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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in United States

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 groups in NCT01465555
Study groupRoleWhat they receive
Clinical AlertExperimentalCounselors 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 UsualNo interventionCounselors 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.

  1. 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)
  1. 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

  2. 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

  3. 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.

  1. First posted7 Nov 2011 (estimated)
  2. Study startJan 2010
  3. Primary completionDec 2013
  4. Study completionDec 2013

Resources

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)
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

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.

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