Neurobehavioral Measurement of Substance Users in Outpatient Treatment Setting

Opioid-use Disorder Clinical Trial

Official title:

Neurobehavioral Measurement of Substance Users in an Outpatient Treatment Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03662529
• Other study ID #: 02287
• Status: Completed
• Phase: N/A
• Start date: June 5, 2017
• Est. completion date: February 1, 2018

Study information

• Verified date: September 2018
• Source: Hunter Holmes Mcguire Veteran Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: February 1, 2018
• Est. primary completion date: January 8, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cannabis Dependence
• Cocaine Dependence
• Cocaine Use Disorder
• Cocaine-Related Disorders
• Disease
• Marijuana Abuse
• Opiate Dependence
• Opioid-Related Disorders
• Opioid-use Disorder

Intervention

Behavioral:
• Four-Session Mind Freedom Plan
Problem-solving-focused individualized cognitive behavioral therapy (CBT) that featured homework-worksheets to reinforce session-concepts.
• Treatment as usual therapy
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.

Locations

Country	Name	City	State
United States	Hunter Holmes McGuire VA Medical Center	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Hunter Holmes Mcguire Veteran Affairs Medical Center	VA Mental Illness Research, Education and Clinical Centers

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	28-Day
Primary	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.	21-28 Days
Secondary	Drug use during outpatient therapy	Proportion of drug-negative urine samples during 4-week outpatient treatment	1-28 Days
Secondary	Decision-based impulsivity	Severity of delay-discounting behavior in laboratory task	28 Days
Secondary	Rapid-response impulsivity	Stop signal reaction time (SSRT) in stop-signal computer task	28 Days
Secondary	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.	28 Days
Secondary	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.	Pre-treatment baseline and 28 Days
Secondary	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.	Pre-treatment baseline and 28 Days
Secondary	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.	Pre-treatment baseline and 28 Days