Neurobehavioral Measurement of Substance Users in Outpatient Treatment Setting

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-05

Study Completion Date

2018-02-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mind Freedom Plan therapy sessions

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.

Group Type EXPERIMENTAL

Four-Session Mind Freedom Plan

Intervention Type BEHAVIORAL

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

Treatment as usual therapy

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.

Group Type ACTIVE_COMPARATOR

Treatment as usual therapy

Intervention Type 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.

Interventions

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Four-Session Mind Freedom Plan

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

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Mind Freedom Plan Treatment as usual

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No