Neurobehavioral Measurement of Substance Users in Outpatient Treatment Setting

NCT03662529 | Completed

• 1 other identifier: 02287
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Cocaine Dependence; Cocaine Use Disorder; Opiate Dependence; Opioid-use Disorder; Cannabis Dependence

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (7)

• Drug use during outpatient therapy

  1-28 Days

• Decision-based impulsivity

  28 Days

• Rapid-response impulsivity

  28 Days

• Problem-solving ability

  28 Days

• Depression symptomatology

  Pre-treatment baseline and 28 Days

Study Arms (2)

Mind Freedom Plan therapy sessions

EXPERIMENTAL

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.

Behavioral: Four-Session Mind Freedom Plan

Treatment as usual therapy

ACTIVE COMPARATOR

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.

Behavioral: Treatment as usual therapy

Interventions

Four-Session Mind Freedom Plan BEHAVIORAL

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

Also known as: Mind Freedom Plan

Mind Freedom Plan therapy sessions

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.

Also known as: Treatment as usual

Treatment as usual therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Enrollment in the Substance Abuse Treatment Program - Intensive Outpatient Program
• Currently meets criteria for an Alcohol or Substance Use Disorder per SUD clinic intake

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hunter Holmes Mcguire Veteran Affairs Medical Center: lead
• VA Mental Illness Research, Education and Clinical Centers: collaborator

Study Sites (1)

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, 23249, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders; Opioid-Related Disorders; Marijuana Abuse

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Narcotic-Related Disorders

Study Officials

• James M Bjork, PhD

  Hunter Holmes McGuire VA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neuroscientist

Model Details: 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.

Study Record Dates

• First Submitted: August 17, 2018
• First Posted: September 7, 2018
• Study Start: June 5, 2017
• Primary Completion: January 8, 2018
• Study Completion: February 1, 2018
• Last Updated: September 7, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)