Back to resultsEfficacy of Cognitive Bias Modification in Residential Treatment for Addiction
Primary Purpose
Substance Dependence
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cognitive Bias Modification
Sponsored by
About this trial
This is an interventional treatment trial for Substance Dependence focused on measuring cognitive bias modification, interpretation bias, suicidal ideation, depression
Eligibility Criteria
Inclusion Criteria:
- Exhibit moderate suicide risk or greater
- Be enrolled in the Addictions Services inpatient program
- Fluent in reading English
- Capacity to give informed consent
Exclusion Criteria:
- A lifetime diagnosis of a psychotic or bipolar disorder
- Significant neurological disorder or psychical illness likely to interfere with participation
- Psychotropic medication changes within the past two weeks
Sites / Locations
- Centre for Addiction and Mental Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Cognitive Bias Modification
Assessment-Only Control
Arm Description
64 training paragraphs, approximately 10-20 seconds each, digitally recorded and presented stereophonically through headphones, delivered over the course of one week.
No training will be provided.
Outcomes
Primary Outcome Measures
Columbia-Suicide Severity Rating Scale, Screen Version (C-SSRS)
This scale quantifies the severity of suicidal ideation and behaviour.
Secondary Outcome Measures
Beck Hopelessness Scale (BHS)
This questionnaire assesses thoughts and emotions associated with the future.
Beck Depression Inventory II (BDI-II)
This questionnaire assesses severity of depressive symptoms and cognitions.
Positive and Negative Affect Schedule (PANAS)
This questionnaire assesses current positive and negative mood
Scrambled Sentences Tests
This computer test will be used as an implicit measure of negative interpretation bias.
Full Information
NCT ID
NCT03000699
First Posted
December 20, 2016
Last Updated
January 29, 2019
Sponsor
Centre for Addiction and Mental Health
Collaborators
American Foundation for Suicide Prevention
1. Study Identification
Unique Protocol Identification Number
NCT03000699
Brief Title
Efficacy of Cognitive Bias Modification in Residential Treatment for Addiction
Official Title
Efficacy of Cognitive Bias Modification in Residential Treatment for Addiction
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
October 1, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Addiction and Mental Health
Collaborators
American Foundation for Suicide Prevention
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine whether computer bias modification for interpretation bias (CBM-I) is effective in the reduction of suicidal ideation in substance use disorders.
Detailed Description
Eighty-eight adult inpatients completing residential treatment in the Addictions Services at the Centre for Addiction and Mental Health (CAMH) will be randomized to receive CBM-I daily for one week, adjunct to the residential psychosocial treatment or to an assessment-only control condition. Participants will complete clinical measures consisting of interviews and questionnaires measuring suicidal ideation, hopelessness, depression, negative affect, and interpretation biases before, during and after treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Dependence
Keywords
cognitive bias modification, interpretation bias, suicidal ideation, depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive Bias Modification
Arm Type
Experimental
Arm Description
64 training paragraphs, approximately 10-20 seconds each, digitally recorded and presented stereophonically through headphones, delivered over the course of one week.
Arm Title
Assessment-Only Control
Arm Type
No Intervention
Arm Description
No training will be provided.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Bias Modification
Intervention Description
Training paragraphs describe scenarios designed to be ambiguous at the outset and to resolve in a positive direction, with the intention of establishing a learning contingency between the ambiguity at the beginning of the scenario and the positive resolution that becomes clear towards the end of the statement.
Primary Outcome Measure Information:
Title
Columbia-Suicide Severity Rating Scale, Screen Version (C-SSRS)
Description
This scale quantifies the severity of suicidal ideation and behaviour.
Time Frame
Seven days
Secondary Outcome Measure Information:
Title
Beck Hopelessness Scale (BHS)
Description
This questionnaire assesses thoughts and emotions associated with the future.
Time Frame
Seven days
Title
Beck Depression Inventory II (BDI-II)
Description
This questionnaire assesses severity of depressive symptoms and cognitions.
Time Frame
Seven days
Title
Positive and Negative Affect Schedule (PANAS)
Description
This questionnaire assesses current positive and negative mood
Time Frame
Seven days
Title
Scrambled Sentences Tests
Description
This computer test will be used as an implicit measure of negative interpretation bias.
Time Frame
Seven days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Exhibit moderate suicide risk or greater
Be enrolled in the Addictions Services inpatient program
Fluent in reading English
Capacity to give informed consent
Exclusion Criteria:
A lifetime diagnosis of a psychotic or bipolar disorder
Significant neurological disorder or psychical illness likely to interfere with participation
Psychotropic medication changes within the past two weeks
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lena C Quilty, PhD
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 1R8
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.camh.ca/research
Description
Information about research at the Centre for Addiction and Mental Health
Learn more about this trial
Efficacy of Cognitive Bias Modification in Residential Treatment for Addiction
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