Efficacy of Cognitive Bias Modification in Residential Treatment for Addiction

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.

Study Overview

• Status: Completed
• Conditions: Substance Dependence
• Intervention / Treatment: Behavioral: Cognitive Bias Modification

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.

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5T 1R8
      • Centre for Addiction and Mental Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive Bias Modification; 64 training paragraphs, approximately 10-20 seconds each, digitally recorded and presented stereophonically through headphones, delivered over the course of one week.	Behavioral: Cognitive Bias Modification; 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.
No Intervention: Assessment-Only Control; No training will be provided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Columbia-Suicide Severity Rating Scale, Screen Version (C-SSRS)	This scale quantifies the severity of suicidal ideation and behaviour.	Seven days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Beck Hopelessness Scale (BHS)	This questionnaire assesses thoughts and emotions associated with the future.	Seven days
Beck Depression Inventory II (BDI-II)	This questionnaire assesses severity of depressive symptoms and cognitions.	Seven days
Positive and Negative Affect Schedule (PANAS)	This questionnaire assesses current positive and negative mood	Seven days
Scrambled Sentences Tests	This computer test will be used as an implicit measure of negative interpretation bias.	Seven days

Collaborators and Investigators

• Sponsor: Centre for Addiction and Mental Health
• Collaborators: American Foundation for Suicide Prevention
• Investigators: Principal Investigator: Lena C Quilty, PhD, Centre for Addiction and Mental Health

Publications and helpful links

Helpful Links

• Information about research at the Centre for Addiction and Mental Health

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: December 20, 2016
• First Submitted That Met QC Criteria: December 20, 2016
• First Posted (Estimate): December 22, 2016

Study Record Updates

• Last Update Posted (Actual): January 30, 2019
• Last Update Submitted That Met QC Criteria: January 29, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: depression; suicidal ideation; cognitive bias modification; interpretation bias
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: 077/2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No