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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03000699
Other study ID # 077/2016
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2017
Est. completion date December 31, 2018

Study information

Verified date January 2019
Source Centre for Addiction and Mental Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 88
Est. completion date December 31, 2018
Est. primary completion date October 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Canada Centre for Addiction and Mental Health Toronto Ontario

Sponsors (2)

Lead Sponsor Collaborator
Centre for Addiction and Mental Health American Foundation for Suicide Prevention

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Columbia-Suicide Severity Rating Scale, Screen Version (C-SSRS) This scale quantifies the severity of suicidal ideation and behaviour. Seven days
Secondary Beck Hopelessness Scale (BHS) This questionnaire assesses thoughts and emotions associated with the future. Seven days
Secondary Beck Depression Inventory II (BDI-II) This questionnaire assesses severity of depressive symptoms and cognitions. Seven days
Secondary Positive and Negative Affect Schedule (PANAS) This questionnaire assesses current positive and negative mood Seven days
Secondary Scrambled Sentences Tests This computer test will be used as an implicit measure of negative interpretation bias. Seven days
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