training, as well as monthly feedback from the Principal Investigator on their delivery of the CBI Months 1-3, with a booster session at Month 6. Receives: Behavioral: Cognitive Behavioral Intervention |
| Treatment As Usual | No intervention | Counselors in this condition will work with the original RecoveryTrack which has not been altered to provide automated Clinical Alerts for High Risk patients. Supervisors will receive no automated help in identifying these clients in the counselors' caseloads. The Clinical Alert feature will not be discussed in the training these counselors receive. Rather, the counselors will receive an attention-control training, a one-day training on assessment and treatment planning, with monthly tips and reminders for six months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay
Client admission and discharge dates will be obtained from the treatment program clinical record and used to calculate length of stay.
Measured: 3 months post consent
Secondary outcomes (3)
Number of treatment sessions
The number of treatment sessions the client attended will be obtained from the treatment program clinical record.
Measured: 3 months after consent
Urine drug screen results
The urine drug screen results for each client will be obtained from the treatment program clinical record.
Measured: 3 months post consent
Number of treatment services
Number of treatment services will be obtained from the client as self report at the 1, 2, and 3 Month follow-up.
Measured: 3 months post consent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2011 (estimated)
- Study startJan 2010
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance AbuseStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 389 participants (actual)
Sponsor and investigators
- Lead sponsor
- Treatment Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Adam C Brooks, Ph.D., Principal investigator, Treatment Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01465555
- Sponsor's protocol ID
- R01DA026469
- Other IDs
- R01DA026469
- Status last verified
- Mar 2023
- First submitted
- 1 Nov 2011
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Web-Based Recovery Monitoring With Clinical Alerts
- ClinicalTrials.gov ID
- NCT01465555
- Acronym / sponsor ID
- R01DA026469
- Conditions
- Substance Abuse
- Keywords
- Clinical Alert, Cognitive Behavioral Intervention, Web-based, Substance Abuse Treatment
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 389 participants (actual)
- Lead sponsor
- Treatment Research InstituteUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jan 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 7 Nov 2011 (estimated)
- 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 specific aims of the project are to conduct a three-phase study to develop a data-driven Clinical Alert feature to the RecoveryTrack™ Concurrent Recovery Monitoring (CRM) system and test its efficacy, as follows:
Phase I - Analyze RecoveryTrack and outcomes data to create a clinical algorithm that predicts early treatment attrition; adapt elements of a cognitive behavioral intervention (CBI) for use in addressing Clinical Alerts, as well as adapting training and adherence measures; reprogram RecoveryTrack with a Clinical Alert feature for each of the first three monitoring assessments to inform counselors when a client is at High Risk to leave treatment.
Phase II -Conduct a feasibility trial to refine Clinical Alerts + CBI intervention and the study measures/procedures.
Phase III - Conduct a pilot randomized clinical trial comparing outcomes of clients whose counselors were randomized to Clinical Alerts + CBI to those of clients whose counselors were assigned to TAU (control condition). The primary hypothesis is that clients who evidence a High Risk for attrition will have longer lengths of stay in the Clinical Alerts + CBI condition than High Risk clients in the control condition. Secondary client hypotheses are that High Risk clients in the Clinical Alert + CBI condition will attend more treatment sessions, have more drug-free urine results, and receive more ancillary services than High Risk clients in the control condition.
Detailed description
Phase 1:Our study team completed Phase I of the project in June, 2011. Our initial plans called for our team to analyze RT data that was collected by Delaware treatment programs to determine specific predictors for early attrition from treatment. Eleven counselors were trained to use RT as part of their standard practice in May, 2011. In an effort to generate a predictive algorithm for Phase II, we analyzed data from three datasets available from IRB approved research projects. However, the results were inconclusive, possibly due to small sample sizes and differences in the recruitment and definition of drop out across samples. In order to proceed with Phase II, we created an algorithm based largely on severity of substance use, a consistent predictor of drop-out across the alcohol and illicit substance literature; the algorithm also addresses when clients are not using but their Risk factors greatly outweigh the influence of Protective factors. We determined that the algorithm did work to identify clients who self-reported using substances or high levels of risk. However, the identification rate of high-risk cases was too low, and so we modified the algorithm to identify: 1) clients with high use at baseline, 2) clients with positive urine samples, 3) clients with any use at subsequent [post-baseline] interviews, and 4) clients whose risk factors outweighed their protective factors. This increased our rate of identification of risk cases by about 32%.
As part of Phase I, we also completed the programming changes to RT to add a Clinical Alert feature that informs counselors when a client is at high risk based on the algorithm. The CBI intervention and training materials for Phase II was created. We developed the CBI into a brief clinical "toolkit" that enabled counselors to respond to clinical risk based on their judgment. This Toolkit allows counselors to exercise clinical judgment to determine whether clients are generating a Clinical Alert because 1) they are using drugs or alcohol, or are at risk to start using, 2) they have unmet psychosocial needs [i.e., need for psychiatric consultation], or 3) they have a poor alliance with the counselor / treatment provider and need some help building on the relationship. The Clinical Alert Toolkit included a series of exercises / interventions that counselors could deploy once they had determined which of the client's needs were most pressing (either based on their own judgment or in agreement with the client).
Phase 2:Three counselors consented to participate in this study and were trained to use RT in May, 2011 and were trained on the CBI intervention in June, 2011. Recruitment of client participants began in July, 2011. The training and intervention materials were well received by the participating counselors. One counselor ended their employment prior to the research staff beginning client recruitment. 30 clients out of 35 who were approached participated in the feasibility trial; 28 clients completed baseline (93%), 23 completed the one month follow up (77%), 21 completed the two month follow up (70%), and 21 completed the three month follow up (70%). Out of these clients, two clients were incarcerated for their 1 month follow up window, 2 clients were incarcerated for their 2 month follow up window, and three clients were incarcerated for their three month follow up window therefore they were not approached to complete the follow-up interview. We used our experiences during Phase II to make several changes in our training and clinical protocol for counselors to follow. We revised several of our Toolkit components (specifically the worksheets to make them more user-friendly and to reduce training burden). We also simplified our feedback strategy which took place during the clinical supervision sessions to focus much less on general therapeutic skills and more specifically on actual compliance with the trained Clinical Alert CBI. Additionally, we found that while our Phase II training counselors verbalized motivation to try to learn to use the CBI techniques, that the learning curve was slower than we desired, and we decided to employ a contingency management feedback strategy to increase their incentive to acquire the basic elements of the CBI more quickly. This revision required IRB approval; in the revised approach, counselors could earn bonuses when a rated audio recorded session showed that they had been at least minimally adherent in delivering the CBI. Finally, during Phase II we completed the Attention Control training (focused on treatment planning) for use in the TAU condition.
Phase 3: Because we needed to move the study from Delaware Site 1 (our original clinical site and partner), our team recruited Alternate Site 1 in Philadelphia and Alternate Site 2 in central New Jersey to conduct the Phase III clinical pilot trial. We enrolled 20 counselors who were trained to use RT on a monthly basis with their clients, starting at the first scheduled individual session and monthly thereafter. We randomly assigned these counselors to receive either TAU treatment planning training or to receive Clinical Alert (CA) training. After training, recruitment began. During the trial, three counselors in the CA condition either were noncompliant with the study protocol (N = 2), or never had any clients report any high risk (N = 1). We worked with all three of these counselors to encourage improved engagement with the intervention and study procedures, but this was not successful. Consequently, we decided that we would over-recruit additional counselors into the CA condition, to create additional opportunities to determine whether the Clinical Alerts + Intervention training would impact outcomes. We recruited an additional three counselors, but did not randomize them; rather, we assigned them directly to the CA condition.
We enrolled 336 clients in Phase 3. 142 self-reported clinical RT data which would result in a Clinical Alert profile (TAU: N = 78, CA: N = 64). Because of a low recruitment rate, the study was severely underpowered for our subanalyses to examine specific effects of the intervention training on dealing with High Risk cases; this is where we believed our strongest effects would present themselves.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical Alert | Experimental | Behavioral: Cognitive Behavioral InterventionCounselors in this condition will work with the modified RecoveryTrack tested in the pilot study which has been altered to provide automated Clinical Alerts at either the intake, Month 1, or Month 2 CRM interview for High Risk patients. In addition, High Risk patients will be flagged in the counselor's caseload for discussion with clinical supervisors. Counselors in this condition will receive the Clinical Alert + Cognitive Behavioral Intervention (CBI) training, as well as monthly feedback from the Principal Investigator on their delivery of the CBI Months 1-3, with a booster session at Month 6. |
| Treatment As Usual | No intervention | –Counselors in this condition will work with the original RecoveryTrack which has not been altered to provide automated Clinical Alerts for High Risk patients. Supervisors will receive no automated help in identifying these clients in the counselors' caseloads. The Clinical Alert feature will not be discussed in the training these counselors receive. Rather, the counselors will receive an attention-control training, a one-day training on assessment and treatment planning, with monthly tips and reminders for six months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Client enrolled in outpatient treatment at participating facility and assigned to participating counselor.
- Counselor employed at participating facility.
Key exclusion criteria (2 listed)
- Client unable to speak English
- Client too cognitively impaired to give informed consent
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 |
|---|---|---|
| Cognitive Behavioral InterventionCounselors in this condition will work with the modified RecoveryTrack tested in the pilot study which has been altered to provide automated Clinical Alerts at either the intake, Month 1, or Month 2 CRM interview for High Risk patients. In addition, High Risk patients will be flagged in the counselor's caseload for discussion with clinical supervisors. Counselors in this condition will receive the Clinical Alert + Cognitive Behavioral Intervention (CBI) training, as well as monthly feedback from the Principal Investigator on their delivery of the CBI Months 1-3, with a booster session at Month 6. | Behavioural | Clinical Alert |
Primary outcome
Length of stay
Time frame: 3 months post consent
Client admission and discharge dates will be obtained from the treatment program clinical record and used to calculate length of stay.
3 secondary outcomes
Number of treatment sessions
Time frame: 3 months after consent
Urine drug screen results
Time frame: 3 months post consent
Number of treatment services
Time frame: 3 months post consent
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 28 Mar 2023.
Related trials for Substance Abuse
RecruitingPhase 3
Nabilone for Agitation Blinded Intervention Trial
Alzheimer Disease, Agitation
Recruiting
The Trans-Led Care Study
Substance Abuse, Substance Addiction
Active, not recruitingPhase 1
Psilocybin-assisted Treatment for Cannabis Use Disorder
Cannabis Use Disorder
Not yet recruitingEarly Phase 1
Lung Health and Breath Biomarkers: Acute Effects of Inhaled Cannabis
Cannabis Use, Tobacco
Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence
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.
Adam C Brooks, Ph.D. principal investigator
Treatment Research Institute
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cognitive Behavioral Intervention in people with Substance Abuse, run by Treatment Research Institute at 4 sites 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 2 inclusion and 2 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 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Length of stay (time frame: 3 months post consent). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Mar 2023.