Computerized Exercise to Alter Stimulant Approach Responses
CEASAR
CEASAR (Computerized Exercise to Alter Stimulant Approach Responses) - Piloting a Novel Intervention to Improve Outcomes in Individuals Suffering From Cocaine or Methamphetamine Use Disorder: A Randomized Controlled Study
1 other identifier
interventional
60
1 country
1
Brief Summary
The purpose of this study is to evaluate the Computerized Exercise to Alter Stimulant Approach Responses (CEASAR), a novel stimulant use cessation intervention, for clients currently enrolled in a treatment centre for mental health and addiction. The investigators plan to conduct a randomized, single-blind controlled trial involving inpatients presenting with concurrent disorders to test the impact of this novel computerized intervention. This pilot study will be conducted at the Burnaby Centre for Mental Health and Addiction (BCMHA) in Burnaby, BC, Canada.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2018
Longer than P75 for not_applicable
1 active site
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
June 11, 2018
CompletedFirst Submitted
Initial submission to the registry
March 27, 2019
CompletedFirst Posted
Study publicly available on registry
April 4, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2022
CompletedJune 21, 2021
June 1, 2021
3.8 years
March 27, 2019
June 18, 2021
Conditions
Outcome Measures
Primary Outcomes (3)
Changes in craving as assessed by the Stimulant Craving Questionnaire-Brief (SCQ-B)
Changes in craving will be assessed at baseline before the intervention, and at 4, 8, and 12 weeks after. It will be assessed by the Stimulant Craving Questionnaire-Brief (SCQ-B), which uses a 7-item scale (0 = Strongly Disagree, 6 = Strongly Agree) that can produce a composite score between 0 and 6. On this scale, lower scores indicate less craving which is considered a better outcome. Higher scores indicate more craving which is considered a worse outcome.
Baseline, 4 weeks, 8 weeks, 12 weeks
Change in Behavioural association as assessed by the Behaviour Association Scale
The Behaviour Association Scale measures association of substance use with different situations. Subscale 1, Word Associations: participants list the first word or phrase they associate with a given word. There are 13 word prompts, so the scale runs from 0 (no prompts associated with substance use) to 13 (all prompts associated with substance use). A low score is considered a better outcome because it means fewer situations are associated with substance use. Subscale 2, Behavioral Associations: operates the same way, except that there are 20 prompts listed so the scale runs from 0-20. These subscales are each measured on 2 dimensions, for a total of 4 dimensions to the scale. Dimension A: Each subscale is self-coded by the participant, where the participant determines if their response is substance-use related. Dimension B: Each subscale is researcher-coded, where 2 coders determine whether or not the response is unambiguously related to substance use.
Baseline, 4 weeks, 8 weeks, 12 weeks
Relapse to use as assessed by weekly self-reports and urine drug screens
Number of relapse days between week 2 and week 12 will be assessed.
Between week 2 and week 12
Study Arms (2)
Active CEASAR Intervention
ACTIVE COMPARATORParticipants will be given the active CEASAR intervention where they will be trained to "avoid" cues associated with stimulant use and approach healthy cues based on the orientation of the images presented. Individuals will be asked to approach (pull in) portrait images and avoid (push away) landscape images. In the active condition, pushed pictures (landscape orientation) will exclusively be stimulant-use related pictures. Conversely, healthy images will be in the portrait orientation which will be pulled in.
Placebo CEASAR
PLACEBO COMPARATORIn the control condition, stimulant use-related pictures will be randomized and equally divided into push (landscape) and pull (portrait) conditions.
Interventions
Healthy and stimulant-use related pictures will be presented on a computer screen. Using a joystick, participants will be trained to pull in pictures that are presented in portrait orientation, and push those presented horizontally. In the active experimental condition, pushed pictures will exclusively be stimulant-related pictures.
In the control condition, stimulant cues and healthy cues will be randomized and stimulant use-related pictures will be equally divided into push and pull conditions.
Eligibility Criteria
You may qualify if:
- In-patient of the Burnaby Centre of Mental Health \& Addiction
- years of age or older
- Individuals with a current stimulant use disorder (cocaine, crack cocaine, amphetamine, methamphetamine, crystal meth), active before intake at BCMHA (as assessed by the MINI)
- Proficiency to read and write English and competent to provide consent
You may not qualify if:
- Individuals not stabilized enough to allow for regular participation in the intervention (determined by treating psychiatrist)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Burnaby Centre for Mental Health and Addiction
Vancouver, British Columbia, V5G 3H4, Canada
Related Publications (2)
Wiers RW, Eberl C, Rinck M, Becker ES, Lindenmeyer J. Retraining automatic action tendencies changes alcoholic patients' approach bias for alcohol and improves treatment outcome. Psychol Sci. 2011 Apr;22(4):490-7. doi: 10.1177/0956797611400615. Epub 2011 Mar 9.
PMID: 21389338BACKGROUNDWiers RW, Rinck M, Kordts R, Houben K, Strack F. Retraining automatic action-tendencies to approach alcohol in hazardous drinkers. Addiction. 2010 Feb;105(2):279-87. doi: 10.1111/j.1360-0443.2009.02775.x.
PMID: 20078486BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christian Schutz, MD PhD MPH
University of British Columbia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
March 27, 2019
First Posted
April 4, 2019
Study Start
June 11, 2018
Primary Completion
March 31, 2022
Study Completion
March 31, 2022
Last Updated
June 21, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share