NCT04174963

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2019

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

November 4, 2019

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 22, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 24, 2022

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

2.6 years

First QC Date

November 4, 2019

Last Update Submit

November 14, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (2)

  • Change in Self-reported Psychiatric Symptoms

    Assessed at baseline and 12 weeks

  • Change in Self-reported Self-efficacy to Reduce Cannabis Use (SCQ-8)

    Assessed at baseline and 12 weeks

Study Arms (1)

eToke + TPsy

EXPERIMENTAL

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.

Behavioral: eToke + TPsy

Interventions

eToke + TPsyBEHAVIORAL

Combination of brief computerized intervention (eToke) with Information-Motivation-Behavior based text messages tailored to young adults in psychiatric treatment

eToke + TPsy

Eligibility Criteria

Age18 Years - 28 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Related Publications (6)

  • 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.

    PMID: 23036216BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 9183504BACKGROUND
  • Derogatis LR, Melisaratos N. The Brief Symptom Inventory: an introductory report. Psychol Med. 1983 Aug;13(3):595-605.

    PMID: 6622612BACKGROUND
  • 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.

    PMID: 8883482BACKGROUND
  • 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.

    PMID: 12199834BACKGROUND

MeSH Terms

Conditions

Mental Disorders

Study Officials

  • Laura Whiteley, MD

    Rhode Island Hospital

    PRINCIPAL INVESTIGATOR
  • Larry Brown, MD

    Rhode Island Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 4, 2019

First Posted

November 22, 2019

Study Start

November 1, 2019

Primary Completion

May 24, 2022

Study Completion

May 24, 2022

Last Updated

November 18, 2023

Record last verified: 2023-11

Locations