Cocaine DependenceNCT03662529
Neurobehavioral Measurement of Substance Users in Outpatient Treatment Setting
A study testing Four-Session Mind Freedom Plan and Treatment as usual therapy in people with Cocaine Dependence and Cocaine Use Disorder, run by Hunter Holmes Mcguire Veteran Affairs Medical Center at 1 site in United States.
Trial summary
This study was an internal program effectiveness evaluation of the effects of a four-session weekly individualized cognitive therapy program (called the "Mind Freedom Plan" (MFP)) on substance use outcomes and substance abuse treatment retention in Veterans admitted to an intensive outpatient treatment program for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cocaine Dependence, Cocaine Use Disorder, Opiate Dependence
- What is being tested?
- Four-Session Mind Freedom Plan and Treatment as usual therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2017to 1 Feb 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Enrollment in the Substance Abuse Treatment Program - Intensive Outpatient Program
- Currently meets criteria for an Alcohol or Substance Use Disorder per SUD clinic intake
Who cannot join
- Unable to read and speak English
- Currently active-duty military
- Current engaged with legal involvement that is mandating the completion of the substance use program.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, 23249
About this study
Official title: Neurobehavioral Measurement of Substance Users in an Outpatient Treatment Setting
This study was an internal program effectiveness evaluation of the effects of a four-session weekly individualized cognitive therapy program (called the "Mind Freedom Plan" (MFP)) on substance use outcomes and substance abuse treatment retention in Veterans admitted to an intensive outpatient treatment program for substance abuse at the Richmond Veterans Administration Medical Center (RICVAMC). Substance use and treatment retention metrics of MFP-assigned Veterans were compared with those of Veterans assigned to typical case-management-oriented weekly individual sessions.
Read the detailed description
This study was funded and launched as an internal program evaluation regarding the effects of a four-session weekly individualized cognitive therapy program called the "Mind Freedom Plan" (MFP) on substance use outcomes, impulsivity, and substance abuse treatment retention in veterans admitted to the intensive outpatient (treatment) program (IOP) for substance abuse at the Richmond Virginia Hunter Holmes McGuire Veterans Administration Medical Center (RICVAMC). Substance use and treatment retention outcomes were compared between veterans randomly assigned to the MFP versus treatment as usual (TAU), which consisted of typical case-management-oriented weekly individual sessions. Veteran participants were approached and consented within a week of admission to the RICVAMC IOP and randomly assigned to either an MFP or TAU practitioner. Assignment was constrained by practitioner new-patient availability in order to place veterans into individualized care sessions as soon as possible.
Participants completed self-reported and interview-based mood, personality and addiction severity assessments at study entry. After one month, participants were reassessed with psychometric symptomatology questionnaires, and also completed a 60-minute neurobehavioral testing session in a follow-up appointment. Subjects completed the Delis-Kaplan Executive Function System (DKEFS) Tower Test of planning ability, along with a delay-discounting decision-making task, a stop-signal task, and a go-nogo behavior inhibition task that used emotional and expressionless faces as stimuli.
- Conditions
- Cocaine Dependence, Cocaine Use Disorder, Opiate Dependence, Opioid-use Disorder, Cannabis Dependence
- Being tested
- Four-Session Mind Freedom Plan, Treatment as usual therapy
- Medical subject headings
- Cocaine-Related Disorders, Opioid-Related Disorders, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Four-Session Mind Freedom PlanBehavioural
Also called Mind Freedom Plan
Problem-solving-focused individualized cognitive behavioral therapy (CBT) that featured homework-worksheets to reinforce session-concepts.
Treatment as usual therapyBehavioural
Also called Treatment as usual
Therapy was mostly supportive therapy with an emphasis problem solving on increasing veteran motivation. A discussion of the antecedents to relapse would take place if a relapse occurred and coping skills were discussed and reviewed.
| Study group | Role | What they receive |
|---|---|---|
| Mind Freedom Plan therapy sessions | Experimental | The Four-Session Mind Freedom Plan (MFP) is cognitive behavioral therapy (CBT)-based, client-centered, manualized individual therapy that functions as part of intensive outpatient substance abuse treatment. The MFP model is based on efficacious brief interventions, with content and format driven from military veteran feedback. The four 60-minute MFP sessions were one-on-one private consultations with a therapist that were focused on identifying and changing unhealthy thinking and behavioral patterns as core elements of CBT, but with an emphasis on problem-solving, coping skills, goal setting, and psychosocial functioning. At each session, structured worksheets were utilized and homework was assigned to facilitate this CBT-based skill building. Receives: Behavioral: Four-Session Mind Freedom Plan |
| Treatment as usual therapy | Active comparator | The four 50-minute TAU sessions were one-on-one individual therapy sessions. Therapy was mostly supportive therapy with an emphasis problem solving on increasing veteran motivation. A discussion of the antecedents to relapse would take place if a relapse occurred and coping skills were discussed and reviewed. Veterans were also connected with community-level psychosocial supports as appropriate. Receives: Behavioral: Treatment as usual therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of patients who completed the Substance Abuse Treatment Program (SATP) Intensive Outpatient Program (IOP).
Chart review variable; SATP IOP patients are designated as completers vs non-completers by their IOP social worker. IOP treatment retention outcome is documented in the patients' charts as part of standard care.
Measured: 28-Day
Rate of abstinence during final week of intensive outpatient therapy (IOP)
Chart review variable; abstinence in the final week of IOP was defined as urine drug screen (UDS) negative and no self-reported substance use by the final week of IOP. UDS results and self-reported substance use are documented in the patients' charts as part of standard care.
Measured: 21-28 Days
Secondary outcomes (7)
Drug use during outpatient therapy
Proportion of drug-negative urine samples during 4-week outpatient treatment
Measured: 1-28 Days
Decision-based impulsivity
Severity of delay-discounting behavior in laboratory task
Measured: 28 Days
Rapid-response impulsivity
Stop signal reaction time (SSRT) in stop-signal computer task
Measured: 28 Days
Problem-solving ability
Mean difference in Delis-Kaplan Executive Function System (D-KEFS) Tower Subtest total score at 4-week follow up with MFP vs TAU. The D-KEFS Tower Test is a cognitive test for executive functioning, planning, and problem-solving ability. During the D-KEFS Tower Test, participants are instructed to create towers using discs and a set of pegs that correspond to a model. D-KEFS Tower Test total scores range from 0 to 30, with higher scores indicating a better performance on the tower building task.
Measured: 28 Days
Depression symptomatology
Change in Beck Depression Inventory (BDI)-II total scores from baseline to 4-week follow up with MFP vs TAU. Depressive symptom severity was measured with the total score of the 21-item BDI-II. BDI-II total scores range from 0 to 63, with higher scores represent increased depressive symptoms.
Measured: Pre-treatment baseline and 28 Days
Quality of life as assessed by the Quality of Life Inventory (QoLI) total score.
Change in Quality of Life Inventory (QoLI) total scores from baseline to 4-week follow up with MFP vs TAU. The QoLI is a 32-item self-report instrument that assesses positive mental health, wellbeing, and happiness using an overall score across 16 life domains (e.g., health, work). Participants rate how important each domain is (0-2 scale) and how satisfied they are with this area of their life (7-point scale). QoLI satisfaction scores are weighted based on importance rating in order to create a total score.
Measured: Pre-treatment baseline and 28 Days
Impulsive personality
Change in Barratt Impulsiveness Scale (BIS-11) total scores from baseline to 4-week follow up with MFP vs TAU. Total score on the 30-item (4-point scale) BIS-11 is a self-report measure of trait impulsivity, with higher scores reflecting increased impulsivity.
Measured: Pre-treatment baseline and 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start5 Jun 2017
- Primary completion8 Jan 2018
- Study completion1 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine DependenceStudies 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
- Participants were effectively block-randomized either into individual treatment as usual (TAU)(practitioners who administered TAU) OR individual therapy with the study intervention (Mind Freedom Plan), where data from both arms was collected in parallel.
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hunter Holmes Mcguire Veteran Affairs Medical Center
- Sponsor type
- US federal agency
- Collaborators
- VA Mental Illness Research, Education and Clinical Centers
- Responsible party
- Principal investigator, James Bjork, Hunter Holmes Mcguire Veteran Affairs Medical Center
- Investigators
- James M Bjork, PhD, Principal investigator, Hunter Holmes McGuire VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03662529
- Sponsor's protocol ID
- 02287
- Status last verified
- Sep 2018
- First submitted
- 17 Aug 2018
- Last updated
- 7 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurobehavioral Measurement of Substance Users in an Outpatient Treatment Setting
- ClinicalTrials.gov ID
- NCT03662529
- Acronym / sponsor ID
- 02287
- Conditions
- Cocaine Dependence, Cocaine Use Disorder, Opiate Dependence, Opioid-use Disorder, Cannabis Dependence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Hunter Holmes Mcguire Veteran Affairs Medical CenterUS federal agency
- Collaborators
- VA Mental Illness Research, Education and Clinical Centers
- Study start
- 5 Jun 2017 (actual)
- Primary completion
- 8 Jan 2018 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 7 Sep 2018 (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.
This study was an internal program effectiveness evaluation of the effects of a four-session weekly individualized cognitive therapy program (called the "Mind Freedom Plan" (MFP)) on substance use outcomes and substance abuse treatment retention in Veterans admitted to an intensive outpatient treatment program for substance abuse at the Richmond Veterans Administration Medical Center (RICVAMC). Substance use and treatment retention metrics of MFP-assigned Veterans were compared with those of Veterans assigned to typical case-management-oriented weekly individual sessions.
Detailed description
This study was funded and launched as an internal program evaluation regarding the effects of a four-session weekly individualized cognitive therapy program called the "Mind Freedom Plan" (MFP) on substance use outcomes, impulsivity, and substance abuse treatment retention in veterans admitted to the intensive outpatient (treatment) program (IOP) for substance abuse at the Richmond Virginia Hunter Holmes McGuire Veterans Administration Medical Center (RICVAMC). Substance use and treatment retention outcomes were compared between veterans randomly assigned to the MFP versus treatment as usual (TAU), which consisted of typical case-management-oriented weekly individual sessions. Veteran participants were approached and consented within a week of admission to the RICVAMC IOP and randomly assigned to either an MFP or TAU practitioner. Assignment was constrained by practitioner new-patient availability in order to place veterans into individualized care sessions as soon as possible.
Participants completed self-reported and interview-based mood, personality and addiction severity assessments at study entry. After one month, participants were reassessed with psychometric symptomatology questionnaires, and also completed a 60-minute neurobehavioral testing session in a follow-up appointment. Subjects completed the Delis-Kaplan Executive Function System (DKEFS) Tower Test of planning ability, along with a delay-discounting decision-making task, a stop-signal task, and a go-nogo behavior inhibition task that used emotional and expressionless faces as stimuli.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were effectively block-randomized either into individual treatment as usual (TAU)(practitioners who administered TAU) OR individual therapy with the study intervention (Mind Freedom Plan), where data from both arms was collected in parallel.
| Arm | Type | Receives |
|---|---|---|
| Mind Freedom Plan therapy sessions | Experimental | Behavioral: Four-Session Mind Freedom PlanThe Four-Session Mind Freedom Plan (MFP) is cognitive behavioral therapy (CBT)-based, client-centered, manualized individual therapy that functions as part of intensive outpatient substance abuse treatment. The MFP model is based on efficacious brief interventions, with content and format driven from military veteran feedback. The four 60-minute MFP sessions were one-on-one private consultations with a therapist that were focused on identifying and changing unhealthy thinking and behavioral patterns as core elements of CBT, but with an emphasis on problem-solving, coping skills, goal setting, and psychosocial functioning. At each session, structured worksheets were utilized and homework was assigned to facilitate this CBT-based skill building. |
| Treatment as usual therapy | Active comparator | Behavioral: Treatment as usual therapyThe four 50-minute TAU sessions were one-on-one individual therapy sessions. Therapy was mostly supportive therapy with an emphasis problem solving on increasing veteran motivation. A discussion of the antecedents to relapse would take place if a relapse occurred and coping skills were discussed and reviewed. Veterans were also connected with community-level psychosocial supports as appropriate. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Enrollment in the Substance Abuse Treatment Program - Intensive Outpatient Program
- Currently meets criteria for an Alcohol or Substance Use Disorder per SUD clinic intake
Key exclusion criteria (3 listed)
- Unable to read and speak English
- Currently active-duty military
- Current engaged with legal involvement that is mandating the completion of the substance use program.
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 |
|---|---|---|
| Four-Session Mind Freedom PlanAlso: Mind Freedom PlanProblem-solving-focused individualized cognitive behavioral therapy (CBT) that featured homework-worksheets to reinforce session-concepts. | Behavioural | Mind Freedom Plan therapy sessions |
| Treatment as usual therapyAlso: Treatment as usualTherapy was mostly supportive therapy with an emphasis problem solving on increasing veteran motivation. A discussion of the antecedents to relapse would take place if a relapse occurred and coping skills were discussed and reviewed. | Behavioural | Treatment as usual therapy |
Primary outcome
Percent of patients who completed the Substance Abuse Treatment Program (SATP) Intensive Outpatient Program (IOP).
Time frame: 28-Day
Chart review variable; SATP IOP patients are designated as completers vs non-completers by their IOP social worker. IOP treatment retention outcome is documented in the patients' charts as part of standard care.
Rate of abstinence during final week of intensive outpatient therapy (IOP)
Time frame: 21-28 Days
Chart review variable; abstinence in the final week of IOP was defined as urine drug screen (UDS) negative and no self-reported substance use by the final week of IOP. UDS results and self-reported substance use are documented in the patients' charts as part of standard care.
7 secondary outcomes
Drug use during outpatient therapy
Time frame: 1-28 Days
Decision-based impulsivity
Time frame: 28 Days
Rapid-response impulsivity
Time frame: 28 Days
Problem-solving ability
Time frame: 28 Days
Depression symptomatology
Time frame: Pre-treatment baseline and 28 Days
Quality of life as assessed by the Quality of Life Inventory (QoLI) total score.
Time frame: Pre-treatment baseline and 28 Days
Impulsive personality
Time frame: Pre-treatment baseline and 28 Days
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 7 Sep 2018.
- Individual participant dataSharing planned: No
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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.
James M Bjork, PhD principal investigator
Hunter Holmes McGuire VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Four-Session Mind Freedom Plan and Treatment as usual therapy in people with Cocaine Dependence and Cocaine Use Disorder, run by Hunter Holmes Mcguire Veteran Affairs Medical Center 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 2 inclusion and 3 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 7 Sep 2018. 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?
Percent of patients who completed the Substance Abuse Treatment Program (SATP) Intensive Outpatient Program (IOP). (time frame: 28-Day). The study lists 2 primary outcomes in all. 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 7 Sep 2018.