search
Back to results

Neurobehavioral Measurement of Substance Users in Outpatient Treatment Setting

Primary Purpose

Cocaine Dependence, Cocaine Use Disorder, Opiate Dependence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Four-Session Mind Freedom Plan
Treatment as usual therapy
Sponsored by
Hunter Holmes Mcguire Veteran Affairs Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cocaine Dependence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hunter Holmes McGuire VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mind Freedom Plan therapy sessions

Treatment as usual therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Drug use during outpatient therapy
Proportion of drug-negative urine samples during 4-week outpatient treatment
Decision-based impulsivity
Severity of delay-discounting behavior in laboratory task
Rapid-response impulsivity
Stop signal reaction time (SSRT) in stop-signal computer task
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.
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.
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.
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.

Full Information

First Posted
August 17, 2018
Last Updated
September 6, 2018
Sponsor
Hunter Holmes Mcguire Veteran Affairs Medical Center
Collaborators
VA Mental Illness Research, Education and Clinical Centers
search

1. Study Identification

Unique Protocol Identification Number
NCT03662529
Brief Title
Neurobehavioral Measurement of Substance Users in Outpatient Treatment Setting
Official Title
Neurobehavioral Measurement of Substance Users in an Outpatient Treatment Setting
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
June 5, 2017 (Actual)
Primary Completion Date
January 8, 2018 (Actual)
Study Completion Date
February 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hunter Holmes Mcguire Veteran Affairs Medical Center
Collaborators
VA Mental Illness Research, Education and Clinical Centers

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Dependence, Cocaine Use Disorder, Opiate Dependence, Opioid-use Disorder, Cannabis Dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mind Freedom Plan therapy sessions
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment as usual therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Four-Session Mind Freedom Plan
Other Intervention Name(s)
Mind Freedom Plan
Intervention Description
Problem-solving-focused individualized cognitive behavioral therapy (CBT) that featured homework-worksheets to reinforce session-concepts.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as usual therapy
Other Intervention Name(s)
Treatment as usual
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent of patients who completed the Substance Abuse Treatment Program (SATP) Intensive Outpatient Program (IOP).
Description
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.
Time Frame
28-Day
Title
Rate of abstinence during final week of intensive outpatient therapy (IOP)
Description
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.
Time Frame
21-28 Days
Secondary Outcome Measure Information:
Title
Drug use during outpatient therapy
Description
Proportion of drug-negative urine samples during 4-week outpatient treatment
Time Frame
1-28 Days
Title
Decision-based impulsivity
Description
Severity of delay-discounting behavior in laboratory task
Time Frame
28 Days
Title
Rapid-response impulsivity
Description
Stop signal reaction time (SSRT) in stop-signal computer task
Time Frame
28 Days
Title
Problem-solving ability
Description
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.
Time Frame
28 Days
Title
Depression symptomatology
Description
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.
Time Frame
Pre-treatment baseline and 28 Days
Title
Quality of life as assessed by the Quality of Life Inventory (QoLI) total score.
Description
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.
Time Frame
Pre-treatment baseline and 28 Days
Title
Impulsive personality
Description
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.
Time Frame
Pre-treatment baseline and 28 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James M Bjork, PhD
Organizational Affiliation
Hunter Holmes McGuire VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hunter Holmes McGuire VA Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Neurobehavioral Measurement of Substance Users in Outpatient Treatment Setting

We'll reach out to this number within 24 hrs