Contingency Management for PTSD
(FOCUS Trial)
Recruiting in Palo Alto (17 mi)
Overseen byJean C Beckham, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: VA Office of Research and Development
Disqualifiers: Bipolar, Schizophrenia, Imprisonment, others
No Placebo Group
Trial Summary
What is the purpose of this trial?Posttraumatic stress disorder (PTSD) is a disabling psychiatric disorder that affects 20%-30% of U.S. Veterans. PTSD is strongly associated with increased risk for substance abuse comorbidity, including cannabis use disorder. Multiple states now include PTSD as a condition for which patients can be legally prescribed medical marijuana, despite the fact that there has not been a single large-scale randomized clinical trial demonstrating the efficacy of cannabis to treat PTSD to date. The overall objective of the current proposal is to study the impact of reduced cannabis use on functioning among Veterans with PTSD. The investigators will evaluate the relationship between cannabis use and daily functioning among cannabis users and heavy cannabis users. The central hypothesis is that reductions in cannabis use will lead to positive changes in the functional outcomes of Veterans. The rationale for this research is that it will provide the first and only real-time data concerning the impact of reduced cannabis use on daily functioning among Veterans with PTSD.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you've had a change in your psychiatric medication regimen in the past month or expect a change during the study.
Is Contingency Management safe for humans?
Contingency Management (CM) has been used safely in various settings, particularly for treating substance use disorders. It involves providing incentives to encourage positive behaviors, and there are no reports of harmful effects from its use in the studies reviewed.
12345How is the treatment Contingency Management (CM) unique for PTSD?
Contingency Management (CM) is unique because it uses tangible rewards to encourage positive behavior changes, which is different from traditional PTSD treatments that often focus on talk therapy or medication. This approach is based on behavioral principles and has been effective in treating substance use disorders, suggesting it may offer a novel way to support behavior change in PTSD patients.
16789Eligibility Criteria
This trial is for U.S. Veterans with PTSD who frequently use cannabis (13+ days in the past month) and can communicate in English. It's not open to those who've changed psychiatric meds recently, are getting non-study treatment for Cannabis Use Disorder, have been hospitalized or imprisoned, or have bipolar disorder, schizophrenia, or a substance use disorder other than cannabis.Inclusion Criteria
I have been diagnosed with PTSD.
Veteran status
Ability to speak and write fluent English
+1 more
Exclusion Criteria
I have been hospitalized for mental health reasons.
Become imprisoned
Are receiving non-study CUD treatment
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo mobile contingency management (CM) to promote reductions in cannabis use
6 weeks
Baseline and post-treatment assessments
Follow-up
Participants are monitored for changes in quality of life, functional impairment, cannabis use, and psychiatric distress
4 weeks
Participant Groups
The FOCUS trial investigates whether reducing cannabis use improves daily functioning in Veterans with PTSD. The study uses Contingency Management (CM), which rewards individuals for meeting goals like reduced substance use.
1Treatment groups
Experimental Treatment
Group I: Contingency Management (CM)Experimental Treatment1 Intervention
Mobile contingency management (CM) will be used to promote reductions in cannabis use among Veterans with PTSD who are heavy cannabis users. CM is an intensive behavioral therapy in which participants are paid to reduce substance use.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Durham VA Medical Center, Durham, NCDurham, NC
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Who Is Running the Clinical Trial?
VA Office of Research and DevelopmentLead Sponsor
References
Improving substance misuse outcomes in contingency management treatment with adjunctive formal psychotherapy: a systematic review and meta-analysis. [2021]Contingency management (CM) is a treatment for substance misuse that involves the provision of incentives. This review examines the hypothesis that adding another formal psychotherapy, such as cognitive-behavioural therapy (CBT) or motivational enhancement therapy (MET), to CM improves substance use outcomes at both treatment end and at post-treatment follow-up compared with CM only.
Implementation of Contingency Management at a Large VA Addiction Treatment Center. [2018]Contingency management (CM) is an evidence-based intervention that reinforces target behaviors of patients, such as abstinence from substance use. This column discusses the experiences and lessons learned at a large U.S. Department of Veterans Affairs Addiction Treatment Center during implementation of CM as part of the VA's national rollout. Challenges are discussed related to staff reception and limited initial referrals, identifying a drug testing method and staff confidence in that method, training requirements, and financial resources needed. Local innovations and CM expansion since 2012 are also reviewed.
An effectiveness trial of contingency management in a felony preadjudication drug court. [2021]This study evaluated a contingency management (CM) program in a drug court. Gift certificates for compliance were delivered at 4- to 6-week intervals (total value = $390.00). Participants in one condition earned gift certificates that escalated by $5.00 increments. Participants in a second condition began earning higher magnitude gift certificates, and the density of reinforcement was gradually decreased. No main effects of CM were detected, which appears to be attributable to a ceiling effect from the intensive contingencies already delivered in the drug court and the low density of reinforcement. Preplanned interaction analyses suggested that participants with more serious criminal backgrounds might have performed better in the CM conditions. This suggests that CM programs may be best suited for more incorrigible drug offenders.
Implementing an evidence-based prize contingency management protocol for stimulant use. [2023]Contingency management (CM) is an efficacious treatment for stimulant use disorders. Support materials for the clinical delivery of prize-based CM are widely accessible, but few resources are available to support design and preparation for CM implementation. This guide aims to fill that gap.
Contingency management: utility in the treatment of drug abuse disorders. [2019]Contingency management (CM) is a strategy that uses positive reinforcement to improve the clinical outcomes of substance abusers in treatment, especially sustained abstinence from drugs of abuse. Further, CM has been adopted to improve methodology and interpretation of outcomes in clinical trials testing new pharmacotherapies and to improve adherence to efficacious medications in substance abuse patients. Thus, CM has proven to be widely useful as a direct therapeutic intervention and as a tool in treatment development.
A randomized trial of contingency management delivered by community therapists. [2023]Contingency management (CM) is an evidence-based treatment, but few clinicians deliver this intervention in community-based settings.
Budget Impact Tool for Implementing Contingency Management for Co-occurring Alcohol Use Disorders and Serious Mental Illness. [2023]Contingency management (CM) is a behavioral intervention in which tangible incentives are provided to patients when they achieve a desired behavior (e.g., reducing or abstaining from alcohol use). The authors sought to describe the resource requirements and associated costs of various CM versions (usual, high magnitude, and shaping) tailored to a high-risk population with co-occurring serious mental illness and severe alcohol use disorder.
Motivation and Contingency Management Treatments for Substance Use Disorders. [2016]Contingency management (CM) is a highly efficacious psychosocial treatment for substance use disorders based on the principles of behavioral analysis. CM involves delivering a tangible positive reinforcer following objective evidence of submission of a drug-negative urine sample. Although CM interventions primarily involve applying extrinsic rewards, a patient's intrinsic motivation to change substance use behavior may also be impacted by CM. This chapter provides an introduction to CM interventions for substance use disorders and examines the impact of CM on intrinsic motivation . It also addresses applications of this intervention to other conditions and patient populations.
A randomized study of contingency management in cocaine-dependent patients with severe and persistent mental health disorders. [2021]Contingency management (CM) is efficacious for reducing drug use, but it has rarely been applied to patients with severe and persistent mental health problems. This study evaluated the efficacy of CM for reducing cocaine use in psychiatric patients treated at a community mental health center.