Clinical trial NCT03662529: Neurobehavioral Measurement of Substance Users in Outpatient Treatment Setting
Official title: Neurobehavioral Measurement of Substance Users in an Outpatient Treatment Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cocaine Dependence
Cocaine Use Disorder
Opiate Dependence
Opioid-use Disorder
Cannabis Dependence
Lead sponsor: Hunter Holmes Mcguire Veteran Affairs Medical Center
Sponsor class: FED
Collaborators: name: VA Mental Illness Research, Education and Clinical Centers
First posted: 2018-09-07
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percent of patients who completed the Substance Abuse Treatment Program (SATP) Intensive Outpatient Program (IOP).
timeFrame: 28-Day
measure: Rate of abstinence during final week of intensive outpatient therapy (IOP)
timeFrame: 21-28 Days
Secondary outcomes:
measure: Drug use during outpatient therapy
timeFrame: 1-28 Days
measure: Decision-based impulsivity
timeFrame: 28 Days
measure: Rapid-response impulsivity
timeFrame: 28 Days
measure: Problem-solving ability
timeFrame: 28 Days
measure: Depression symptomatology
timeFrame: Pre-treatment baseline and 28 Days
measure: Quality of life as assessed by the Quality of Life Inventory (QoLI) total score.
timeFrame: Pre-treatment baseline and 28 Days
measure: Impulsive personality
timeFrame: Pre-treatment baseline and 28 Days
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Hunter Holmes McGuire VA Medical Center
state: Virginia
Study officials:
affiliation: Hunter Holmes McGuire VA Medical Center
name: James M Bjork, PhD
role: PRINCIPAL_INVESTIGATOR
References: