- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03662529
Neurobehavioral Measurement of Substance Users in Outpatient Treatment Setting
Neurobehavioral Measurement of Substance Users in an Outpatient Treatment Setting
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Virginia
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Richmond, Virginia, United States, 23249
- Hunter Holmes McGuire VA Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Enrollment in the Substance Abuse Treatment Program - Intensive Outpatient Program
- Currently meets criteria for an Alcohol or Substance Use Disorder per SUD clinic intake
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mind Freedom Plan therapy sessions
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.
|
Problem-solving-focused individualized cognitive behavioral therapy (CBT) that featured homework-worksheets to reinforce session-concepts.
Other Names:
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Active Comparator: Treatment as usual therapy
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.
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent of patients who completed the Substance Abuse Treatment Program (SATP) Intensive Outpatient Program (IOP).
Time Frame: 28-Day
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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.
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28-Day
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Rate of abstinence during final week of intensive outpatient therapy (IOP)
Time Frame: 21-28 Days
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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.
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21-28 Days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Drug use during outpatient therapy
Time Frame: 1-28 Days
|
Proportion of drug-negative urine samples during 4-week outpatient treatment
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1-28 Days
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Decision-based impulsivity
Time Frame: 28 Days
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Severity of delay-discounting behavior in laboratory task
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28 Days
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Rapid-response impulsivity
Time Frame: 28 Days
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Stop signal reaction time (SSRT) in stop-signal computer task
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28 Days
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Problem-solving ability
Time Frame: 28 Days
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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.
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28 Days
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Depression symptomatology
Time Frame: Pre-treatment baseline and 28 Days
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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.
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Pre-treatment baseline and 28 Days
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Quality of life as assessed by the Quality of Life Inventory (QoLI) total score.
Time Frame: Pre-treatment baseline and 28 Days
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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.
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Pre-treatment baseline and 28 Days
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Impulsive personality
Time Frame: Pre-treatment baseline and 28 Days
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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.
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Pre-treatment baseline and 28 Days
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Collaborators and Investigators
Investigators
- Principal Investigator: James M Bjork, PhD, Hunter Holmes McGuire VA Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 02287
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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