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Efficacy of Cognitive Bias Modification in Residential Treatment for Addiction

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2017 by Centre for Addiction and Mental Health
Sponsor:
Collaborator:
American Foundation for Suicide Prevention
Information provided by (Responsible Party):
Lena Quilty, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier:
NCT03000699
First received: December 20, 2016
Last updated: April 3, 2017
Last verified: April 2017
  Purpose
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.

Condition Intervention
Substance Dependence
Behavioral: Cognitive Bias Modification

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Outcomes Assessor
Primary Purpose: Treatment
Official Title: Efficacy of Cognitive Bias Modification in Residential Treatment for Addiction

Resource links provided by NLM:


Further study details as provided by Centre for Addiction and Mental Health:

Primary Outcome Measures:
  • Columbia-Suicide Severity Rating Scale, Screen Version (C-SSRS) [ Time Frame: Seven days ]
    This scale quantifies the severity of suicidal ideation and behaviour.


Secondary Outcome Measures:
  • Beck Hopelessness Scale (BHS) [ Time Frame: Seven days ]
    This questionnaire assesses thoughts and emotions associated with the future.

  • Beck Depression Inventory II (BDI-II) [ Time Frame: Seven days ]
    This questionnaire assesses severity of depressive symptoms and cognitions.

  • Positive and Negative Affect Schedule (PANAS) [ Time Frame: Seven days ]
    This questionnaire assesses current positive and negative mood

  • Scrambled Sentences Tests [ Time Frame: Seven days ]
    This computer test will be used as an implicit measure of negative interpretation bias.


Estimated Enrollment: 88
Actual Study Start Date: March 1, 2017
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03000699

Contacts
Contact: Lena C Quilty, PhD 416-535-8501 ext 34313 lena.quilty@camh.ca
Contact: Lena C Quilty, PhD

Locations
Canada, Ontario
Centre for Addiction and Mental Health Recruiting
Toronto, Ontario, Canada, M5T 1R8
Contact: Lena C Quilty, PhD    416-535-8501 ext 34313    lena.quilty@camh.ca   
Sponsors and Collaborators
Centre for Addiction and Mental Health
American Foundation for Suicide Prevention
Investigators
Principal Investigator: Lena C Quilty, PhD Centre for Addiction and Mental Health
  More Information

Additional Information:
Responsible Party: Lena Quilty, Independent Scientist, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT03000699     History of Changes
Other Study ID Numbers: 077/2016
Study First Received: December 20, 2016
Last Updated: April 3, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre for Addiction and Mental Health:
cognitive bias modification
interpretation bias
suicidal ideation
depression

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 24, 2017