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OpenTrials
Completed

NCT Number: NCT03957798

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

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.

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Key information

Age range

15 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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)

Treatment and study plan

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.

Primary outcomes

  1. Change in craving

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

    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).

  2. Change in self-efficacy

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

    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).

Secondary outcomes

  1. Refusal Skill

    Time frame: 4 week

    Refusal skills were measured by asking participants if they agreed that they would use the phrase "I'm Clean" to refuse drugs (1=not agree to 5=highly agree), if they had used the phrase "I'm Clean" since discharge to refuse drugs, and if the phrase "I'm Clean" still rings in their head (not at all, less than once per week, a few times a week, or more often).

  2. Abstinence of drug use

    Time frame: Baseline, 4 week, 8 week

    Participants were asked about the primary drug that they were in treatment for. Opioid and marijuana use at follow-up was ascertained by self-report of any use in the past 7 and 30 days.

Other outcomes

  1. Counselor Alliance

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

    Treatment rating was measured in three ways. First, it was measured with the Counselor Alliance Scale, which was taken from the Working Alliance Inventory, and used to measure treatment progress with the counselor at discharge, 4 weeks, and 8 weeks. The Counselor Alliance Scale uses 7-items and 7-points to measure how well participants believe counselors are working with them to improve their situation (1=never to 7=always).

  2. Treatment Rating

    Time frame: 4 week, 8 week

    The treatment rating was also measured by asking participants about their satisfaction with inpatient care at the time of discharge and satisfaction with outpatient care at the 4-week and 8-week follow-up surveys.

Sponsors and collaborators

Lead sponsor

George Washington University

Other

Collaborators

  • Maryland Treatment Centers

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 21, 2019
Registry last updated
May 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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