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Completed

NCT Number: NCT03662529

Neurobehavioral Measurement of Substance Users in 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.

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Key information

Conditions

Cocaine Dependence Cannabis Dependence Chemically-Induced Disorders Cocaine Use Disorder Cocaine-Related Disorders Marijuana Abuse Mental Disorders Narcotic-Related Disorders Opiate Dependence Opioid-Related Disorders Opioid-use Disorder Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, 23249, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Four-Session Mind Freedom Plan

Behavioral

Problem-solving-focused individualized cognitive behavioral therapy (CBT) that featured homework-worksheets to reinforce session-concepts.

Other names: Mind Freedom Plan

Treatment as usual therapy

Behavioral

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: Treatment as usual

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Drug use during outpatient therapy

    Time frame: 1-28 Days

    Proportion of drug-negative urine samples during 4-week outpatient treatment

  2. Decision-based impulsivity

    Time frame: 28 Days

    Severity of delay-discounting behavior in laboratory task

  3. Rapid-response impulsivity

    Time frame: 28 Days

    Stop signal reaction time (SSRT) in stop-signal computer task

  4. Problem-solving ability

    Time frame: 28 Days

    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.

  5. Depression symptomatology

    Time frame: Pre-treatment baseline and 28 Days

    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.

  6. Quality of life as assessed by the Quality of Life Inventory (QoLI) total score.

    Time frame: Pre-treatment baseline and 28 Days

    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.

  7. Impulsive personality

    Time frame: Pre-treatment baseline and 28 Days

    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.

Sponsors and collaborators

Lead sponsor

Hunter Holmes Mcguire Veteran Affairs Medical Center

Fed

Collaborators

  • VA Mental Illness Research, Education and Clinical Centers

Registry information

Official study title

Neurobehavioral Measurement of Substance Users in an Outpatient Treatment Setting

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 7, 2018
Registry last updated
Sep 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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