Cannabis Use Clinical Trial
Official title:
An Electronic Intervention to Reduce Cannabis Among Young Adults in Psychiatric Care
NCT number | NCT04174963 |
Other study ID # | 1445964 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | November 1, 2019 |
Est. completion date | May 24, 2022 |
Verified date | November 2023 |
Source | Rhode Island Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Cannabis use disorders are common among young adults in psychiatric treatment. Unfortunately, cannabis use can result in deleterious consequences for those in treatment, including developing more severe psychopathology and poorer treatment outcomes. Brief, electronic interventions for cannabis use have been developed for young adults. An example of a frequently used brief electronic intervention for cannabis users is e-Toke. e-Toke can be completed on a computer, tablet or phone, and has been shown to improve motivation to engage in substance use treatment among college students. However, e-Toke is less useful in decreasing the actual frequency of cannabis use. Additionally, e-toke is not tailored to young adults in psychiatric treatment. In this study, the investigators will develop and test a text messaging intervention that can be easily added to the popular computerized intervention e-Toke. The research staff hope the intervention will improve motivation to decrease cannabis use, and decrease the frequency of cannabis use, among young adults in psychiatric outpatient treatment. The text messages will be developed by, and tailored to, young adults in psychiatric treatment and texts will address motivations and barriers to reducing cannabis use in the context of psychiatric disorders. If the text message intervention is found to be an effective addition to e-Toke, this approach can be tested in a larger study, and then disseminated to other young adults in psychiatric treatment.
Status | Terminated |
Enrollment | 12 |
Est. completion date | May 24, 2022 |
Est. primary completion date | May 24, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 28 Years |
Eligibility | Inclusion Criteria: - 18 - 28 years of age - Report using cannabis 2 or more times per week - English speaking - Have a telephone that can receive text-messages - Receive psychiatric treatment in the Young Adult Behavioral Health Program or Partial Program at Rhode Island Hospital. - Be at high risk for psychosis according to mental health guidelines Exclusion Criteria: - Psychiatric symptoms severe enough to preclude meaningful consent or participation, as determined by the treatment psychiatrist and research team - Current clinical diagnosis of mental retardation or pervasive developmental disorder |
Country | Name | City | State |
---|---|---|---|
United States | Rhode Island Hospital | Providence | Rhode Island |
Lead Sponsor | Collaborator |
---|---|
Rhode Island Hospital |
United States,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Self-reported Frequency of Cannabis Use | This self-report will be obtained using an abbreviated version of the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) nine times throughout the duration of the study. The abbreviated ASSIST will be administered at weeks 2, 4, 5, 6, 7, 8, 9, 10, and 11 of the study. | Assessed at weeks 2, 4, 5, 6, 7, 8, 9, 10, and 11 | |
Primary | Change in Self-reported Motivation to Reduce Cannabis Use (SOCRATES) | Motivation to change substance use will be assessed using the Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES) adapted for cannabis use (19-item questionnaires that assess recognition, ambivalence, and taking steps). Change will be assessed from baseline to 12-weeks follow-up. | Assessed at baseline and 12 weeks | |
Primary | Change in Self-reported Motivation to Reduce Cannabis Use (Readiness Ruler) | Motivation to change substance use will be assessed using the Readiness Ruler (rates degree of readiness to cut down ranging from 1 to 10 for twelve different substance categories). Change will be assessed from baseline to 12-weeks follow-up. | Assessed at baseline and 12 weeks | |
Primary | Change in Self-reported Motivation to Reduce Cannabis Use (DBI) | Motivation to change substance use will be assessed using the Decisional Balance Inventory (16-item measure of the pros and cons of substance use). Change will be assessed from baseline to 12-weeks follow-up. | Assessed at baseline and 12 weeks | |
Secondary | Change in Self-reported Psychiatric Symptoms | Mental health issues will be assessed by the Brief Symptom Inventory (BSI-18), which yields primary symptom scales and global indices and has norms for adolescents and adults. The reliability, validity, and utility of the BSI instrument have been tested in more than 400 research studies. Internal consistency for the sub-scales (dimensions) range from .71 to .85. Each item will be reported on a scale of 0 to 4, with higher scores indicating greater mental health symptoms. Change will be assessed from baseline to 12-weeks follow-up. | Assessed at baseline and 12 weeks | |
Secondary | Change in Self-reported Self-efficacy to Reduce Cannabis Use (SCQ-8) | Self-efficacy will be assessed with the Situational Confidence Questionnaire (SCQ-8), an 8-item measure that assesses an individual's confidence in being able to resist the urge to use a given substance across different situations. The SCQ has been demonstrated reliable and valid. Each item is reported on a scale of 0 to 100, with higher scores indicating greater self-efficacy to resist using cannabis. Change will be assessed from baseline to 12-weeks follow-up. | Assessed at baseline and 12 weeks |
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