An Electronic Intervention to Reduce Cannabis Among Young Adults in Psychiatric Care
Primary Purpose
Cannabis Use, Psychiatric Disorder
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
eToke + TPsy
Sponsored by
About this trial
This is an interventional prevention trial for Cannabis Use
Eligibility Criteria
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
Sites / Locations
- Rhode Island HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
eToke + TPsy
Arm Description
All participants will receive the intervention (eToke+TPsy). The intervention consists of eToke (a brief computerized intervention that uses motivational enhancement therapy to improve readiness to decrease cannabis use and increase motivation to engage in substance use treatment) AND 6-8 interactive text messages regarding cannabis use reduction over 4 weeks . Text messages will contain written content, and queries, as well as links to publicly available websites and YouTube videos.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT04174963
First Posted
November 4, 2019
Last Updated
October 19, 2022
Sponsor
Rhode Island Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04174963
Brief Title
An Electronic Intervention to Reduce Cannabis Among Young Adults in Psychiatric Care
Official Title
An Electronic Intervention to Reduce Cannabis Among Young Adults in Psychiatric Care
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rhode Island Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
Young adults 18-28 years old have the highest prevalence rates of cannabis use. Unfortunately, the biological consequences of cannabis use are more severe compared to older adults. These specific biological consequences are due to the negative effect cannabis use has on neurological maturation permanently impacting motivation, impulsivity, and future addictive behavior. The neurological effects of cannabis use are most disruptive to young adults living with psychiatric illness. In the Young Adult Behavioral Health Program at Rhode Island Hospital, 68% of patient's ages 18-28 who are in treatment for psychiatric disorders have used cannabis, and of those that have used 24% use cannabis daily or weekly. These high rates of cannabis use result in deleterious consequences, including developing more severe psychopathology, increased rates of psychosis, impairments in educational achievement and occupational obtainment, poorer treatment outcomes, poorer adherence to treatment, and increased treatment costs. Motivational Enhancement Therapy (MET) is an efficacious strategy for improving readiness to decrease cannabis use and increase motivation to engage in substance use treatment. The MET program entitled eToke (also known as E-Check-Up to Go), is a popular, frequently used, and previously investigated brief computerized intervention with efficacy in improving readiness for change among college students. In this study, the investigators propose to develop a text messaging intervention that will accompany eToke and will be tailored to young adults with psychiatric illness with cannabis use disorders. This intervention will be called e-Toke+TPsy. The text messages used in this intervention will contain information about the deleterious consequences of cannabis use, motivational material about the specific risks of cannabis use for young adults in psychiatric treatment. Texts will also contain behavioral skill building exercises to help reduce the frequency of cannabis use. The material for the text messages will be developed with input from young adults receiving psychiatric care at the Young Adult Behavioral Health Program. Text messages will also be informed by the Information, Motivation, and Behavioral Skills Theory of learning (IMB Theory).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Use, Psychiatric Disorder
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
eToke + TPsy
Arm Type
Experimental
Arm Description
All participants will receive the intervention (eToke+TPsy). The intervention consists of eToke (a brief computerized intervention that uses motivational enhancement therapy to improve readiness to decrease cannabis use and increase motivation to engage in substance use treatment) AND 6-8 interactive text messages regarding cannabis use reduction over 4 weeks . Text messages will contain written content, and queries, as well as links to publicly available websites and YouTube videos.
Intervention Type
Behavioral
Intervention Name(s)
eToke + TPsy
Intervention Description
Combination of brief computerized intervention (eToke) with Information-Motivation-Behavior based text messages tailored to young adults in psychiatric treatment
Primary Outcome Measure Information:
Title
Change in Self-reported Frequency of Cannabis Use
Description
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.
Time Frame
Assessed at weeks 2, 4, 5, 6, 7, 8, 9, 10, and 11
Title
Change in Self-reported Motivation to Reduce Cannabis Use (SOCRATES)
Description
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.
Time Frame
Assessed at baseline and 12 weeks
Title
Change in Self-reported Motivation to Reduce Cannabis Use (Readiness Ruler)
Description
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.
Time Frame
Assessed at baseline and 12 weeks
Title
Change in Self-reported Motivation to Reduce Cannabis Use (DBI)
Description
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.
Time Frame
Assessed at baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Change in Self-reported Psychiatric Symptoms
Description
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.
Time Frame
Assessed at baseline and 12 weeks
Title
Change in Self-reported Self-efficacy to Reduce Cannabis Use (SCQ-8)
Description
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.
Time Frame
Assessed at baseline and 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
28 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Whiteley, MD
Phone
(401)-455-6375
Email
laura_whiteley@brown.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Larry Brown, MD
Phone
(401)-793-8808
Email
lkbrown@lifespan.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Whiteley, MD
Organizational Affiliation
Rhode Island Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Larry Brown, MD
Organizational Affiliation
Rhode Island Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura B Whiteley, MD
Phone
401-793-8808
Email
lwhiteley@lifespan.org
12. IPD Sharing Statement
Citations:
PubMed Identifier
23036216
Citation
Elliott JC, Carey KB. Correcting exaggerated marijuana use norms among college abstainers: a preliminary test of a preventive intervention. J Stud Alcohol Drugs. 2012 Nov;73(6):976-80. doi: 10.15288/jsad.2012.73.976.
Results Reference
background
Citation
Miller WR, Tonigan JS. Assessing drinkers' motivation for change: The Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES). Psychology of Addictive Behaviors 10(20): 81-89, 1996.
Results Reference
background
PubMed Identifier
9183504
Citation
Migneault JP, Pallonen UE, Velicer WF. Decisional balance and stage of change for adolescent drinking. Addict Behav. 1997 May-Jun;22(3):339-51. doi: 10.1016/s0306-4603(96)00252-3.
Results Reference
background
PubMed Identifier
6622612
Citation
Derogatis LR, Melisaratos N. The Brief Symptom Inventory: an introductory report. Psychol Med. 1983 Aug;13(3):595-605.
Results Reference
background
PubMed Identifier
8883482
Citation
Kirisci L, Moss HB, Tarter RE. Psychometric evaluation of the Situational Confidence Questionnaire in adolescents: fitting a graded item response model. Addict Behav. 1996 May-Jun;21(3):303-17. doi: 10.1016/0306-4603(95)00060-7.
Results Reference
background
PubMed Identifier
12199834
Citation
WHO ASSIST Working Group. The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST): development, reliability and feasibility. Addiction. 2002 Sep;97(9):1183-94. doi: 10.1046/j.1360-0443.2002.00185.x.
Results Reference
background
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An Electronic Intervention to Reduce Cannabis Among Young Adults in Psychiatric Care
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