Contingency Management for Psychosis

Overseen By Charlene Osei-Afrifa

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Douglas Mental Health University Institute

Must not be taking: Psychotropic medication

Disqualifiers: SUD, Suicidal ideation, Head injury, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 10

134 Participants Needed

Trial Summary

What is the purpose of this trial?

Cognitive impairment is well established in people with psychosis and is associated with cannabis use. The current study will investigate the neurobiological basis of cognitive change associated with 28-days of cannabis abstinence in people with psychosis and non-psychiatric controls with cannabis use. Participants will be randomized to a cannabis abstinent group or a non-abstinent control group and will undergo magnetic resonance imaging at baseline and following 28-days of abstinence. This study will help characterize the neuropathophysiological processes underlying cognitive dysfunction associated with cannabis use and its recovery which may guide the development of novel interventions for problematic cannabis use.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires that psychosis patients be on a stable dose of their medication for at least two months. Non-psychiatric controls cannot be taking psychotropic medication.

What data supports the effectiveness of the treatment Contingency Management for Psychosis?

Research shows that using rewards to encourage positive behavior, known as Contingency Management, has been effective in improving medication adherence in patients with psychotic disorders and increasing engagement in mental health treatment. Additionally, it has been successful in promoting abstinence in substance use disorders, suggesting its potential effectiveness in treating psychosis. ^{1 2 3 4 5}

Is Contingency Management safe for humans?

The research does not provide specific safety data for Contingency Management, but it has been used in various studies without reported safety concerns, suggesting it is generally considered safe for human use. ^{1 3 6 7 8}

How does contingency management treatment for psychosis differ from other treatments?

Contingency management is unique because it uses financial incentives or rewards to encourage patients to engage in their mental health treatment, which is different from traditional therapies that do not typically involve such motivational strategies. ^{1 2 4 9 10}

Research Team

Rachel Rabin, Ph. D.

Principal Investigator

Douglas Mental Health University Institute

Eligibility Criteria

This trial is for adults who use cannabis heavily and either have psychosis or no psychiatric conditions. Participants must speak English or French, have an IQ over 75, and be stable on medications if they have psychosis. They can't join if they use other psychoactive substances, are suicidal, pregnant, need hospitalization for medical issues, take psychotropic meds (except those with psychosis), or have MRI contraindications.

Inclusion Criteria

Clinically stable (as measured by the PANSS-6, total score <30) (psychosis patient arm only)

I have been on a stable dose of my psychosis medication for at least two months.

Have a Full-Scale IQ ≥ 75

Exclusion Criteria

Positive urine screen for psychoactive substances other than cannabis, nicotine, or caffeine

Being pregnant

I am currently taking medication for my mental health.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo structural and functional MRI while completing a memory task

1 day

1 visit (in-person)

Treatment/Intervention

Participants are randomized to either a cannabis abstinent group or a non-abstinent control group for 28 days

4 weeks

8 visits (in-person) for urine sample collection

Follow-up

Participants undergo follow-up MRI to assess changes in brain activity and morphology after 28 days

1 day

1 visit (in-person)

Treatment Details

Interventions

• Contingency Management

Trial Overview The study examines how stopping cannabis affects brain function in people with and without psychosis over 28 days. It involves random assignment to a group that quits using cannabis or a control group that continues as usual. Brain changes will be monitored using MRI scans before and after the abstinence period.

Participant Groups

Group I: Psychosis patients with cannabis use (Abstinent) Experimental Treatment 1 Intervention

Psychosis patients with cannabis use will receive contingency management to encourage cannabis abstinence for 28 days

Group II: Non-Psychiatric controls with cannabis use (Abstinent) Experimental Treatment 1 Intervention

Non-Psychiatric controls with cannabis use will receive contingency management to encourage cannabis abstinence for 28 days

Group III: Psychosis patients with cannabis use (Non-abstinent) Active Control 1 Intervention

Psychosis Patients with cannabis use who will continue to use cannabis as usual

Group IV: Non-Psychiatric controls with cannabis use (Non-abstinent) Active Control 1 Intervention

Non-Psychiatric Controls with cannabis use will continue to use cannabis as usual

Group V: Non-Psychiatric Controls without cannabis use Active Control 1 Intervention

Non-Psychiatric controls without cannabis use

Who Is Running the Clinical Trial?

Douglas Mental Health University Institute

Lead Sponsor

Trials

31

Recruited

2,800+

Findings from Research

Offering financial incentives significantly boosts engagement in mental health treatment, particularly for substance use disorders, with medium to large effect sizes for treatment attendance (Hedges' g = 0.49) and medication adherence (Hedges' g = 0.95).

The study highlights the need for further research on the effectiveness of financial incentives for a broader range of mental health disorders and emphasizes the importance of addressing ethical and systemic barriers to implementing these strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do financial incentives increase mental health treatment engagement? A meta-analysis. Khazanov, GK., Morris, PE., Beed, A., et al.[2023]

A survey of 214 substance use treatment providers revealed that while many clinics are using reward programs, they often do not follow effective practices recommended by research, such as providing higher reward amounts or immediate reinforcement.

Providers with more extensive training in contingency management (CM) were more likely to implement effective strategies, suggesting that better training could improve the quality of reward-based interventions in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining implementation of contingency management in real-world settings. Rash, CJ., Alessi, SM., Zajac, K.[2021]

The study involves 168 outpatients with psychotic disorders, randomly assigned to receive financial rewards for medication adherence or standard treatment, aiming to improve acceptance of antipsychotic depot medication over a 12-month period.

The primary goal is to evaluate the effectiveness of the 'Money for Medication' (M4M) intervention in increasing the percentage of accepted medication doses, while also assessing its impact on psychosocial functioning and overall patient wellbeing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Money for medication: a randomized controlled study on the effectiveness of financial incentives to improve medication adherence in patients with psychotic disorders. Noordraven, EL., Audier, CH., Staring, AB., et al.[2018]

In a study involving 34 individuals with Cocaine Use Disorder, larger fixed incentives for providing negative urine samples led to faster and more effective abstinence compared to smaller incentives.

The type of incentive structure (escalating and resetting vs. fixed) did not significantly impact the overall effectiveness, suggesting that the magnitude of the incentive is more crucial for promoting abstinence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A preliminary investigation of schedule parameters on cocaine abstinence in contingency management. Regnier, SD., Strickland, JC., Stoops, WW.[2023]

Prize-based abstinence incentives combined with standard treatment did not show significant differences in effectiveness for patients with varying treatment histories, indicating that the incentives may be equally beneficial regardless of prior treatment experience.

The study involved treatment-seeking outpatients and assessed outcomes like the longest period of abstinence and negative urine drug screens, suggesting that these incentives can be a consistent motivational tool across diverse patient backgrounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of motivational incentives in stimulant abusing outpatients with different treatment histories. Killeen, T., Carter, R., Copersino, M., et al.[2019]

In a study involving 551 participants with recent psychosis, the use of contingency management (CM) with incentives for cannabis abstinence did not significantly improve the time to acute psychiatric care compared to a control group receiving psychoeducation only.

Although the CM group showed a slightly lower median time to psychiatric admission (196 days) compared to the control group (245 days), the difference was not statistically significant, indicating that CM may not be an effective intervention for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and cost-effectiveness of contingency management for cannabis use in early psychosis: the CIRCLE randomised clinical trial. Sheridan Rains, L., Marston, L., Hinton, M., et al.[2021]

The proposed funding model for early interventions in psychosis, like the RAISE study, includes a per-case payment that encourages patient engagement, which is crucial for effective treatment.

This model also incorporates a per-service payment for clinical costs and an outcome-based payment that rewards providers for achieving specific treatment milestones, promoting better care for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paying for Early Interventions in Psychoses: A Three-Part Model. Frank, RG., Glied, SA., McGuire, TG.[2015]

In a study of 255 substance users undergoing outpatient treatment, participants who were drug-free at the start (baseline negative) earned significantly more in contingency management (CM) incentives compared to those who were using drugs (baseline positive), with median prizes of $237 versus $44, respectively.

The findings suggest that tailoring CM interventions based on a participant's drug use status at treatment entry could enhance the effectiveness of abstinence-focused programs, as the majority of incentive expenditures were directed towards those who were already abstinent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contingency Management Abstinence Incentives: Cost and Implications for Treatment Tailoring. Cunningham, C., Stitzer, M., Campbell, AN., et al.[2019]

In a study involving 142 outpatients with cocaine or heroin dependence, both voucher and prize-based contingency management (CM) interventions led to longer treatment retention and greater durations of confirmed abstinence compared to standard treatment.

While there were no significant differences in abstinence rates at 6- and 9-month follow-ups, the duration of abstinence achieved during treatment was the strongest predictor of continued abstinence after treatment ended.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vouchers versus prizes: contingency management treatment of substance abusers in community settings. Petry, NM., Alessi, SM., Marx, J., et al.[2016]

A contingency management approach successfully helped a 52-year-old male psychiatric patient control his elevated urine sugar levels by incentivizing him to adhere to a low sugar diet, as evidenced by a ten-day baseline of poor dietary compliance.

Six months after the intervention, the patient maintained improved urine sugar levels, demonstrating the long-term effectiveness of the behavioral modification strategy employed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contingency management of food misbehavior in a psychiatric patient with diabetes. Duvinsky, JD., Jacobs, HE., Foy, DW.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Do financial incentives increase mental health treatment engagement? A meta-analysis. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Examining implementation of contingency management in real-world settings. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Money for medication: a randomized controlled study on the effectiveness of financial incentives to improve medication adherence in patients with psychotic disorders. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

A preliminary investigation of schedule parameters on cocaine abstinence in contingency management. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Effectiveness of motivational incentives in stimulant abusing outpatients with different treatment histories. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Clinical and cost-effectiveness of contingency management for cannabis use in early psychosis: the CIRCLE randomised clinical trial. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Paying for Early Interventions in Psychoses: A Three-Part Model. [2015]

8. United States pubmed.ncbi.nlm.nih.gov

Contingency Management Abstinence Incentives: Cost and Implications for Treatment Tailoring. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Vouchers versus prizes: contingency management treatment of substance abusers in community settings. [2016]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Contingency management of food misbehavior in a psychiatric patient with diabetes. [2019]