Evaluation of a Motion-Activated Refusal-Skills Training Video Game for Prevention of Substance Use Disorder Relapse

NCT03957798 | Completed

• 1 other identifier: MREZ-001
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

The project proposes to continue the development of an intervention for relapse prevention in the form of a professional quality video game which rewards drug-rejecting physical motions and spoken refusal phrases. Phase I research findings showed that youth in recovery experienced increased low craving levels, strong levels of satisfaction, and interest in attending treatment sessions where the intervention is available - an important outcome since failure to attend treatment is highly correlated with relapse. In Phase II, the investigators propose to modify and expand the prototype based on customer feedback from treatment centers, counselors and patients. The investigators will test the effectiveness of the motion and voice-controlled game in a randomized controlled trial of youths in treatment for opioid use disorder who have access to the game for a month. The investigators will measure the effect of gameplay on successful completion of detoxification/inpatient treatment and rates of linkage to next level of outpatient treatment. The investigators will also measure the effect of gameplay compared to treatment as usual (TAU) during a subsequent episode of outpatient treatment (following inpatient), on rates of treatment attendance, treatment retention, urine drug test results, substance use self-report, treatment alliance, drug craving, and treatment satisfaction.

Conditions

Relapse; Opioid Use; Marijuana Usage

Outcome Measures

Primary Outcomes (2)

• Change in craving

  For cravings, the 5-item Penn Alcohol Craving Scale was included at baseline, discharge, and postdischarge follow-up surveys, but modified to apply to marijuana and opioid use. It assessed the intensity of a participant's cravings (0=none at all to 6=very strong; sum of a maximum total of 30 points).

  baseline, discharge (up to 2 weeks from baseline), 4 week, 8 week

• Change in self-efficacy

  Self-efficacy for refusal of drugs was measured using the Marijuana Resistance Self-Efficacy scale at baseline, discharge, and follow-up surveys. It used a 4-item, 4-point scale (1=very easy to 4=very hard) that asked participants how easy or hard it would be to refuse the drug if offered and explain why they did not want it, why they wanted to avoid the situation in the first place, and why they wanted to leave the situation. It was adapted so that there was a similar version for opioid use. Participants were only asked about the primary drug for which they enrolled in treatment (ie, marijuana or opioids).

  baseline, discharge (up to 2 weeks from baseline), 4 week, 8 week

Secondary Outcomes (2)

• Refusal Skill

  4 week

• Abstinence of drug use

  Baseline, 4 week, 8 week

Other Outcomes (2)

• Counselor Alliance

  discharge (up to 2 weeks from baseline), 4 week, 8 week

• Treatment Rating

  4 week, 8 week

Study Arms (2)

Control (Treatment as Usual)

NO INTERVENTION

TAU consists of inpatient substance abuse treatment, followed by referral to outpatient treatment. For those who live within the outpatient geographic catchment area of the treatment center, patients are subsequently admitted to outpatient levels of care at treatment center. For the non-opioid population (primarily marijuana), this consists of the intensive outpatient program counseling sessions starting at a frequency of 3x/wk, tapering to 1x/wk with clinical progress with 12 wks target length of service. For the opioid population, this consists of a specialty youth opioid program with group and individual counseling, relapse prevention medications treatment, psychiatric assessment and treatment, also starting at a frequency of 3x/wk, tapering to 1x/wk with clinical progress, with indefinite target length of service. For those not within the outpatient geographic catchment area, patients are referred to local continuing care and outpatient levels of care convenient to their homes.

Intervention (Treatment as usual + game)

EXPERIMENTAL

Behavioral: RecoveryWarrior 2.0

Interventions

RecoveryWarrior 2.0 BEHAVIORAL

RecoveryWarrior 2.0 was developed for use with Microsoft Kinect running on a Windows personal computer. All games made use of whole-body motion detection and the same voice-recognition feature. Body motions included a variety of arm, leg, and whole-body movements to physically enact the motions of destroying or evading images of drugs and drug paraphernalia. Voice features consisted of recognition of the refusal phrase "I'm Clean" Players could say or shout "I'm Clean" in order to gain additional strength for their game play avatar. All game art was created in a hyperrealistic, idealized, heroic style.

Intervention (Treatment as usual + game)

Eligibility Criteria

• Age: 15 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• attending the MMTC inpatient program for primarily opioid or marijuana use disorder treatment
• ability to speak English

You may not qualify if:

• presence of a comorbid psychiatric condition that would make participation unsafe (eg, acute suicidality or unstable psychosis)
• pregnancy (because of the physical exertion required to play the game)

Sponsors & Collaborators

• George Washington University: lead
• Maryland Treatment Centers: collaborator

Related Publications (1)

• Abroms LC, Fishman M, Vo H, Chiang SC, Somerville V, Rakhmanov L, Ruggiero M, Greenberg D. A Motion-Activated Video Game for Prevention of Substance Use Disorder Relapse in Youth: Pilot Randomized Controlled Trial. JMIR Serious Games. 2019 May 23;7(2):e11716. doi: 10.2196/11716.

  PMID: 31124471 DERIVED

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel Greenberg, BFA

  Media Rez LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: May 21, 2019
• Study Start: February 5, 2016
• Primary Completion: June 21, 2016
• Study Completion: October 31, 2016
• Last Updated: May 21, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share